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Drospirenone, Ethinyl Estradiol and Levomefolate Calcium and Levomefolate Calcium

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Overview

What is Tydemy?

Tydemy (drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets) provides an oral contraceptive regimen consisting of 28 film-coated tablets that contain the active ingredients specified for each tablet below:

The inactive ingredients in the orange tablets are ascorbic acid, corn starch, croscarmellose sodium, ferric oxide red, ferric oxide yellow, hypromellose, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium stearate, polyethylene glycol, pregelatinized starch, talc and titanium dioxide. The light orange tablets contain 0.451 mg of levomefolate calcium. The inactive ingredients in the light orange tablets are ascorbic acid, corn starch, croscarmellose sodium, ferric oxide yellow, ferric oxide red, hypromellose, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium stearate, polyethylene glycol, pregelatinised starch, talc and titanium dioxide.

Drospirenone (2',,6,7,8,9,10,13,14,15,16)-1,3',4',6,7,8,9,10,11,12,13,14,15,16,20,21-Hexadecadydro-10,13-dimethylspirol[17-dicyclopropa [6,7:15,16] cyclopenta [a] phenanthrene-17, 2', (5')-furan] -3, 5' (2) dione is a synthetic progestational compound and has a molecular weight of 366.49 and a molecular formula of CHO.

Ethinyl estradiol 19-Nor-17α-pregna-1,3,5(10)-trien-20-yne-3,17-diol is a synthetic estrogenic compound and has a molecular weight of 296.40 and a molecular formula of CHO.

Levomefolate Calcium N-{4-[[((6S)-2-amino-3,4,5,6,7,8-hexahydro-5-methyl-4-oxo-6-pteridinyl) methyl] amino] benzoyl}-L-glutamic acid, calcium salt is a synthetic calcium salt of levomefolate (L-5-methyl-THF), which is a metabolite of vitamin B and has a molecular weight of 497.5 and a molecular formula of CHCaNO.

The structural formulas are as follows:



What does Tydemy look like?



What are the available doses of Tydemy?

Tydemy consists of 28 film-coated, biconvex tablets in the following order ():

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

Nursing mothers: Not recommended; can decrease milk production. ()

How should I use Tydemy?

Tydemy is indicated for use by women to prevent pregnancy.

Take one tablet by mouth at the same time every day. The failure rate may increase when pills are missed or taken incorrectly.

To achieve maximum contraceptive effectiveness, Tydemy must be taken as directed, in the order directed on the wallet. Single missed pills should be taken as soon as remembered.


What interacts with Tydemy?

Sorry No Records found


What are the warnings of Tydemy?

Sorry No Records found


What are the precautions of Tydemy?

Sorry No Records found


What are the side effects of Tydemy?

Sorry No records found


What should I look out for while using Tydemy?

Do not prescribe Tydemy to women who are known to have the following:

ID1035

Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptives (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs should not be used by women who are over 35 years of age and smoke


What might happen if I take too much Tydemy?

There have been no reports of serious ill effects from overdose, including ingestion by children. Overdosage may cause withdrawal bleeding in females and nausea.

DRSP is a spironolactone analogue which has anti-mineralocorticoid properties. Serum concentration of potassium and sodium, and evidence of metabolic acidosis, should be monitored in cases of overdose.

Levomefolate calcium doses of 17 mg/day (37-fold higher than the levomefolate calcium dose of Tydemy) were well tolerated after long-term treatment up to 12 weeks.


How should I store and handle Tydemy?

Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].Each Methylphenidate Hydrochloride Tablet USP 5 mg is available as a round, white unscored tablet debossed with 5 on one side and a  on the other side.                    Bottles of 100........................NDC 0406-1142-01 Each Methylphenidate Hydrochloride Tablet USP 10 mg is available as a round, white scored tablet debossed with 10 on one side of the tablet and a M on the other side.                    Bottles of 100........................NDC 0406-1144-01 Each Methylphenidate Hydrochloride Tablet USP 20 mg is available as a round, white scored tablet debossed with 20 on one side of the tablet and a  on the other side.                    Bottles of 100........................NDC 0406-1146-01 Protect from light. Dispense in tight, light-resistant container with child-resistant closure.Storage:Each Methylphenidate Hydrochloride Extended-Release Tablet USP 10 mg is available as a round, white to off-white tablet, debossed with 1423 on one side and a  on the other side.                    Bottles of 100........................NDC 0406-1445-01Each Methylphenidate Hydrochloride Extended-Release Tablet USP 20 mg is available as a round, white to off-white tablet, debossed with 1451 on one side and a  on the other side.                    Bottles of 100........................NDC 0406-1473-01Note:Dispense in tight, light-resistant container with child-resistant closure.Storage:Protect from moisture.Mallinckrodt, the “M” brand mark, the Mallinckrodt Pharmaceuticals logo and  are trademarks of a Mallinckrodt company.© 2017 Mallinckrodt.Manufactured and Distributed by:SpecGx LLCWebster Groves, MO 63119 USARev 08/2017Mallinckrodt™An electronic copy of the medication guide for Methylphenidate Hydrochloride Tablets USP can be obtained from www.mallinckrodt.com/Medguide/L20M46.pdf or by calling 1-800-778-7898 for alternate delivery options. An electronic copy of the medication guide for Methylphenidate Hydrochloride Extended-Release Tablets USP can be obtained from www.mallinckrodt.com/Medguide/L20M47.pdf or by calling 1-800-778-7898 for alternate delivery options.Each Methylphenidate Hydrochloride Tablet USP 5 mg is available as a round, white unscored tablet debossed with 5 on one side and a  on the other side.                    Bottles of 100........................NDC 0406-1142-01 Each Methylphenidate Hydrochloride Tablet USP 10 mg is available as a round, white scored tablet debossed with 10 on one side of the tablet and a M on the other side.                    Bottles of 100........................NDC 0406-1144-01 Each Methylphenidate Hydrochloride Tablet USP 20 mg is available as a round, white scored tablet debossed with 20 on one side of the tablet and a  on the other side.                    Bottles of 100........................NDC 0406-1146-01 Protect from light. Dispense in tight, light-resistant container with child-resistant closure.Storage:Each Methylphenidate Hydrochloride Extended-Release Tablet USP 10 mg is available as a round, white to off-white tablet, debossed with 1423 on one side and a  on the other side.                    Bottles of 100........................NDC 0406-1445-01Each Methylphenidate Hydrochloride Extended-Release Tablet USP 20 mg is available as a round, white to off-white tablet, debossed with 1451 on one side and a  on the other side.                    Bottles of 100........................NDC 0406-1473-01Note:Dispense in tight, light-resistant container with child-resistant closure.Storage:Protect from moisture.Mallinckrodt, the “M” brand mark, the Mallinckrodt Pharmaceuticals logo and  are trademarks of a Mallinckrodt company.© 2017 Mallinckrodt.Manufactured and Distributed by:SpecGx LLCWebster Groves, MO 63119 USARev 08/2017Mallinckrodt™An electronic copy of the medication guide for Methylphenidate Hydrochloride Tablets USP can be obtained from www.mallinckrodt.com/Medguide/L20M46.pdf or by calling 1-800-778-7898 for alternate delivery options. An electronic copy of the medication guide for Methylphenidate Hydrochloride Extended-Release Tablets USP can be obtained from www.mallinckrodt.com/Medguide/L20M47.pdf or by calling 1-800-778-7898 for alternate delivery options.Each Methylphenidate Hydrochloride Tablet USP 5 mg is available as a round, white unscored tablet debossed with 5 on one side and a  on the other side.                    Bottles of 100........................NDC 0406-1142-01 Each Methylphenidate Hydrochloride Tablet USP 10 mg is available as a round, white scored tablet debossed with 10 on one side of the tablet and a M on the other side.                    Bottles of 100........................NDC 0406-1144-01 Each Methylphenidate Hydrochloride Tablet USP 20 mg is available as a round, white scored tablet debossed with 20 on one side of the tablet and a  on the other side.                    