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Serostim

&times

Overview

What is Serostim?

SEROSTIM is a human growth hormone (hGH) produced by recombinant DNA technology. SEROSTIM has 191 amino acid residues and a molecular weight of 22,125 daltons. Its amino acid sequence and structure are identical to the dominant form of human pituitary growth hormone. SEROSTIM is produced by a mammalian cell line (mouse C127) that has been modified by the addition of the hGH gene. SEROSTIM is secreted directly through the cell membrane into the cell-culture medium for collection and purification.

SEROSTIM is a sterile lyophilized powder intended for subcutaneous injection after reconstitution to its liquid form.

Vials of SEROSTIM contain either 4 mg, 5 mg, or 6 mg. Each vial contains the following:

Each 4 mg multi-vial is supplied in a combination package with Bacteriostatic Water for Injection, USP (0.9% Benzyl Alcohol). The pH is adjusted with sodium hydroxide of phosphoric acid to give a pH of 7.4 to 8.5 after reconstitution.

Each 5 mg single-use vial is supplied in a combination package with Sterile Water for Injection, USP. The pH is adjusted with sodium hydroxide or phosphoric acid to give a pH of 6.5 to 8.5 after reconstitution.

Each 6 mg single-use vial is supplied in a combination package with Sterile Water for Injection, USP. The pH is adjusted with sodium hydroxide of phosphoric acid to give a pH of 7.4 to 8.5 after reconstitution.



What does Serostim look like?



What are the available doses of Serostim?

Single-use administration (to be reconstituted with Sterile Water for Injection):

Multi-use administration (to be reconstituted with Bacteriostatic Water for Injection):

What should I talk to my health care provider before I take Serostim?

How should I use Serostim?

SEROSTIM (somatropin) is indicated for the treatment of HIV patients with wasting or cachexia to increase lean body mass and body weight, and improve physical endurance. Concomitant antiretroviral therapy is necessary.

SEROSTIM is administered by subcutaneous injection.

SEROSTIM therapy should be carried out under the regular guidance of a physician who is experienced in the diagnosis and management of HIV infection.


What interacts with Serostim?

Sorry No Records found


What are the warnings of Serostim?

Sorry No Records found


What are the precautions of Serostim?

Sorry No Records found


What are the side effects of Serostim?

Sorry No records found


What should I look out for while using Serostim?

Acute Critical Illness ()

Active Malignancy ()

Diabetic Retinopathy ()

Hypersensitivity to somatropin or excipients ()


What might happen if I take too much Serostim?


How should I store and handle Serostim?