Bottles of 100........................NDC 0406-1146-01 Protect from light. Dispense in tight, light-resistant container with child-resistant closure.Storage:Each Methylphenidate Hydrochloride Extended-Release Tablet USP 10 mg is available as a round, white to off-white tablet, debossed with 1423 on one side and a  on the other side.                    Bottles of 100........................NDC 0406-1445-01Each Methylphenidate Hydrochloride Extended-Release Tablet USP 20 mg is available as a round, white to off-white tablet, debossed with 1451 on one side and a  on the other side.                    Bottles of 100........................NDC 0406-1473-01Note:Dispense in tight, light-resistant container with child-resistant closure.Storage:Protect from moisture.Mallinckrodt, the “M” brand mark, the Mallinckrodt Pharmaceuticals logo and  are trademarks of a Mallinckrodt company.© 2017 Mallinckrodt.Manufactured and Distributed by:SpecGx LLCWebster Groves, MO 63119 USARev 08/2017Mallinckrodt™An electronic copy of the medication guide for Methylphenidate Hydrochloride Tablets USP can be obtained from www.mallinckrodt.com/Medguide/L20M46.pdf or by calling 1-800-778-7898 for alternate delivery options. An electronic copy of the medication guide for Methylphenidate Hydrochloride Extended-Release Tablets USP can be obtained from www.mallinckrodt.com/Medguide/L20M47.pdf or by calling 1-800-778-7898 for alternate delivery options.Each Methylphenidate Hydrochloride Tablet USP 5 mg is available as a round, white unscored tablet debossed with 5 on one side and a  on the other side.                    Bottles of 100........................NDC 0406-1142-01 Each Methylphenidate Hydrochloride Tablet USP 10 mg is available as a round, white scored tablet debossed with 10 on one side of the tablet and a M on the other side.                    Bottles of 100........................NDC 0406-1144-01 Each Methylphenidate Hydrochloride Tablet USP 20 mg is available as a round, white scored tablet debossed with 20 on one side of the tablet and a  on the other side.                    Bottles of 100........................NDC 0406-1146-01 Protect from light. Dispense in tight, light-resistant container with child-resistant closure.Storage:Each Methylphenidate Hydrochloride Extended-Release Tablet USP 10 mg is available as a round, white to off-white tablet, debossed with 1423 on one side and a  on the other side.                    Bottles of 100........................NDC 0406-1445-01Each Methylphenidate Hydrochloride Extended-Release Tablet USP 20 mg is available as a round, white to off-white tablet, debossed with 1451 on one side and a  on the other side.                    Bottles of 100........................NDC 0406-1473-01Note:Dispense in tight, light-resistant container with child-resistant closure.Storage:Protect from moisture.Mallinckrodt, the “M” brand mark, the Mallinckrodt Pharmaceuticals logo and  are trademarks of a Mallinckrodt company.© 2017 Mallinckrodt.Manufactured and Distributed by:SpecGx LLCWebster Groves, MO 63119 USARev 08/2017Mallinckrodt™An electronic copy of the medication guide for Methylphenidate Hydrochloride Tablets USP can be obtained from www.mallinckrodt.com/Medguide/L20M46.pdf or by calling 1-800-778-7898 for alternate delivery options. An electronic copy of the medication guide for Methylphenidate Hydrochloride Extended-Release Tablets USP can be obtained from www.mallinckrodt.com/Medguide/L20M47.pdf or by calling 1-800-778-7898 for alternate delivery options.Each Methylphenidate Hydrochloride Tablet USP 5 mg is available as a round, white unscored tablet debossed with 5 on one side and a  on the other side.                    Bottles of 100........................NDC 0406-1142-01 Each Methylphenidate Hydrochloride Tablet USP 10 mg is available as a round, white scored tablet debossed with 10 on one side of the tablet and a M on the other side.                    Bottles of 100........................NDC 0406-1144-01 Each Methylphenidate Hydrochloride Tablet USP 20 mg is available as a round, white scored tablet debossed with 20 on one side of the tablet and a  on the other side.                    Bottles of 100........................NDC 0406-1146-01 Protect from light. Dispense in tight, light-resistant container with child-resistant closure.Storage:Each Methylphenidate Hydrochloride Extended-Release Tablet USP 10 mg is available as a round, white to off-white tablet, debossed with 1423 on one side and a  on the other side.                    