Zenchent 28 Day [norethindrone (0.4 mg) and ethinyl estradiol (0.035 mg) tablets USP] are packaged in cartons of six blister cards (NDC 0093‐3305‐16). Each card contains 21 light peach, round, flat-faced, beveled-edge, unscored tablets, debossed with stylized b on one side and on the other side, and 7 white, round, flat-faced, beveled-edge, unscored inert tablets, debossed with stylized b on one side and on the other side.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].References are available upon request.KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Teva Pharmaceuticals USA, Inc.North Wales, PA 19454Rev. A 4/2017BRIEF SUMMARY PATIENT PACKAGE INSERTThis product (like all oral contraceptives) is intended to prevent pregnancy. It does not protect against HIV infection (AIDS) and other sexually transmitted diseases.Oral contraceptives, also known as “birth control pills” or “the pill,” are taken to prevent pregnancy and when taken correctly, have a failure rate of about 1% per year when used without missing any pills. The typical failure rate of large numbers of pill users is less than 3% per year when women who miss pills are included.Oral contraceptive use is associated with certain serious diseases that can be life-threatening or may cause temporary or permanent disability. The risks associated with taking oral contraceptives increase significantly if you:You should not take the pill if you suspect you are pregnant or have unexplained vaginal bleeding.Most side effects of the pill are not serious. The most common side effects are nausea, vomiting, bleeding between menstrual periods, weight gain, breast tenderness, and difficulty wearing contact lenses. These side effects, especially nausea and vomiting, may subside within the first three months of use.The serious side effects of the pill occur very infrequently, especially if you are in good health and are young. However, you should know that the following medical conditions have been associated with or made worse by the pill:The symptoms associated with these serious side effects are discussed in the detailed leaflet given to you with your supply of pills. Notify your doctor or healthcare provider if you notice any unusual physical disturbances while taking the pill. In addition, drugs such as rifampin, as well as some anticonvulsants and some antibiotics may decrease oral contraceptive effectiveness.Studies to date of women taking the pill have not shown an increase in the incidence of cancer of the breast or cervix. There is, however, insufficient evidence to rule out the possibility that the pill may cause such cancers.Taking the pill provides some important noncontraceptive effects. These include less painful menstruation, less menstrual blood loss and anemia, fewer pelvic infections, and fewer cancers of the ovary and the lining of the uterus.Be sure to discuss any medical condition you may have with your healthcare provider. Your healthcare provider will take a medical and family history before prescribing oral contraceptives and will examine you. The physical examination may be delayed to another time if you request it and the healthcare provider believes that it is a good medical practice to postpone it. You should be reexamined at least once a year while taking oral contraceptives. The detailed patient labeling gives you further information which you should read and discuss with your healthcare professional.DOSAGE AND ADMINISTRATIONHOW TO TAKE THE PILLThe instructions given in the insert are included inside each foil pouch. The instructions include the directions on starting the first pack on Day-One (first choice) of her period and the Sunday start (Sunday after period starts). The patient is advised that, if she used the Sunday start, she should use a back-up method in the first cycle if she has intercourse before she has taken seven pills. The patient is also instructed as to what she should do if she misses a pill or pills. The patient is warned that she may become pregnant if she misses a pill or pills and that she should use a back-up method of birth control in the event she has intercourse any time during the seven day period following the missed pill or pills.Instructions on how to use the blister card are included in the .Zenchent 28 Day [norethindrone (0.4 mg) and ethinyl estradiol (0.035 mg) tablets USP] are packaged in cartons of six blister cards (NDC 0093‐3305‐16). Each card contains 21 light peach, round, flat-faced, beveled-edge, unscored tablets, debossed with stylized b on one side and on the other side, and 7 white, round, flat-faced, beveled-edge, unscored inert tablets, debossed with stylized b on one side and on the other side.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].References are available upon request.KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Teva Pharmaceuticals USA, Inc.North Wales, PA 19454Rev. A 4/2017BRIEF SUMMARY PATIENT PACKAGE INSERTThis product (like all oral contraceptives) is intended to prevent pregnancy. It does not protect against HIV infection (AIDS) and other sexually transmitted diseases.Oral contraceptives, also known as “birth control pills” or “the pill,” are taken to prevent pregnancy and when taken correctly, have a failure rate of about 1% per year when used without missing any pills. The typical failure rate of large numbers of pill users is less than 3% per year when women who miss pills are included.Oral contraceptive use is associated with certain serious diseases that can be life-threatening or may cause temporary or permanent disability. The risks associated with taking oral contraceptives increase significantly if you:You should not take the pill if you suspect you are pregnant or have unexplained vaginal bleeding.Most side effects of the pill are not serious. The most common side effects are nausea, vomiting, bleeding between menstrual periods, weight gain, breast tenderness, and difficulty wearing contact lenses. These side effects, especially nausea and vomiting, may subside within the first three months of use.The serious side effects of the pill occur very infrequently, especially if you are in good health and are young. However, you should know that the following medical conditions have been associated with or made worse by the pill:The symptoms associated with these serious side effects are discussed in the detailed leaflet given to you with your supply of pills. Notify your doctor or healthcare provider if you notice any unusual physical disturbances while taking the pill. In addition, drugs such as rifampin, as well as some anticonvulsants and some antibiotics may decrease oral contraceptive effectiveness.Studies to date of women taking the pill have not shown an increase in the incidence of cancer of the breast or cervix. There is, however, insufficient evidence to rule out the possibility that the pill may cause such cancers.Taking the pill provides some important noncontraceptive effects. These include less painful menstruation, less menstrual blood loss and anemia, fewer pelvic infections, and fewer cancers of the ovary and the lining of the uterus.Be sure to discuss any medical condition you may have with your healthcare provider. Your healthcare provider will take a medical and family history before prescribing oral contraceptives and will examine you. The physical examination may be delayed to another time if you request it and the healthcare provider believes that it is a good medical practice to postpone it. You should be reexamined at least once a year while taking oral contraceptives. The detailed patient labeling gives you further information which you should read and discuss with your healthcare professional.DOSAGE AND ADMINISTRATIONHOW TO TAKE THE PILLThe instructions given in the insert are included inside each foil pouch. The instructions include the directions on starting the first pack on Day-One (first choice) of her period and the Sunday start (Sunday after period starts). The patient is advised that, if she used the Sunday start, she should use a back-up method in the first cycle if she has intercourse before she has taken seven pills. The patient is also instructed as to what she should do if she misses a pill or pills. The patient is warned that she may become pregnant if she misses a pill or pills and that she should use a back-up method of birth control in the event she has intercourse any time during the seven day period following the missed pill or pills.Instructions on how to use the blister card are included in the .Zenchent 28 Day [norethindrone (0.4 mg) and ethinyl estradiol (0.035 mg) tablets USP] are packaged in cartons of six blister cards (NDC 0093‐3305‐16). Each card contains 21 light peach, round, flat-faced, beveled-edge, unscored tablets, debossed with stylized b on one side and on the other side, and 7 white, round, flat-faced, beveled-edge, unscored inert tablets, debossed with stylized b on one side and on the other side.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].References are available upon request.KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Teva Pharmaceuticals USA, Inc.North Wales, PA 19454Rev. A 4/2017BRIEF SUMMARY PATIENT PACKAGE INSERTThis product (like all oral contraceptives) is intended to prevent pregnancy. It does not protect against HIV infection (AIDS) and other sexually transmitted diseases.Oral contraceptives, also known as “birth control pills” or “the pill,” are taken to prevent pregnancy and when taken correctly, have a failure rate of about 1% per year when used without missing any pills. The typical failure rate of large numbers of pill users is less than 3% per year when women who miss pills are included.Oral contraceptive use is associated with certain serious diseases that can be life-threatening or may cause temporary or permanent disability. The risks associated with taking oral contraceptives increase significantly if you:You should not take the pill if you suspect you are pregnant or have unexplained vaginal bleeding.Most side effects of the pill are not serious. The most common side effects are nausea, vomiting, bleeding between menstrual periods, weight gain, breast tenderness, and difficulty wearing contact lenses. These side effects, especially nausea and vomiting, may subside within the first three months of use.The serious side effects of the pill occur very infrequently, especially if you are in good health and are young. However, you should know that the following medical conditions have been associated with or made worse by the pill:The symptoms associated with these serious side effects are discussed in the detailed leaflet given to you with your supply of pills. Notify your doctor or healthcare provider if you notice any unusual physical disturbances while taking the pill. In addition, drugs such as rifampin, as well as some anticonvulsants and some antibiotics may decrease oral contraceptive effectiveness.Studies to date of women taking the pill have not shown an increase in the incidence of cancer of the breast or cervix. There is, however, insufficient evidence to rule out the possibility that the pill may cause such cancers.Taking the pill provides some important noncontraceptive effects. These include less painful menstruation, less menstrual blood loss and anemia, fewer pelvic infections, and fewer cancers of the ovary and the lining of the uterus.Be sure to discuss any medical condition you may have with your healthcare provider. Your healthcare provider will take a medical and family history before prescribing oral contraceptives and will examine you. The physical examination may be delayed to another time if you request it and the healthcare provider believes that it is a good medical practice to postpone it. You should be reexamined at least once a year while taking oral contraceptives. The detailed patient labeling gives you further information which you should read and discuss with your healthcare professional.DOSAGE AND ADMINISTRATIONHOW TO TAKE THE PILLThe instructions given in the insert are included inside each foil pouch. The instructions include the directions on starting the first pack on Day-One (first choice) of her period and the Sunday start (Sunday after period starts). The patient is advised that, if she used the Sunday start, she should use a back-up method in the first cycle if she has intercourse before she has taken seven pills. The patient is also instructed as to what she should do if she misses a pill or pills. The patient is warned that she may become pregnant if she misses a pill or pills and that she should use a back-up method of birth control in the event she has intercourse any time during the seven day period following the missed pill or pills.Instructions on how to use the blister card are included in the .Zenchent 28 Day [norethindrone (0.4 mg) and ethinyl estradiol (0.035 mg) tablets USP] are packaged in cartons of six blister cards (NDC 0093‐3305‐16). Each card contains 21 light peach, round, flat-faced, beveled-edge, unscored tablets, debossed with stylized b on one side and on the other side, and 7 white, round, flat-faced, beveled-edge, unscored inert tablets, debossed with stylized b on one side and on the other side.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].References are available upon request.KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Teva Pharmaceuticals USA, Inc.North Wales, PA 19454Rev. A 4/2017BRIEF SUMMARY PATIENT PACKAGE INSERTThis product (like all oral contraceptives) is intended to prevent pregnancy. It does not protect against HIV infection (AIDS) and other sexually transmitted diseases.Oral contraceptives, also known as “birth control pills” or “the pill,” are taken to prevent pregnancy and when taken correctly, have a failure rate of about 1% per year when used without missing any pills. The typical failure rate of large numbers of pill users is less than 3% per year when women who miss pills are included.Oral contraceptive use is associated with certain serious diseases that can be life-threatening or may cause temporary or permanent disability. The risks associated with taking oral contraceptives increase significantly if you:You should not take the pill if you suspect you are pregnant or have unexplained vaginal bleeding.Most side effects of the pill are not serious. The most common side effects are nausea, vomiting, bleeding between menstrual periods, weight gain, breast tenderness, and difficulty wearing contact lenses. These side effects, especially nausea and vomiting, may subside within the first three months of use.The serious side effects of the pill occur very infrequently, especially if you are in good health and are young. However, you should know that the following medical conditions have been associated with or made worse by the pill:The symptoms associated with these serious side effects are discussed in the detailed leaflet given to you with your supply of pills. Notify your doctor or healthcare provider if you notice any unusual physical disturbances while taking the pill. In addition, drugs such as rifampin, as well as some anticonvulsants and some antibiotics may decrease oral contraceptive effectiveness.Studies to date of women taking the pill have not shown an increase in the incidence of cancer of the breast or cervix. There is, however, insufficient evidence to rule out the possibility that the pill may cause such cancers.Taking the pill provides some important noncontraceptive effects. These include less painful menstruation, less menstrual blood loss and anemia, fewer pelvic infections, and fewer cancers of the ovary and the lining of the uterus.Be sure to discuss any medical condition you may have with your healthcare provider. Your healthcare provider will take a medical and family history before prescribing oral contraceptives and will examine you. The physical examination may be delayed to another time if you request it and the healthcare provider believes that it is a good medical practice to postpone it. You should be reexamined at least once a year while taking oral contraceptives. The detailed patient labeling gives you further information which you should read and discuss with your healthcare professional.DOSAGE AND ADMINISTRATIONHOW TO TAKE THE PILLThe instructions given in the insert are included inside each foil pouch. The instructions include the directions on starting the first pack on Day-One (first choice) of her period and the Sunday start (Sunday after period starts). The patient is advised that, if she used the Sunday start, she should use a back-up method in the first cycle if she has intercourse before she has taken seven pills. The patient is also instructed as to what she should do if she misses a pill or pills. The patient is warned that she may become pregnant if she misses a pill or pills and that she should use a back-up method of birth control in the event she has intercourse any time during the seven day period following the missed pill or pills.Instructions on how to use the blister card are included in the .Zenchent 28 Day [norethindrone (0.4 mg) and ethinyl estradiol (0.035 mg) tablets USP] are packaged in cartons of six blister cards (NDC 0093‐3305‐16). Each card contains 21 light peach, round, flat-faced, beveled-edge, unscored tablets, debossed with stylized b on one side and on the other side, and 7 white, round, flat-faced, beveled-edge, unscored inert tablets, debossed with stylized b on one side and on the other side.