Bottles of 100........................NDC 0406-1445-01Each Methylphenidate Hydrochloride Extended-Release Tablet USP 20 mg is available as a round, white to off-white tablet, debossed with 1451 on one side and a  on the other side.                    Bottles of 100........................NDC 0406-1473-01Note:Dispense in tight, light-resistant container with child-resistant closure.Storage:Protect from moisture.Mallinckrodt, the “M” brand mark, the Mallinckrodt Pharmaceuticals logo and  are trademarks of a Mallinckrodt company.© 2017 Mallinckrodt.Manufactured and Distributed by:SpecGx LLCWebster Groves, MO 63119 USARev 08/2017Mallinckrodt™An electronic copy of the medication guide for Methylphenidate Hydrochloride Tablets USP can be obtained from www.mallinckrodt.com/Medguide/L20M46.pdf or by calling 1-800-778-7898 for alternate delivery options. An electronic copy of the medication guide for Methylphenidate Hydrochloride Extended-Release Tablets USP can be obtained from www.mallinckrodt.com/Medguide/L20M47.pdf or by calling 1-800-778-7898 for alternate delivery options.Each Methylphenidate Hydrochloride Tablet USP 5 mg is available as a round, white unscored tablet debossed with 5 on one side and a  on the other side.                    Bottles of 100........................NDC 0406-1142-01 Each Methylphenidate Hydrochloride Tablet USP 10 mg is available as a round, white scored tablet debossed with 10 on one side of the tablet and a M on the other side.                    Bottles of 100........................NDC 0406-1144-01 Each Methylphenidate Hydrochloride Tablet USP 20 mg is available as a round, white scored tablet debossed with 20 on one side of the tablet and a  on the other side.                    Bottles of 100........................NDC 0406-1146-01 Protect from light. Dispense in tight, light-resistant container with child-resistant closure.Storage:Each Methylphenidate Hydrochloride Extended-Release Tablet USP 10 mg is available as a round, white to off-white tablet, debossed with 1423 on one side and a  on the other side.                    Bottles of 100........................NDC 0406-1445-01Each Methylphenidate Hydrochloride Extended-Release Tablet USP 20 mg is available as a round, white to off-white tablet, debossed with 1451 on one side and a  on the other side.                    Bottles of 100........................NDC 0406-1473-01Note:Dispense in tight, light-resistant container with child-resistant closure.Storage:Protect from moisture.Mallinckrodt, the “M” brand mark, the Mallinckrodt Pharmaceuticals logo and  are trademarks of a Mallinckrodt company.© 2017 Mallinckrodt.Manufactured and Distributed by:SpecGx LLCWebster Groves, MO 63119 USARev 08/2017Mallinckrodt™An electronic copy of the medication guide for Methylphenidate Hydrochloride Tablets USP can be obtained from www.mallinckrodt.com/Medguide/L20M46.pdf or by calling 1-800-778-7898 for alternate delivery options. An electronic copy of the medication guide for Methylphenidate Hydrochloride Extended-Release Tablets USP can be obtained from www.mallinckrodt.com/Medguide/L20M47.pdf or by calling 1-800-778-7898 for alternate delivery options.Each Methylphenidate Hydrochloride Tablet USP 5 mg is available as a round, white unscored tablet debossed with 5 on one side and a  on the other side.                    Bottles of 100........................NDC 0406-1142-01 Each Methylphenidate Hydrochloride Tablet USP 10 mg is available as a round, white scored tablet debossed with 10 on one side of the tablet and a M on the other side.                    Bottles of 100........................NDC 0406-1144-01 Each Methylphenidate Hydrochloride Tablet USP 20 mg is available as a round, white scored tablet debossed with 20 on one side of the tablet and a  on the other side.                    Bottles of 100........................NDC 0406-1146-01 Protect from light. Dispense in tight, light-resistant container with child-resistant closure.Storage:Each Methylphenidate Hydrochloride Extended-Release Tablet USP 10 mg is available as a round, white to off-white tablet, debossed with 1423 on one side and a  on the other side.                    Bottles of 100........................NDC 0406-1445-01Each Methylphenidate Hydrochloride Extended-Release Tablet USP 20 mg is available as a round, white to off-white tablet, debossed with 1451 on one side and a  on the other side.                    Bottles of 100........................NDC 0406-1473-01Note:Dispense in tight, light-resistant container with child-resistant closure.Storage:Protect from moisture.Mallinckrodt, the “M” brand mark, the Mallinckrodt Pharmaceuticals logo and  are trademarks of a Mallinckrodt company.