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].References are available upon request.KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Teva Pharmaceuticals USA, Inc.North Wales, PA 19454Rev. A 4/2017BRIEF SUMMARY PATIENT PACKAGE INSERTThis product (like all oral contraceptives) is intended to prevent pregnancy. It does not protect against HIV infection (AIDS) and other sexually transmitted diseases.Oral contraceptives, also known as “birth control pills” or “the pill,” are taken to prevent pregnancy and when taken correctly, have a failure rate of about 1% per year when used without missing any pills. The typical failure rate of large numbers of pill users is less than 3% per year when women who miss pills are included.Oral contraceptive use is associated with certain serious diseases that can be life-threatening or may cause temporary or permanent disability. The risks associated with taking oral contraceptives increase significantly if you:You should not take the pill if you suspect you are pregnant or have unexplained vaginal bleeding.Most side effects of the pill are not serious. The most common side effects are nausea, vomiting, bleeding between menstrual periods, weight gain, breast tenderness, and difficulty wearing contact lenses. These side effects, especially nausea and vomiting, may subside within the first three months of use.The serious side effects of the pill occur very infrequently, especially if you are in good health and are young. However, you should know that the following medical conditions have been associated with or made worse by the pill:The symptoms associated with these serious side effects are discussed in the detailed leaflet given to you with your supply of pills. Notify your doctor or healthcare provider if you notice any unusual physical disturbances while taking the pill. In addition, drugs such as rifampin, as well as some anticonvulsants and some antibiotics may decrease oral contraceptive effectiveness.Studies to date of women taking the pill have not shown an increase in the incidence of cancer of the breast or cervix. There is, however, insufficient evidence to rule out the possibility that the pill may cause such cancers.Taking the pill provides some important noncontraceptive effects. These include less painful menstruation, less menstrual blood loss and anemia, fewer pelvic infections, and fewer cancers of the ovary and the lining of the uterus.Be sure to discuss any medical condition you may have with your healthcare provider. Your healthcare provider will take a medical and family history before prescribing oral contraceptives and will examine you. The physical examination may be delayed to another time if you request it and the healthcare provider believes that it is a good medical practice to postpone it. You should be reexamined at least once a year while taking oral contraceptives. The detailed patient labeling gives you further information which you should read and discuss with your healthcare professional.DOSAGE AND ADMINISTRATIONHOW TO TAKE THE PILLThe instructions given in the insert are included inside each foil pouch. The instructions include the directions on starting the first pack on Day-One (first choice) of her period and the Sunday start (Sunday after period starts). The patient is advised that, if she used the Sunday start, she should use a back-up method in the first cycle if she has intercourse before she has taken seven pills. The patient is also instructed as to what she should do if she misses a pill or pills. The patient is warned that she may become pregnant if she misses a pill or pills and that she should use a back-up method of birth control in the event she has intercourse any time during the seven day period following the missed pill or pills.Instructions on how to use the blister card are included in the .Zenchent 28 Day [norethindrone (0.4 mg) and ethinyl estradiol (0.035 mg) tablets USP] are packaged in cartons of six blister cards (NDC 0093‐3305‐16). Each card contains 21 light peach, round, flat-faced, beveled-edge, unscored tablets, debossed with stylized b on one side and on the other side, and 7 white, round, flat-faced, beveled-edge, unscored inert tablets, debossed with stylized b on one side and on the other side.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].References are available upon request.KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Teva Pharmaceuticals USA, Inc.North Wales, PA 19454Rev. A 4/2017BRIEF SUMMARY PATIENT PACKAGE INSERTThis product (like all oral contraceptives) is intended to prevent pregnancy. It does not protect against HIV infection (AIDS) and other sexually transmitted diseases.Oral contraceptives, also known as “birth control pills” or “the pill,” are taken to prevent pregnancy and when taken correctly, have a failure rate of about 1% per year when used without missing any pills. The typical failure rate of large numbers of pill users is less than 3% per year when women who miss pills are included.Oral contraceptive use is associated with certain serious diseases that can be life-threatening or may cause temporary or permanent disability. The risks associated with taking oral contraceptives increase significantly if you:You should not take the pill if you suspect you are pregnant or have unexplained vaginal bleeding.Most side effects of the pill are not serious. The most common side effects are nausea, vomiting, bleeding between menstrual periods, weight gain, breast tenderness, and difficulty wearing contact lenses. These side effects, especially nausea and vomiting, may subside within the first three months of use.The serious side effects of the pill occur very infrequently, especially if you are in good health and are young. However, you should know that the following medical conditions have been associated with or made worse by the pill:The symptoms associated with these serious side effects are discussed in the detailed leaflet given to you with your supply of pills. Notify your doctor or healthcare provider if you notice any unusual physical disturbances while taking the pill. In addition, drugs such as rifampin, as well as some anticonvulsants and some antibiotics may decrease oral contraceptive effectiveness.Studies to date of women taking the pill have not shown an increase in the incidence of cancer of the breast or cervix. There is, however, insufficient evidence to rule out the possibility that the pill may cause such cancers.Taking the pill provides some important noncontraceptive effects. These include less painful menstruation, less menstrual blood loss and anemia, fewer pelvic infections, and fewer cancers of the ovary and the lining of the uterus.Be sure to discuss any medical condition you may have with your healthcare provider. Your healthcare provider will take a medical and family history before prescribing oral contraceptives and will examine you. The physical examination may be delayed to another time if you request it and the healthcare provider believes that it is a good medical practice to postpone it. You should be reexamined at least once a year while taking oral contraceptives. The detailed patient labeling gives you further information which you should read and discuss with your healthcare professional.DOSAGE AND ADMINISTRATIONHOW TO TAKE THE PILLThe instructions given in the insert are included inside each foil pouch. The instructions include the directions on starting the first pack on Day-One (first choice) of her period and the Sunday start (Sunday after period starts). The patient is advised that, if she used the Sunday start, she should use a back-up method in the first cycle if she has intercourse before she has taken seven pills. The patient is also instructed as to what she should do if she misses a pill or pills. The patient is warned that she may become pregnant if she misses a pill or pills and that she should use a back-up method of birth control in the event she has intercourse any time during the seven day period following the missed pill or pills.Instructions on how to use the blister card are included in the .Zenchent 28 Day [norethindrone (0.4 mg) and ethinyl estradiol (0.035 mg) tablets USP] are packaged in cartons of six blister cards (NDC 0093‐3305‐16). Each card contains 21 light peach, round, flat-faced, beveled-edge, unscored tablets, debossed with stylized b on one side and on the other side, and 7 white, round, flat-faced, beveled-edge, unscored inert tablets, debossed with stylized b on one side and on the other side.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].References are available upon request.KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Teva Pharmaceuticals USA, Inc.North Wales, PA 19454Rev. A 4/2017BRIEF SUMMARY PATIENT PACKAGE INSERTThis product (like all oral contraceptives) is intended to prevent pregnancy. It does not protect against HIV infection (AIDS) and other sexually transmitted diseases.Oral contraceptives, also known as “birth control pills” or “the pill,” are taken to prevent pregnancy and when taken correctly, have a failure rate of about 1% per year when used without missing any pills. The typical failure rate of large numbers of pill users is less than 3% per year when women who miss pills are included.Oral contraceptive use is associated with certain serious diseases that can be life-threatening or may cause temporary or permanent disability. The risks associated with taking oral contraceptives increase significantly if you:You should not take the pill if you suspect you are pregnant or have unexplained vaginal bleeding.Most side effects of the pill are not serious. The most common side effects are nausea, vomiting, bleeding between menstrual periods, weight gain, breast tenderness, and difficulty wearing contact lenses. These side effects, especially nausea and vomiting, may subside within the first three months of use.The serious side effects of the pill occur very infrequently, especially if you are in good health and are young. However, you should know that the following medical conditions have been associated with or made worse by the pill:The symptoms associated with these serious side effects are discussed in the detailed leaflet given to you with your supply of pills. Notify your doctor or healthcare provider if you notice any unusual physical disturbances while taking the pill. In addition, drugs such as rifampin, as well as some anticonvulsants and some antibiotics may decrease oral contraceptive effectiveness.Studies to date of women taking the pill have not shown an increase in the incidence of cancer of the breast or cervix. There is, however, insufficient evidence to rule out the possibility that the pill may cause such cancers.Taking the pill provides some important noncontraceptive effects. These include less painful menstruation, less menstrual blood loss and anemia, fewer pelvic infections, and fewer cancers of the ovary and the lining of the uterus.Be sure to discuss any medical condition you may have with your healthcare provider. Your healthcare provider will take a medical and family history before prescribing oral contraceptives and will examine you. The physical examination may be delayed to another time if you request it and the healthcare provider believes that it is a good medical practice to postpone it. You should be reexamined at least once a year while taking oral contraceptives. The detailed patient labeling gives you further information which you should read and discuss with your healthcare professional.DOSAGE AND ADMINISTRATIONHOW TO TAKE THE PILLThe instructions given in the insert are included inside each foil pouch. The instructions include the directions on starting the first pack on Day-One (first choice) of her period and the Sunday start (Sunday after period starts). The patient is advised that, if she used the Sunday start, she should use a back-up method in the first cycle if she has intercourse before she has taken seven pills. The patient is also instructed as to what she should do if she misses a pill or pills. The patient is warned that she may become pregnant if she misses a pill or pills and that she should use a back-up method of birth control in the event she has intercourse any time during the seven day period following the missed pill or pills.Instructions on how to use the blister card are included in the .Zenchent 28 Day [norethindrone (0.4 mg) and ethinyl estradiol (0.035 mg) tablets USP] are packaged in cartons of six blister cards (NDC 0093‐3305‐16). Each card contains 21 light peach, round, flat-faced, beveled-edge, unscored tablets, debossed with stylized b on one side and on the other side, and 7 white, round, flat-faced, beveled-edge, unscored inert tablets, debossed with stylized b on one side and on the other side.