© 2017 Mallinckrodt.Manufactured and Distributed by:SpecGx LLCWebster Groves, MO 63119 USARev 08/2017Mallinckrodt™An electronic copy of the medication guide for Methylphenidate Hydrochloride Tablets USP can be obtained from www.mallinckrodt.com/Medguide/L20M46.pdf or by calling 1-800-778-7898 for alternate delivery options. An electronic copy of the medication guide for Methylphenidate Hydrochloride Extended-Release Tablets USP can be obtained from www.mallinckrodt.com/Medguide/L20M47.pdf or by calling 1-800-778-7898 for alternate delivery options.Each Methylphenidate Hydrochloride Tablet USP 5 mg is available as a round, white unscored tablet debossed with 5 on one side and a  on the other side.                    Bottles of 100........................NDC 0406-1142-01 Each Methylphenidate Hydrochloride Tablet USP 10 mg is available as a round, white scored tablet debossed with 10 on one side of the tablet and a M on the other side.                    Bottles of 100........................NDC 0406-1144-01 Each Methylphenidate Hydrochloride Tablet USP 20 mg is available as a round, white scored tablet debossed with 20 on one side of the tablet and a  on the other side.                    Bottles of 100........................NDC 0406-1146-01 Protect from light. Dispense in tight, light-resistant container with child-resistant closure.Storage:Each Methylphenidate Hydrochloride Extended-Release Tablet USP 10 mg is available as a round, white to off-white tablet, debossed with 1423 on one side and a  on the other side.                    Bottles of 100........................NDC 0406-1445-01Each Methylphenidate Hydrochloride Extended-Release Tablet USP 20 mg is available as a round, white to off-white tablet, debossed with 1451 on one side and a  on the other side.                    Bottles of 100........................NDC 0406-1473-01Note:Dispense in tight, light-resistant container with child-resistant closure.Storage:Protect from moisture.Mallinckrodt, the “M” brand mark, the Mallinckrodt Pharmaceuticals logo and  are trademarks of a Mallinckrodt company.© 2017 Mallinckrodt.Manufactured and Distributed by:SpecGx LLCWebster Groves, MO 63119 USARev 08/2017Mallinckrodt™An electronic copy of the medication guide for Methylphenidate Hydrochloride Tablets USP can be obtained from www.mallinckrodt.com/Medguide/L20M46.pdf or by calling 1-800-778-7898 for alternate delivery options. An electronic copy of the medication guide for Methylphenidate Hydrochloride Extended-Release Tablets USP can be obtained from www.mallinckrodt.com/Medguide/L20M47.pdf or by calling 1-800-778-7898 for alternate delivery options.Each Methylphenidate Hydrochloride Tablet USP 5 mg is available as a round, white unscored tablet debossed with 5 on one side and a  on the other side.                    Bottles of 100........................NDC 0406-1142-01 Each Methylphenidate Hydrochloride Tablet USP 10 mg is available as a round, white scored tablet debossed with 10 on one side of the tablet and a M on the other side.                    Bottles of 100........................NDC 0406-1144-01 Each Methylphenidate Hydrochloride Tablet USP 20 mg is available as a round, white scored tablet debossed with 20 on one side of the tablet and a  on the other side.                    Bottles of 100........................NDC 0406-1146-01 Protect from light. Dispense in tight, light-resistant container with child-resistant closure.Storage:Each Methylphenidate Hydrochloride Extended-Release Tablet USP 10 mg is available as a round, white to off-white tablet, debossed with 1423 on one side and a  on the other side.                    Bottles of 100........................NDC 0406-1445-01Each Methylphenidate Hydrochloride Extended-Release Tablet USP 20 mg is available as a round, white to off-white tablet, debossed with 1451 on one side and a  on the other side.                    Bottles of 100........................NDC 0406-1473-01Note:Dispense in tight, light-resistant container with child-resistant closure.Storage:Protect from moisture.Mallinckrodt, the “M” brand mark, the Mallinckrodt Pharmaceuticals logo and  are trademarks of a Mallinckrodt company.© 2017 Mallinckrodt.Manufactured and Distributed by:SpecGx LLCWebster Groves, MO 63119 USARev 08/2017Mallinckrodt™An electronic copy of the medication guide for Methylphenidate Hydrochloride Tablets USP can be obtained from www.mallinckrodt.com/Medguide/L20M46.pdf or by calling 1-800-778-7898 for alternate delivery options. An electronic copy of the medication guide for Methylphenidate Hydrochloride Extended-Release Tablets USP can be obtained from www.mallinckrodt.com/Medguide/L20M47.pdf or by calling 1-800-778-7898 for alternate delivery options.Each Methylphenidate Hydrochloride Tablet USP 5 mg is available as a round, white unscored tablet debossed with 5 on one side and a  on the other side.                    