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].References are available upon request.KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Teva Pharmaceuticals USA, Inc.North Wales, PA 19454Rev. A 4/2017BRIEF SUMMARY PATIENT PACKAGE INSERTThis product (like all oral contraceptives) is intended to prevent pregnancy. It does not protect against HIV infection (AIDS) and other sexually transmitted diseases.Oral contraceptives, also known as “birth control pills” or “the pill,” are taken to prevent pregnancy and when taken correctly, have a failure rate of about 1% per year when used without missing any pills. The typical failure rate of large numbers of pill users is less than 3% per year when women who miss pills are included.Oral contraceptive use is associated with certain serious diseases that can be life-threatening or may cause temporary or permanent disability. The risks associated with taking oral contraceptives increase significantly if you:You should not take the pill if you suspect you are pregnant or have unexplained vaginal bleeding.Most side effects of the pill are not serious. The most common side effects are nausea, vomiting, bleeding between menstrual periods, weight gain, breast tenderness, and difficulty wearing contact lenses. These side effects, especially nausea and vomiting, may subside within the first three months of use.The serious side effects of the pill occur very infrequently, especially if you are in good health and are young. However, you should know that the following medical conditions have been associated with or made worse by the pill:The symptoms associated with these serious side effects are discussed in the detailed leaflet given to you with your supply of pills. Notify your doctor or healthcare provider if you notice any unusual physical disturbances while taking the pill. In addition, drugs such as rifampin, as well as some anticonvulsants and some antibiotics may decrease oral contraceptive effectiveness.Studies to date of women taking the pill have not shown an increase in the incidence of cancer of the breast or cervix. There is, however, insufficient evidence to rule out the possibility that the pill may cause such cancers.Taking the pill provides some important noncontraceptive effects. These include less painful menstruation, less menstrual blood loss and anemia, fewer pelvic infections, and fewer cancers of the ovary and the lining of the uterus.Be sure to discuss any medical condition you may have with your healthcare provider. Your healthcare provider will take a medical and family history before prescribing oral contraceptives and will examine you. The physical examination may be delayed to another time if you request it and the healthcare provider believes that it is a good medical practice to postpone it. You should be reexamined at least once a year while taking oral contraceptives. The detailed patient labeling gives you further information which you should read and discuss with your healthcare professional.DOSAGE AND ADMINISTRATIONHOW TO TAKE THE PILLThe instructions given in the insert are included inside each foil pouch. The instructions include the directions on starting the first pack on Day-One (first choice) of her period and the Sunday start (Sunday after period starts). The patient is advised that, if she used the Sunday start, she should use a back-up method in the first cycle if she has intercourse before she has taken seven pills. The patient is also instructed as to what she should do if she misses a pill or pills. The patient is warned that she may become pregnant if she misses a pill or pills and that she should use a back-up method of birth control in the event she has intercourse any time during the seven day period following the missed pill or pills.Instructions on how to use the blister card are included in the .Zenchent 28 Day [norethindrone (0.4 mg) and ethinyl estradiol (0.035 mg) tablets USP] are packaged in cartons of six blister cards (NDC 0093‐3305‐16). Each card contains 21 light peach, round, flat-faced, beveled-edge, unscored tablets, debossed with stylized b on one side and on the other side, and 7 white, round, flat-faced, beveled-edge, unscored inert tablets, debossed with stylized b on one side and on the other side.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].References are available upon request.KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Teva Pharmaceuticals USA, Inc.North Wales, PA 19454Rev. A 4/2017BRIEF SUMMARY PATIENT PACKAGE INSERTThis product (like all oral contraceptives) is intended to prevent pregnancy. It does not protect against HIV infection (AIDS) and other sexually transmitted diseases.Oral contraceptives, also known as “birth control pills” or “the pill,” are taken to prevent pregnancy and when taken correctly, have a failure rate of about 1% per year when used without missing any pills. The typical failure rate of large numbers of pill users is less than 3% per year when women who miss pills are included.Oral contraceptive use is associated with certain serious diseases that can be life-threatening or may cause temporary or permanent disability. The risks associated with taking oral contraceptives increase significantly if you:You should not take the pill if you suspect you are pregnant or have unexplained vaginal bleeding.Most side effects of the pill are not serious. The most common side effects are nausea, vomiting, bleeding between menstrual periods, weight gain, breast tenderness, and difficulty wearing contact lenses. These side effects, especially nausea and vomiting, may subside within the first three months of use.The serious side effects of the pill occur very infrequently, especially if you are in good health and are young. However, you should know that the following medical conditions have been associated with or made worse by the pill:The symptoms associated with these serious side effects are discussed in the detailed leaflet given to you with your supply of pills. Notify your doctor or healthcare provider if you notice any unusual physical disturbances while taking the pill. In addition, drugs such as rifampin, as well as some anticonvulsants and some antibiotics may decrease oral contraceptive effectiveness.Studies to date of women taking the pill have not shown an increase in the incidence of cancer of the breast or cervix. There is, however, insufficient evidence to rule out the possibility that the pill may cause such cancers.Taking the pill provides some important noncontraceptive effects. These include less painful menstruation, less menstrual blood loss and anemia, fewer pelvic infections, and fewer cancers of the ovary and the lining of the uterus.Be sure to discuss any medical condition you may have with your healthcare provider. Your healthcare provider will take a medical and family history before prescribing oral contraceptives and will examine you. The physical examination may be delayed to another time if you request it and the healthcare provider believes that it is a good medical practice to postpone it. You should be reexamined at least once a year while taking oral contraceptives. The detailed patient labeling gives you further information which you should read and discuss with your healthcare professional.DOSAGE AND ADMINISTRATIONHOW TO TAKE THE PILLThe instructions given in the insert are included inside each foil pouch. The instructions include the directions on starting the first pack on Day-One (first choice) of her period and the Sunday start (Sunday after period starts). The patient is advised that, if she used the Sunday start, she should use a back-up method in the first cycle if she has intercourse before she has taken seven pills. The patient is also instructed as to what she should do if she misses a pill or pills. The patient is warned that she may become pregnant if she misses a pill or pills and that she should use a back-up method of birth control in the event she has intercourse any time during the seven day period following the missed pill or pills.Instructions on how to use the blister card are included in the .Zenchent 28 Day [norethindrone (0.4 mg) and ethinyl estradiol (0.035 mg) tablets USP] are packaged in cartons of six blister cards (NDC 0093‐3305‐16). Each card contains 21 light peach, round, flat-faced, beveled-edge, unscored tablets, debossed with stylized b on one side and on the other side, and 7 white, round, flat-faced, beveled-edge, unscored inert tablets, debossed with stylized b on one side and on the other side.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].References are available upon request.KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Teva Pharmaceuticals USA, Inc.North Wales, PA 19454Rev. A 4/2017BRIEF SUMMARY PATIENT PACKAGE INSERTThis product (like all oral contraceptives) is intended to prevent pregnancy. It does not protect against HIV infection (AIDS) and other sexually transmitted diseases.Oral contraceptives, also known as “birth control pills” or “the pill,” are taken to prevent pregnancy and when taken correctly, have a failure rate of about 1% per year when used without missing any pills. The typical failure rate of large numbers of pill users is less than 3% per year when women who miss pills are included.Oral contraceptive use is associated with certain serious diseases that can be life-threatening or may cause temporary or permanent disability. The risks associated with taking oral contraceptives increase significantly if you:You should not take the pill if you suspect you are pregnant or have unexplained vaginal bleeding.Most side effects of the pill are not serious. The most common side effects are nausea, vomiting, bleeding between menstrual periods, weight gain, breast tenderness, and difficulty wearing contact lenses. These side effects, especially nausea and vomiting, may subside within the first three months of use.The serious side effects of the pill occur very infrequently, especially if you are in good health and are young. However, you should know that the following medical conditions have been associated with or made worse by the pill:The symptoms associated with these serious side effects are discussed in the detailed leaflet given to you with your supply of pills. Notify your doctor or healthcare provider if you notice any unusual physical disturbances while taking the pill. In addition, drugs such as rifampin, as well as some anticonvulsants and some antibiotics may decrease oral contraceptive effectiveness.Studies to date of women taking the pill have not shown an increase in the incidence of cancer of the breast or cervix. There is, however, insufficient evidence to rule out the possibility that the pill may cause such cancers.Taking the pill provides some important noncontraceptive effects. These include less painful menstruation, less menstrual blood loss and anemia, fewer pelvic infections, and fewer cancers of the ovary and the lining of the uterus.Be sure to discuss any medical condition you may have with your healthcare provider. Your healthcare provider will take a medical and family history before prescribing oral contraceptives and will examine you. The physical examination may be delayed to another time if you request it and the healthcare provider believes that it is a good medical practice to postpone it. You should be reexamined at least once a year while taking oral contraceptives. The detailed patient labeling gives you further information which you should read and discuss with your healthcare professional.DOSAGE AND ADMINISTRATIONHOW TO TAKE THE PILLThe instructions given in the insert are included inside each foil pouch. The instructions include the directions on starting the first pack on Day-One (first choice) of her period and the Sunday start (Sunday after period starts). The patient is advised that, if she used the Sunday start, she should use a back-up method in the first cycle if she has intercourse before she has taken seven pills. The patient is also instructed as to what she should do if she misses a pill or pills. The patient is warned that she may become pregnant if she misses a pill or pills and that she should use a back-up method of birth control in the event she has intercourse any time during the seven day period following the missed pill or pills.Instructions on how to use the blister card are included in the .Zenchent 28 Day [norethindrone (0.4 mg) and ethinyl estradiol (0.035 mg) tablets USP] are packaged in cartons of six blister cards (NDC 0093‐3305‐16). Each card contains 21 light peach, round, flat-faced, beveled-edge, unscored tablets, debossed with stylized b on one side and on the other side, and 7 white, round, flat-faced, beveled-edge, unscored inert tablets, debossed with stylized b on one side and on the other side.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].References are available upon request.KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Teva Pharmaceuticals USA, Inc.North Wales, PA 19454Rev. A 4/2017BRIEF SUMMARY PATIENT PACKAGE INSERTThis product (like all oral contraceptives) is intended to prevent pregnancy. It does not protect against HIV infection (AIDS) and other sexually transmitted diseases.Oral contraceptives, also known as “birth control pills” or “the pill,” are taken to prevent pregnancy and when taken correctly, have a failure rate of about 1% per year when used without missing any pills. The typical failure rate of large numbers of pill users is less than 3% per year when women who miss pills are included.Oral contraceptive use is associated with certain serious diseases that can be life-threatening or may cause temporary or permanent disability. The risks associated with taking oral contraceptives increase significantly if you:You should not take the pill if you suspect you are pregnant or have unexplained vaginal bleeding.Most side effects of the pill are not serious. The most common side effects are nausea, vomiting, bleeding between menstrual periods, weight gain, breast tenderness, and difficulty wearing contact lenses. These side effects, especially nausea and vomiting, may subside within the first three months of use.The serious side effects of the pill occur very infrequently, especially if you are in good health and are young. However, you should know that the following medical conditions have been associated with or made worse by the pill:The symptoms associated with these serious side effects are discussed in the detailed leaflet given to you with your supply of pills. Notify your doctor or healthcare provider if you notice any unusual physical disturbances while taking the pill. In addition, drugs such as rifampin, as well as some anticonvulsants and some antibiotics may decrease oral contraceptive effectiveness.Studies to date of women taking the pill have not shown an increase in the incidence of cancer of the breast or cervix. There is, however, insufficient evidence to rule out the possibility that the pill may cause such cancers.Taking the pill provides some important noncontraceptive effects. These include less painful menstruation, less menstrual blood loss and anemia, fewer pelvic infections, and fewer cancers of the ovary and the lining of the uterus.Be sure to discuss any medical condition you may have with your healthcare provider. Your healthcare provider will take a medical and family history before prescribing oral contraceptives and will examine you. The physical examination may be delayed to another time if you request it and the healthcare provider believes that it is a good medical practice to postpone it. You should be reexamined at least once a year while taking oral contraceptives. The detailed patient labeling gives you further information which you should read and discuss with your healthcare professional.DOSAGE AND ADMINISTRATIONHOW TO TAKE THE PILLThe instructions given in the insert are included inside each foil pouch. The instructions include the directions on starting the first pack on Day-One (first choice) of her period and the Sunday start (Sunday after period starts). The patient is advised that, if she used the Sunday start, she should use a back-up method in the first cycle if she has intercourse before she has taken seven pills. The patient is also instructed as to what she should do if she misses a pill or pills. The patient is warned that she may become pregnant if she misses a pill or pills and that she should use a back-up method of birth control in the event she has intercourse any time during the seven day period following the missed pill or pills.Instructions on how to use the blister card are included in the .Zenchent 28 Day [norethindrone (0.4 mg) and ethinyl estradiol (0.035 mg) tablets USP] are packaged in cartons of six blister cards (NDC 0093‐3305‐16). Each card contains 21 light peach, round, flat-faced, beveled-edge, unscored tablets, debossed with stylized b on one side and on the other side, and 7 white, round, flat-faced, beveled-edge, unscored inert tablets, debossed with stylized b on one side and on the other side.