Bottles of 100........................NDC 0406-1142-01 Each Methylphenidate Hydrochloride Tablet USP 10 mg is available as a round, white scored tablet debossed with 10 on one side of the tablet and a M on the other side.                    Bottles of 100........................NDC 0406-1144-01 Each Methylphenidate Hydrochloride Tablet USP 20 mg is available as a round, white scored tablet debossed with 20 on one side of the tablet and a  on the other side.                    Bottles of 100........................NDC 0406-1146-01 Protect from light. Dispense in tight, light-resistant container with child-resistant closure.Storage:Each Methylphenidate Hydrochloride Extended-Release Tablet USP 10 mg is available as a round, white to off-white tablet, debossed with 1423 on one side and a  on the other side.                    Bottles of 100........................NDC 0406-1445-01Each Methylphenidate Hydrochloride Extended-Release Tablet USP 20 mg is available as a round, white to off-white tablet, debossed with 1451 on one side and a  on the other side.                    Bottles of 100........................NDC 0406-1473-01Note:Dispense in tight, light-resistant container with child-resistant closure.Storage:Protect from moisture.Mallinckrodt, the “M” brand mark, the Mallinckrodt Pharmaceuticals logo and  are trademarks of a Mallinckrodt company.© 2017 Mallinckrodt.Manufactured and Distributed by:SpecGx LLCWebster Groves, MO 63119 USARev 08/2017Mallinckrodt™An electronic copy of the medication guide for Methylphenidate Hydrochloride Tablets USP can be obtained from www.mallinckrodt.com/Medguide/L20M46.pdf or by calling 1-800-778-7898 for alternate delivery options. An electronic copy of the medication guide for Methylphenidate Hydrochloride Extended-Release Tablets USP can be obtained from www.mallinckrodt.com/Medguide/L20M47.pdf or by calling 1-800-778-7898 for alternate delivery options.Each Methylphenidate Hydrochloride Tablet USP 5 mg is available as a round, white unscored tablet debossed with 5 on one side and a  on the other side.                    Bottles of 100........................NDC 0406-1142-01 Each Methylphenidate Hydrochloride Tablet USP 10 mg is available as a round, white scored tablet debossed with 10 on one side of the tablet and a M on the other side.                    Bottles of 100........................NDC 0406-1144-01 Each Methylphenidate Hydrochloride Tablet USP 20 mg is available as a round, white scored tablet debossed with 20 on one side of the tablet and a  on the other side.                    Bottles of 100........................NDC 0406-1146-01 Protect from light. Dispense in tight, light-resistant container with child-resistant closure.Storage:Each Methylphenidate Hydrochloride Extended-Release Tablet USP 10 mg is available as a round, white to off-white tablet, debossed with 1423 on one side and a  on the other side.                    Bottles of 100........................NDC 0406-1445-01Each Methylphenidate Hydrochloride Extended-Release Tablet USP 20 mg is available as a round, white to off-white tablet, debossed with 1451 on one side and a  on the other side.                    Bottles of 100........................NDC 0406-1473-01Note:Dispense in tight, light-resistant container with child-resistant closure.Storage:Protect from moisture.Mallinckrodt, the “M” brand mark, the Mallinckrodt Pharmaceuticals logo and  are trademarks of a Mallinckrodt company.© 2017 Mallinckrodt.Manufactured and Distributed by:SpecGx LLCWebster Groves, MO 63119 USARev 08/2017Mallinckrodt™An electronic copy of the medication guide for Methylphenidate Hydrochloride Tablets USP can be obtained from www.mallinckrodt.com/Medguide/L20M46.pdf or by calling 1-800-778-7898 for alternate delivery options. An electronic copy of the medication guide for Methylphenidate Hydrochloride Extended-Release Tablets USP can be obtained from www.mallinckrodt.com/Medguide/L20M47.pdf or by calling 1-800-778-7898 for alternate delivery options.Each Methylphenidate Hydrochloride Tablet USP 5 mg is available as a round, white unscored tablet debossed with 5 on one side and a  on the other side.                    Bottles of 100........................NDC 0406-1142-01 Each Methylphenidate Hydrochloride Tablet USP 10 mg is available as a round, white scored tablet debossed with 10 on one side of the tablet and a M on the other side.                    Bottles of 100........................NDC 0406-1144-01 Each Methylphenidate Hydrochloride Tablet USP 20 mg is available as a round, white scored tablet debossed with 20 on one side of the tablet and a  on the other side.                    