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].References are available upon request.KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Teva Pharmaceuticals USA, Inc.North Wales, PA 19454Rev. A 4/2017BRIEF SUMMARY PATIENT PACKAGE INSERTThis product (like all oral contraceptives) is intended to prevent pregnancy. It does not protect against HIV infection (AIDS) and other sexually transmitted diseases.Oral contraceptives, also known as “birth control pills” or “the pill,” are taken to prevent pregnancy and when taken correctly, have a failure rate of about 1% per year when used without missing any pills. The typical failure rate of large numbers of pill users is less than 3% per year when women who miss pills are included.Oral contraceptive use is associated with certain serious diseases that can be life-threatening or may cause temporary or permanent disability. The risks associated with taking oral contraceptives increase significantly if you:You should not take the pill if you suspect you are pregnant or have unexplained vaginal bleeding.Most side effects of the pill are not serious. The most common side effects are nausea, vomiting, bleeding between menstrual periods, weight gain, breast tenderness, and difficulty wearing contact lenses. These side effects, especially nausea and vomiting, may subside within the first three months of use.The serious side effects of the pill occur very infrequently, especially if you are in good health and are young. However, you should know that the following medical conditions have been associated with or made worse by the pill:The symptoms associated with these serious side effects are discussed in the detailed leaflet given to you with your supply of pills. Notify your doctor or healthcare provider if you notice any unusual physical disturbances while taking the pill. In addition, drugs such as rifampin, as well as some anticonvulsants and some antibiotics may decrease oral contraceptive effectiveness.Studies to date of women taking the pill have not shown an increase in the incidence of cancer of the breast or cervix. There is, however, insufficient evidence to rule out the possibility that the pill may cause such cancers.Taking the pill provides some important noncontraceptive effects. These include less painful menstruation, less menstrual blood loss and anemia, fewer pelvic infections, and fewer cancers of the ovary and the lining of the uterus.Be sure to discuss any medical condition you may have with your healthcare provider. Your healthcare provider will take a medical and family history before prescribing oral contraceptives and will examine you. The physical examination may be delayed to another time if you request it and the healthcare provider believes that it is a good medical practice to postpone it. You should be reexamined at least once a year while taking oral contraceptives. The detailed patient labeling gives you further information which you should read and discuss with your healthcare professional.DOSAGE AND ADMINISTRATIONHOW TO TAKE THE PILLThe instructions given in the insert are included inside each foil pouch. The instructions include the directions on starting the first pack on Day-One (first choice) of her period and the Sunday start (Sunday after period starts). The patient is advised that, if she used the Sunday start, she should use a back-up method in the first cycle if she has intercourse before she has taken seven pills. The patient is also instructed as to what she should do if she misses a pill or pills. The patient is warned that she may become pregnant if she misses a pill or pills and that she should use a back-up method of birth control in the event she has intercourse any time during the seven day period following the missed pill or pills.Instructions on how to use the blister card are included in the .Zenchent 28 Day [norethindrone (0.4 mg) and ethinyl estradiol (0.035 mg) tablets USP] are packaged in cartons of six blister cards (NDC 0093‐3305‐16). Each card contains 21 light peach, round, flat-faced, beveled-edge, unscored tablets, debossed with stylized b on one side and on the other side, and 7 white, round, flat-faced, beveled-edge, unscored inert tablets, debossed with stylized b on one side and on the other side.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].References are available upon request.KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Teva Pharmaceuticals USA, Inc.North Wales, PA 19454Rev. A 4/2017BRIEF SUMMARY PATIENT PACKAGE INSERTThis product (like all oral contraceptives) is intended to prevent pregnancy. It does not protect against HIV infection (AIDS) and other sexually transmitted diseases.Oral contraceptives, also known as “birth control pills” or “the pill,” are taken to prevent pregnancy and when taken correctly, have a failure rate of about 1% per year when used without missing any pills. The typical failure rate of large numbers of pill users is less than 3% per year when women who miss pills are included.Oral contraceptive use is associated with certain serious diseases that can be life-threatening or may cause temporary or permanent disability. The risks associated with taking oral contraceptives increase significantly if you:You should not take the pill if you suspect you are pregnant or have unexplained vaginal bleeding.Most side effects of the pill are not serious. The most common side effects are nausea, vomiting, bleeding between menstrual periods, weight gain, breast tenderness, and difficulty wearing contact lenses. These side effects, especially nausea and vomiting, may subside within the first three months of use.The serious side effects of the pill occur very infrequently, especially if you are in good health and are young. However, you should know that the following medical conditions have been associated with or made worse by the pill:The symptoms associated with these serious side effects are discussed in the detailed leaflet given to you with your supply of pills. Notify your doctor or healthcare provider if you notice any unusual physical disturbances while taking the pill. In addition, drugs such as rifampin, as well as some anticonvulsants and some antibiotics may decrease oral contraceptive effectiveness.Studies to date of women taking the pill have not shown an increase in the incidence of cancer of the breast or cervix. There is, however, insufficient evidence to rule out the possibility that the pill may cause such cancers.Taking the pill provides some important noncontraceptive effects. These include less painful menstruation, less menstrual blood loss and anemia, fewer pelvic infections, and fewer cancers of the ovary and the lining of the uterus.Be sure to discuss any medical condition you may have with your healthcare provider. Your healthcare provider will take a medical and family history before prescribing oral contraceptives and will examine you. The physical examination may be delayed to another time if you request it and the healthcare provider believes that it is a good medical practice to postpone it. You should be reexamined at least once a year while taking oral contraceptives. The detailed patient labeling gives you further information which you should read and discuss with your healthcare professional.DOSAGE AND ADMINISTRATIONHOW TO TAKE THE PILLThe instructions given in the insert are included inside each foil pouch. The instructions include the directions on starting the first pack on Day-One (first choice) of her period and the Sunday start (Sunday after period starts). The patient is advised that, if she used the Sunday start, she should use a back-up method in the first cycle if she has intercourse before she has taken seven pills. The patient is also instructed as to what she should do if she misses a pill or pills. The patient is warned that she may become pregnant if she misses a pill or pills and that she should use a back-up method of birth control in the event she has intercourse any time during the seven day period following the missed pill or pills.Instructions on how to use the blister card are included in the .Zenchent 28 Day [norethindrone (0.4 mg) and ethinyl estradiol (0.035 mg) tablets USP] are packaged in cartons of six blister cards (NDC 0093‐3305‐16). Each card contains 21 light peach, round, flat-faced, beveled-edge, unscored tablets, debossed with stylized b on one side and on the other side, and 7 white, round, flat-faced, beveled-edge, unscored inert tablets, debossed with stylized b on one side and on the other side.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].References are available upon request.KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Teva Pharmaceuticals USA, Inc.North Wales, PA 19454Rev. A 4/2017BRIEF SUMMARY PATIENT PACKAGE INSERTThis product (like all oral contraceptives) is intended to prevent pregnancy. It does not protect against HIV infection (AIDS) and other sexually transmitted diseases.Oral contraceptives, also known as “birth control pills” or “the pill,” are taken to prevent pregnancy and when taken correctly, have a failure rate of about 1% per year when used without missing any pills. The typical failure rate of large numbers of pill users is less than 3% per year when women who miss pills are included.Oral contraceptive use is associated with certain serious diseases that can be life-threatening or may cause temporary or permanent disability. The risks associated with taking oral contraceptives increase significantly if you:You should not take the pill if you suspect you are pregnant or have unexplained vaginal bleeding.Most side effects of the pill are not serious. The most common side effects are nausea, vomiting, bleeding between menstrual periods, weight gain, breast tenderness, and difficulty wearing contact lenses. These side effects, especially nausea and vomiting, may subside within the first three months of use.The serious side effects of the pill occur very infrequently, especially if you are in good health and are young. However, you should know that the following medical conditions have been associated with or made worse by the pill:The symptoms associated with these serious side effects are discussed in the detailed leaflet given to you with your supply of pills. Notify your doctor or healthcare provider if you notice any unusual physical disturbances while taking the pill. In addition, drugs such as rifampin, as well as some anticonvulsants and some antibiotics may decrease oral contraceptive effectiveness.Studies to date of women taking the pill have not shown an increase in the incidence of cancer of the breast or cervix. There is, however, insufficient evidence to rule out the possibility that the pill may cause such cancers.Taking the pill provides some important noncontraceptive effects. These include less painful menstruation, less menstrual blood loss and anemia, fewer pelvic infections, and fewer cancers of the ovary and the lining of the uterus.Be sure to discuss any medical condition you may have with your healthcare provider. Your healthcare provider will take a medical and family history before prescribing oral contraceptives and will examine you. The physical examination may be delayed to another time if you request it and the healthcare provider believes that it is a good medical practice to postpone it. You should be reexamined at least once a year while taking oral contraceptives. The detailed patient labeling gives you further information which you should read and discuss with your healthcare professional.DOSAGE AND ADMINISTRATIONHOW TO TAKE THE PILLThe instructions given in the insert are included inside each foil pouch. The instructions include the directions on starting the first pack on Day-One (first choice) of her period and the Sunday start (Sunday after period starts). The patient is advised that, if she used the Sunday start, she should use a back-up method in the first cycle if she has intercourse before she has taken seven pills. The patient is also instructed as to what she should do if she misses a pill or pills. The patient is warned that she may become pregnant if she misses a pill or pills and that she should use a back-up method of birth control in the event she has intercourse any time during the seven day period following the missed pill or pills.Instructions on how to use the blister card are included in the .Zenchent 28 Day [norethindrone (0.4 mg) and ethinyl estradiol (0.035 mg) tablets USP] are packaged in cartons of six blister cards (NDC 0093‐3305‐16). Each card contains 21 light peach, round, flat-faced, beveled-edge, unscored tablets, debossed with stylized b on one side and on the other side, and 7 white, round, flat-faced, beveled-edge, unscored inert tablets, debossed with stylized b on one side and on the other side.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].References are available upon request.KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Teva Pharmaceuticals USA, Inc.North Wales, PA 19454Rev. A 4/2017BRIEF SUMMARY PATIENT PACKAGE INSERTThis product (like all oral contraceptives) is intended to prevent pregnancy. It does not protect against HIV infection (AIDS) and other sexually transmitted diseases.Oral contraceptives, also known as “birth control pills” or “the pill,” are taken to prevent pregnancy and when taken correctly, have a failure rate of about 1% per year when used without missing any pills. The typical failure rate of large numbers of pill users is less than 3% per year when women who miss pills are included.Oral contraceptive use is associated with certain serious diseases that can be life-threatening or may cause temporary or permanent disability. The risks associated with taking oral contraceptives increase significantly if you:You should not take the pill if you suspect you are pregnant or have unexplained vaginal bleeding.Most side effects of the pill are not serious. The most common side effects are nausea, vomiting, bleeding between menstrual periods, weight gain, breast tenderness, and difficulty wearing contact lenses. These side effects, especially nausea and vomiting, may subside within the first three months of use.The serious side effects of the pill occur very infrequently, especially if you are in good health and are young. However, you should know that the following medical conditions have been associated with or made worse by the pill:The symptoms associated with these serious side effects are discussed in the detailed leaflet given to you with your supply of pills. Notify your doctor or healthcare provider if you notice any unusual physical disturbances while taking the pill. In addition, drugs such as rifampin, as well as some anticonvulsants and some antibiotics may decrease oral contraceptive effectiveness.Studies to date of women taking the pill have not shown an increase in the incidence of cancer of the breast or cervix. There is, however, insufficient evidence to rule out the possibility that the pill may cause such cancers.Taking the pill provides some important noncontraceptive effects. These include less painful menstruation, less menstrual blood loss and anemia, fewer pelvic infections, and fewer cancers of the ovary and the lining of the uterus.Be sure to discuss any medical condition you may have with your healthcare provider. Your healthcare provider will take a medical and family history before prescribing oral contraceptives and will examine you. The physical examination may be delayed to another time if you request it and the healthcare provider believes that it is a good medical practice to postpone it. You should be reexamined at least once a year while taking oral contraceptives. The detailed patient labeling gives you further information which you should read and discuss with your healthcare professional.DOSAGE AND ADMINISTRATIONHOW TO TAKE THE PILLThe instructions given in the insert are included inside each foil pouch. The instructions include the directions on starting the first pack on Day-One (first choice) of her period and the Sunday start (Sunday after period starts). The patient is advised that, if she used the Sunday start, she should use a back-up method in the first cycle if she has intercourse before she has taken seven pills. The patient is also instructed as to what she should do if she misses a pill or pills. The patient is warned that she may become pregnant if she misses a pill or pills and that she should use a back-up method of birth control in the event she has intercourse any time during the seven day period following the missed pill or pills.Instructions on how to use the blister card are included in the .Zenchent 28 Day [norethindrone (0.4 mg) and ethinyl estradiol (0.035 mg) tablets USP] are packaged in cartons of six blister cards (NDC 0093‐3305‐16). Each card contains 21 light peach, round, flat-faced, beveled-edge, unscored tablets, debossed with stylized b on one side and on the other side, and 7 white, round, flat-faced, beveled-edge, unscored inert tablets, debossed with stylized b on one side and on the other side.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].References are available upon request.KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Teva Pharmaceuticals USA, Inc.North Wales, PA 19454Rev. A 4/2017BRIEF SUMMARY PATIENT PACKAGE INSERTThis product (like all oral contraceptives) is intended to prevent pregnancy. It does not protect against HIV infection (AIDS) and other sexually transmitted diseases.Oral contraceptives, also known as “birth control pills” or “the pill,” are taken to prevent pregnancy and when taken correctly, have a failure rate of about 1% per year when used without missing any pills. The typical failure rate of large numbers of pill users is less than 3% per year when women who miss pills are included.Oral contraceptive use is associated with certain serious diseases that can be life-threatening or may cause temporary or permanent disability. The risks associated with taking oral contraceptives increase significantly if you:You should not take the pill if you suspect you are pregnant or have unexplained vaginal bleeding.Most side effects of the pill are not serious. The most common side effects are nausea, vomiting, bleeding between menstrual periods, weight gain, breast tenderness, and difficulty wearing contact lenses. These side effects, especially nausea and vomiting, may subside within the first three months of use.The serious side effects of the pill occur very infrequently, especially if you are in good health and are young. However, you should know that the following medical conditions have been associated with or made worse by the pill:The symptoms associated with these serious side effects are discussed in the detailed leaflet given to you with your supply of pills. Notify your doctor or healthcare provider if you notice any unusual physical disturbances while taking the pill. In addition, drugs such as rifampin, as well as some anticonvulsants and some antibiotics may decrease oral contraceptive effectiveness.Studies to date of women taking the pill have not shown an increase in the incidence of cancer of the breast or cervix. There is, however, insufficient evidence to rule out the possibility that the pill may cause such cancers.Taking the pill provides some important noncontraceptive effects. These include less painful menstruation, less menstrual blood loss and anemia, fewer pelvic infections, and fewer cancers of the ovary and the lining of the uterus.Be sure to discuss any medical condition you may have with your healthcare provider. Your healthcare provider will take a medical and family history before prescribing oral contraceptives and will examine you. The physical examination may be delayed to another time if you request it and the healthcare provider believes that it is a good medical practice to postpone it. You should be reexamined at least once a year while taking oral contraceptives. The detailed patient labeling gives you further information which you should read and discuss with your healthcare professional.DOSAGE AND ADMINISTRATIONHOW TO TAKE THE PILLThe instructions given in the insert are included inside each foil pouch. The instructions include the directions on starting the first pack on Day-One (first choice) of her period and the Sunday start (Sunday after period starts). The patient is advised that, if she used the Sunday start, she should use a back-up method in the first cycle if she has intercourse before she has taken seven pills. The patient is also instructed as to what she should do if she misses a pill or pills. The patient is warned that she may become pregnant if she misses a pill or pills and that she should use a back-up method of birth control in the event she has intercourse any time during the seven day period following the missed pill or pills.Instructions on how to use the blister card are included in the .Zenchent 28 Day [norethindrone (0.4 mg) and ethinyl estradiol (0.035 mg) tablets USP] are packaged in cartons of six blister cards (NDC 0093‐3305‐16). Each card contains 21 light peach, round, flat-faced, beveled-edge, unscored tablets, debossed with stylized b on one side and on the other side, and 7 white, round, flat-faced, beveled-edge, unscored inert tablets, debossed with stylized b on one side and on the other side.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].References are available upon request.KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Teva Pharmaceuticals USA, Inc.North Wales, PA 19454Rev. A 4/2017BRIEF SUMMARY PATIENT PACKAGE INSERTThis product (like all oral contraceptives) is intended to prevent pregnancy. It does not protect against HIV infection (AIDS) and other sexually transmitted diseases.Oral contraceptives, also known as “birth control pills” or “the pill,” are taken to prevent pregnancy and when taken correctly, have a failure rate of about 1% per year when used without missing any pills. The typical failure rate of large numbers of pill users is less than 3% per year when women who miss pills are included.Oral contraceptive use is associated with certain serious diseases that can be life-threatening or may cause temporary or permanent disability. The risks associated with taking oral contraceptives increase significantly if you:You should not take the pill if you suspect you are pregnant or have unexplained vaginal bleeding.Most side effects of the pill are not serious. The most common side effects are nausea, vomiting, bleeding between menstrual periods, weight gain, breast tenderness, and difficulty wearing contact lenses. These side effects, especially nausea and vomiting, may subside within the first three months of use.The serious side effects of the pill occur very infrequently, especially if you are in good health and are young. However, you should know that the following medical conditions have been associated with or made worse by the pill:The symptoms associated with these serious side effects are discussed in the detailed leaflet given to you with your supply of pills. Notify your doctor or healthcare provider if you notice any unusual physical disturbances while taking the pill. In addition, drugs such as rifampin, as well as some anticonvulsants and some antibiotics may decrease oral contraceptive effectiveness.Studies to date of women taking the pill have not shown an increase in the incidence of cancer of the breast or cervix. There is, however, insufficient evidence to rule out the possibility that the pill may cause such cancers.Taking the pill provides some important noncontraceptive effects. These include less painful menstruation, less menstrual blood loss and anemia, fewer pelvic infections, and fewer cancers of the ovary and the lining of the uterus.Be sure to discuss any medical condition you may have with your healthcare provider. Your healthcare provider will take a medical and family history before prescribing oral contraceptives and will examine you. The physical examination may be delayed to another time if you request it and the healthcare provider believes that it is a good medical practice to postpone it. You should be reexamined at least once a year while taking oral contraceptives. The detailed patient labeling gives you further information which you should read and discuss with your healthcare professional.DOSAGE AND ADMINISTRATIONHOW TO TAKE THE PILLThe instructions given in the insert are included inside each foil pouch. The instructions include the directions on starting the first pack on Day-One (first choice) of her period and the Sunday start (Sunday after period starts). The patient is advised that, if she used the Sunday start, she should use a back-up method in the first cycle if she has intercourse before she has taken seven pills. The patient is also instructed as to what she should do if she misses a pill or pills. The patient is warned that she may become pregnant if she misses a pill or pills and that she should use a back-up method of birth control in the event she has intercourse any time during the seven day period following the missed pill or pills.Instructions on how to use the blister card are included in the .Zenchent 28 Day [norethindrone (0.4 mg) and ethinyl estradiol (0.035 mg) tablets USP] are packaged in cartons of six blister cards (NDC 0093‐3305‐16). Each card contains 21 light peach, round, flat-faced, beveled-edge, unscored tablets, debossed with stylized b on one side and on the other side, and 7 white, round, flat-faced, beveled-edge, unscored inert tablets, debossed with stylized b on one side and on the other side.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].References are available upon request.KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Teva Pharmaceuticals USA, Inc.North Wales, PA 19454Rev. A 4/2017BRIEF SUMMARY PATIENT PACKAGE INSERTThis product (like all oral contraceptives) is intended to prevent pregnancy. It does not protect against HIV infection (AIDS) and other sexually transmitted diseases.Oral contraceptives, also known as “birth control pills” or “the pill,” are taken to prevent pregnancy and when taken correctly, have a failure rate of about 1% per year when used without missing any pills. The typical failure rate of large numbers of pill users is less than 3% per year when women who miss pills are included.Oral contraceptive use is associated with certain serious diseases that can be life-threatening or may cause temporary or permanent disability. The risks associated with taking oral contraceptives increase significantly if you:You should not take the pill if you suspect you are pregnant or have unexplained vaginal bleeding.Most side effects of the pill are not serious. The most common side effects are nausea, vomiting, bleeding between menstrual periods, weight gain, breast tenderness, and difficulty wearing contact lenses. These side effects, especially nausea and vomiting, may subside within the first three months of use.The serious side effects of the pill occur very infrequently, especially if you are in good health and are young. However, you should know that the following medical conditions have been associated with or made worse by the pill:The symptoms associated with these serious side effects are discussed in the detailed leaflet given to you with your supply of pills. Notify your doctor or healthcare provider if you notice any unusual physical disturbances while taking the pill. In addition, drugs such as rifampin, as well as some anticonvulsants and some antibiotics may decrease oral contraceptive effectiveness.Studies to date of women taking the pill have not shown an increase in the incidence of cancer of the breast or cervix. There is, however, insufficient evidence to rule out the possibility that the pill may cause such cancers.Taking the pill provides some important noncontraceptive effects. These include less painful menstruation, less menstrual blood loss and anemia, fewer pelvic infections, and fewer cancers of the ovary and the lining of the uterus.Be sure to discuss any medical condition you may have with your healthcare provider. Your healthcare provider will take a medical and family history before prescribing oral contraceptives and will examine you. The physical examination may be delayed to another time if you request it and the healthcare provider believes that it is a good medical practice to postpone it. You should be reexamined at least once a year while taking oral contraceptives. The detailed patient labeling gives you further information which you should read and discuss with your healthcare professional.DOSAGE AND ADMINISTRATIONHOW TO TAKE THE PILLThe instructions given in the insert are included inside each foil pouch. The instructions include the directions on starting the first pack on Day-One (first choice) of her period and the Sunday start (Sunday after period starts). The patient is advised that, if she used the Sunday start, she should use a back-up method in the first cycle if she has intercourse before she has taken seven pills. The patient is also instructed as to what she should do if she misses a pill or pills. The patient is warned that she may become pregnant if she misses a pill or pills and that she should use a back-up method of birth control in the event she has intercourse any time during the seven day period following the missed pill or pills.Instructions on how to use the blister card are included in the .Zenchent 28 Day [norethindrone (0.4 mg) and ethinyl estradiol (0.035 mg) tablets USP] are packaged in cartons of six blister cards (NDC 0093‐3305‐16). Each card contains 21 light peach, round, flat-faced, beveled-edge, unscored tablets, debossed with stylized b on one side and on the other side, and 7 white, round, flat-faced, beveled-edge, unscored inert tablets, debossed with stylized b on one side and on the other side.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].References are available upon request.KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Teva Pharmaceuticals USA, Inc.North Wales, PA 19454Rev. A 4/2017BRIEF SUMMARY PATIENT PACKAGE INSERTThis product (like all oral contraceptives) is intended to prevent pregnancy. It does not protect against HIV infection (AIDS) and other sexually transmitted diseases.Oral contraceptives, also known as “birth control pills” or “the pill,” are taken to prevent pregnancy and when taken correctly, have a failure rate of about 1% per year when used without missing any pills. The typical failure rate of large numbers of pill users is less than 3% per year when women who miss pills are included.Oral contraceptive use is associated with certain serious diseases that can be life-threatening or may cause temporary or permanent disability. The risks associated with taking oral contraceptives increase significantly if you:You should not take the pill if you suspect you are pregnant or have unexplained vaginal bleeding.Most side effects of the pill are not serious. The most common side effects are nausea, vomiting, bleeding between menstrual periods, weight gain, breast tenderness, and difficulty wearing contact lenses. These side effects, especially nausea and vomiting, may subside within the first three months of use.The serious side effects of the pill occur very infrequently, especially if you are in good health and are young. However, you should know that the following medical conditions have been associated with or made worse by the pill:The symptoms associated with these serious side effects are discussed in the detailed leaflet given to you with your supply of pills. Notify your doctor or healthcare provider if you notice any unusual physical disturbances while taking the pill. In addition, drugs such as rifampin, as well as some anticonvulsants and some antibiotics may decrease oral contraceptive effectiveness.Studies to date of women taking the pill have not shown an increase in the incidence of cancer of the breast or cervix. There is, however, insufficient evidence to rule out the possibility that the pill may cause such cancers.Taking the pill provides some important noncontraceptive effects. These include less painful menstruation, less menstrual blood loss and anemia, fewer pelvic infections, and fewer cancers of the ovary and the lining of the uterus.Be sure to discuss any medical condition you may have with your healthcare provider. Your healthcare provider will take a medical and family history before prescribing oral contraceptives and will examine you. The physical examination may be delayed to another time if you request it and the healthcare provider believes that it is a good medical practice to postpone it. You should be reexamined at least once a year while taking oral contraceptives. The detailed patient labeling gives you further information which you should read and discuss with your healthcare professional.DOSAGE AND ADMINISTRATIONHOW TO TAKE THE PILLThe instructions given in the insert are included inside each foil pouch. The instructions include the directions on starting the first pack on Day-One (first choice) of her period and the Sunday start (Sunday after period starts). The patient is advised that, if she used the Sunday start, she should use a back-up method in the first cycle if she has intercourse before she has taken seven pills. The patient is also instructed as to what she should do if she misses a pill or pills. The patient is warned that she may become pregnant if she misses a pill or pills and that she should use a back-up method of birth control in the event she has intercourse any time during the seven day period following the missed pill or pills.Instructions on how to use the blister card are included in the .Zenchent 28 Day [norethindrone (0.4 mg) and ethinyl estradiol (0.035 mg) tablets USP] are packaged in cartons of six blister cards (NDC 0093‐3305‐16). Each card contains 21 light peach, round, flat-faced, beveled-edge, unscored tablets, debossed with stylized b on one side and on the other side, and 7 white, round, flat-faced, beveled-edge, unscored inert tablets, debossed with stylized b on one side and on the other side.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].References are available upon request.KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Teva Pharmaceuticals USA, Inc.North Wales, PA 19454Rev. A 4/2017BRIEF SUMMARY PATIENT PACKAGE INSERTThis product (like all oral contraceptives) is intended to prevent pregnancy. It does not protect against HIV infection (AIDS) and other sexually transmitted diseases.Oral contraceptives, also known as “birth control pills” or “the pill,” are taken to prevent pregnancy and when taken correctly, have a failure rate of about 1% per year when used without missing any pills. The typical failure rate of large numbers of pill users is less than 3% per year when women who miss pills are included.Oral contraceptive use is associated with certain serious diseases that can be life-threatening or may cause temporary or permanent disability. The risks associated with taking oral contraceptives increase significantly if you:You should not take the pill if you suspect you are pregnant or have unexplained vaginal bleeding.Most side effects of the pill are not serious. The most common side effects are nausea, vomiting, bleeding between menstrual periods, weight gain, breast tenderness, and difficulty wearing contact lenses. These side effects, especially nausea and vomiting, may subside within the first three months of use.The serious side effects of the pill occur very infrequently, especially if you are in good health and are young. However, you should know that the following medical conditions have been associated with or made worse by the pill:The symptoms associated with these serious side effects are discussed in the detailed leaflet given to you with your supply of pills. Notify your doctor or healthcare provider if you notice any unusual physical disturbances while taking the pill. In addition, drugs such as rifampin, as well as some anticonvulsants and some antibiotics may decrease oral contraceptive effectiveness.Studies to date of women taking the pill have not shown an increase in the incidence of cancer of the breast or cervix. There is, however, insufficient evidence to rule out the possibility that the pill may cause such cancers.Taking the pill provides some important noncontraceptive effects. These include less painful menstruation, less menstrual blood loss and anemia, fewer pelvic infections, and fewer cancers of the ovary and the lining of the uterus.Be sure to discuss any medical condition you may have with your healthcare provider. Your healthcare provider will take a medical and family history before prescribing oral contraceptives and will examine you. The physical examination may be delayed to another time if you request it and the healthcare provider believes that it is a good medical practice to postpone it. You should be reexamined at least once a year while taking oral contraceptives. The detailed patient labeling gives you further information which you should read and discuss with your healthcare professional.DOSAGE AND ADMINISTRATIONHOW TO TAKE THE PILLThe instructions given in the insert are included inside each foil pouch. The instructions include the directions on starting the first pack on Day-One (first choice) of her period and the Sunday start (Sunday after period starts). The patient is advised that, if she used the Sunday start, she should use a back-up method in the first cycle if she has intercourse before she has taken seven pills. The patient is also instructed as to what she should do if she misses a pill or pills. The patient is warned that she may become pregnant if she misses a pill or pills and that she should use a back-up method of birth control in the event she has intercourse any time during the seven day period following the missed pill or pills.Instructions on how to use the blister card are included in the .Zenchent 28 Day [norethindrone (0.4 mg) and ethinyl estradiol (0.035 mg) tablets USP] are packaged in cartons of six blister cards (NDC 0093‐3305‐16). Each card contains 21 light peach, round, flat-faced, beveled-edge, unscored tablets, debossed with stylized b on one side and on the other side, and 7 white, round, flat-faced, beveled-edge, unscored inert tablets, debossed with stylized b on one side and on the other side.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].References are available upon request.KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Teva Pharmaceuticals USA, Inc.North Wales, PA 19454Rev. A 4/2017BRIEF SUMMARY PATIENT PACKAGE INSERTThis product (like all oral contraceptives) is intended to prevent pregnancy. It does not protect against HIV infection (AIDS) and other sexually transmitted diseases.Oral contraceptives, also known as “birth control pills” or “the pill,” are taken to prevent pregnancy and when taken correctly, have a failure rate of about 1% per year when used without missing any pills. The typical failure rate of large numbers of pill users is less than 3% per year when women who miss pills are included.Oral contraceptive use is associated with certain serious diseases that can be life-threatening or may cause temporary or permanent disability. The risks associated with taking oral contraceptives increase significantly if you:You should not take the pill if you suspect you are pregnant or have unexplained vaginal bleeding.Most side effects of the pill are not serious. The most common side effects are nausea, vomiting, bleeding between menstrual periods, weight gain, breast tenderness, and difficulty wearing contact lenses. These side effects, especially nausea and vomiting, may subside within the first three months of use.The serious side effects of the pill occur very infrequently, especially if you are in good health and are young. However, you should know that the following medical conditions have been associated with or made worse by the pill:The symptoms associated with these serious side effects are discussed in the detailed leaflet given to you with your supply of pills. Notify your doctor or healthcare provider if you notice any unusual physical disturbances while taking the pill. In addition, drugs such as rifampin, as well as some anticonvulsants and some antibiotics may decrease oral contraceptive effectiveness.Studies to date of women taking the pill have not shown an increase in the incidence of cancer of the breast or cervix. There is, however, insufficient evidence to rule out the possibility that the pill may cause such cancers.Taking the pill provides some important noncontraceptive effects. These include less painful menstruation, less menstrual blood loss and anemia, fewer pelvic infections, and fewer cancers of the ovary and the lining of the uterus.Be sure to discuss any medical condition you may have with your healthcare provider. Your healthcare provider will take a medical and family history before prescribing oral contraceptives and will examine you. The physical examination may be delayed to another time if you request it and the healthcare provider believes that it is a good medical practice to postpone it. You should be reexamined at least once a year while taking oral contraceptives. The detailed patient labeling gives you further information which you should read and discuss with your healthcare professional.DOSAGE AND ADMINISTRATIONHOW TO TAKE THE PILLThe instructions given in the insert are included inside each foil pouch. The instructions include the directions on starting the first pack on Day-One (first choice) of her period and the Sunday start (Sunday after period starts). The patient is advised that, if she used the Sunday start, she should use a back-up method in the first cycle if she has intercourse before she has taken seven pills. The patient is also instructed as to what she should do if she misses a pill or pills. The patient is warned that she may become pregnant if she misses a pill or pills and that she should use a back-up method of birth control in the event she has intercourse any time during the seven day period following the missed pill or pills.Instructions on how to use the blister card are included in the .Zenchent 28 Day [norethindrone (0.4 mg) and ethinyl estradiol (0.035 mg) tablets USP] are packaged in cartons of six blister cards (NDC 0093‐3305‐16). Each card contains 21 light peach, round, flat-faced, beveled-edge, unscored tablets, debossed with stylized b on one side and on the other side, and 7 white, round, flat-faced, beveled-edge, unscored inert tablets, debossed with stylized b on one side and on the other side.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].References are available upon request.KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Teva Pharmaceuticals USA, Inc.North Wales, PA 19454Rev. A 4/2017BRIEF SUMMARY PATIENT PACKAGE INSERTThis product (like all oral contraceptives) is intended to prevent pregnancy. It does not protect against HIV infection (AIDS) and other sexually transmitted diseases.Oral contraceptives, also known as “birth control pills” or “the pill,” are taken to prevent pregnancy and when taken correctly, have a failure rate of about 1% per year when used without missing any pills. The typical failure rate of large numbers of pill users is less than 3% per year when women who miss pills are included.Oral contraceptive use is associated with certain serious diseases that can be life-threatening or may cause temporary or permanent disability. The risks associated with taking oral contraceptives increase significantly if you:You should not take the pill if you suspect you are pregnant or have unexplained vaginal bleeding.Most side effects of the pill are not serious. The most common side effects are nausea, vomiting, bleeding between menstrual periods, weight gain, breast tenderness, and difficulty wearing contact lenses. These side effects, especially nausea and vomiting, may subside within the first three months of use.The serious side effects of the pill occur very infrequently, especially if you are in good health and are young. However, you should know that the following medical conditions have been associated with or made worse by the pill:The symptoms associated with these serious side effects are discussed in the detailed leaflet given to you with your supply of pills. Notify your doctor or healthcare provider if you notice any unusual physical disturbances while taking the pill. In addition, drugs such as rifampin, as well as some anticonvulsants and some antibiotics may decrease oral contraceptive effectiveness.Studies to date of women taking the pill have not shown an increase in the incidence of cancer of the breast or cervix. There is, however, insufficient evidence to rule out the possibility that the pill may cause such cancers.Taking the pill provides some important noncontraceptive effects. These include less painful menstruation, less menstrual blood loss and anemia, fewer pelvic infections, and fewer cancers of the ovary and the lining of the uterus.Be sure to discuss any medical condition you may have with your healthcare provider. Your healthcare provider will take a medical and family history before prescribing oral contraceptives and will examine you. The physical examination may be delayed to another time if you request it and the healthcare provider believes that it is a good medical practice to postpone it. You should be reexamined at least once a year while taking oral contraceptives. The detailed patient labeling gives you further information which you should read and discuss with your healthcare professional.DOSAGE AND ADMINISTRATIONHOW TO TAKE THE PILLThe instructions given in the insert are included inside each foil pouch. The instructions include the directions on starting the first pack on Day-One (first choice) of her period and the Sunday start (Sunday after period starts). The patient is advised that, if she used the Sunday start, she should use a back-up method in the first cycle if she has intercourse before she has taken seven pills. The patient is also instructed as to what she should do if she misses a pill or pills. The patient is warned that she may become pregnant if she misses a pill or pills and that she should use a back-up method of birth control in the event she has intercourse any time during the seven day period following the missed pill or pills.Instructions on how to use the blister card are included in the .


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Clinical Information

Chemical Structure

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Clinical Pharmacology

SEROSTIM is an anabolic and anticatabolic agent which exerts its influence by interacting with specific receptors on a variety of cell types including myocytes, hepatocytes, adipocytes, lymphocytes, and hematopoietic cells. Some, but not all of its effects, are mediated by insulin-like growth factor-1 (IGF-1).

Non-Clinical Toxicology
Acute Critical Illness ()

Active Malignancy ()

Diabetic Retinopathy ()

Hypersensitivity to somatropin or excipients ()

Antacids containing magnesium trisilicate, when administered concomitantly with nitrofurantoin, reduce both the rate and extent of absorption. The mechanism for this interaction probably is adsorption of nitrofurantoin onto the surface of magnesium trisilicate.

Uricosuric drugs, such as probenecid and sulfinpyrazone, can inhibit renal tubular secretion of nitrofurantoin. The resulting increase in nitrofurantoin serum levels may increase toxicity, and the decreased urinary levels could lessen its efficacy as a urinary tract antibacterial.

DRUG/LABORATORY TEST INTERACTIONS

As a result of the presence of nitrofurantoin, a false-positive reaction for glucose in the urine may occur. This has been observed with Benedict's and Fehling's solutions but not with the glucose enzymatic test.

Increased mortality in patients with acute critical illness due to complications following open heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure has been reported after treatment with amounts of somatropin. Two placebo-controlled clinical trials in non-growth hormone deficient adult patients (n=522) with these conditions revealed a significant increase in mortality (42% vs. 19%) among somatropin-treated patients (doses 5.3-8 mg/day) compared to those receiving placebo .

The following important adverse reactions are also described elsewhere in the labeling:

Acute Critical Illness

Neoplasms

Impaired glucose tolerance and diabetes mellitus

Intracranial hypertension

Severe hypersensitivity

Fluid retention/Carpal tunnel syndrome

Lipoatrophy

Pancreatitis

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Tips

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Interactions

Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).