Bottles of 100........................NDC 0406-1146-01 Protect from light. Dispense in tight, light-resistant container with child-resistant closure.Storage:Each Methylphenidate Hydrochloride Extended-Release Tablet USP 10 mg is available as a round, white to off-white tablet, debossed with 1423 on one side and a  on the other side.                    Bottles of 100........................NDC 0406-1445-01Each Methylphenidate Hydrochloride Extended-Release Tablet USP 20 mg is available as a round, white to off-white tablet, debossed with 1451 on one side and a  on the other side.                    Bottles of 100........................NDC 0406-1473-01Note:Dispense in tight, light-resistant container with child-resistant closure.Storage:Protect from moisture.Mallinckrodt, the “M” brand mark, the Mallinckrodt Pharmaceuticals logo and  are trademarks of a Mallinckrodt company.© 2017 Mallinckrodt.Manufactured and Distributed by:SpecGx LLCWebster Groves, MO 63119 USARev 08/2017Mallinckrodt™An electronic copy of the medication guide for Methylphenidate Hydrochloride Tablets USP can be obtained from www.mallinckrodt.com/Medguide/L20M46.pdf or by calling 1-800-778-7898 for alternate delivery options. An electronic copy of the medication guide for Methylphenidate Hydrochloride Extended-Release Tablets USP can be obtained from www.mallinckrodt.com/Medguide/L20M47.pdf or by calling 1-800-778-7898 for alternate delivery options.Each Methylphenidate Hydrochloride Tablet USP 5 mg is available as a round, white unscored tablet debossed with 5 on one side and a  on the other side.                    Bottles of 100........................NDC 0406-1142-01 Each Methylphenidate Hydrochloride Tablet USP 10 mg is available as a round, white scored tablet debossed with 10 on one side of the tablet and a M on the other side.                    Bottles of 100........................NDC 0406-1144-01 Each Methylphenidate Hydrochloride Tablet USP 20 mg is available as a round, white scored tablet debossed with 20 on one side of the tablet and a  on the other side.                    Bottles of 100........................NDC 0406-1146-01 Protect from light. Dispense in tight, light-resistant container with child-resistant closure.Storage:Each Methylphenidate Hydrochloride Extended-Release Tablet USP 10 mg is available as a round, white to off-white tablet, debossed with 1423 on one side and a  on the other side.                    Bottles of 100........................NDC 0406-1445-01Each Methylphenidate Hydrochloride Extended-Release Tablet USP 20 mg is available as a round, white to off-white tablet, debossed with 1451 on one side and a  on the other side.                    Bottles of 100........................NDC 0406-1473-01Note:Dispense in tight, light-resistant container with child-resistant closure.Storage:Protect from moisture.Mallinckrodt, the “M” brand mark, the Mallinckrodt Pharmaceuticals logo and  are trademarks of a Mallinckrodt company.© 2017 Mallinckrodt.Manufactured and Distributed by:SpecGx LLCWebster Groves, MO 63119 USARev 08/2017Mallinckrodt™An electronic copy of the medication guide for Methylphenidate Hydrochloride Tablets USP can be obtained from www.mallinckrodt.com/Medguide/L20M46.pdf or by calling 1-800-778-7898 for alternate delivery options. An electronic copy of the medication guide for Methylphenidate Hydrochloride Extended-Release Tablets USP can be obtained from www.mallinckrodt.com/Medguide/L20M47.pdf or by calling 1-800-778-7898 for alternate delivery options.Each Methylphenidate Hydrochloride Tablet USP 5 mg is available as a round, white unscored tablet debossed with 5 on one side and a  on the other side.                    Bottles of 100........................NDC 0406-1142-01 Each Methylphenidate Hydrochloride Tablet USP 10 mg is available as a round, white scored tablet debossed with 10 on one side of the tablet and a M on the other side.                    Bottles of 100........................NDC 0406-1144-01 Each Methylphenidate Hydrochloride Tablet USP 20 mg is available as a round, white scored tablet debossed with 20 on one side of the tablet and a  on the other side.                    Bottles of 100........................NDC 0406-1146-01 Protect from light. Dispense in tight, light-resistant container with child-resistant closure.Storage:Each Methylphenidate Hydrochloride Extended-Release Tablet USP 10 mg is available as a round, white to off-white tablet, debossed with 1423 on one side and a  on the other side.                    Bottles of 100........................NDC 0406-1445-01Each Methylphenidate Hydrochloride Extended-Release Tablet USP 20 mg is available as a round, white to off-white tablet, debossed with 1451 on one side and a  on the other side.                    Bottles of 100........................NDC 0406-1473-01Note:Dispense in tight, light-resistant container with child-resistant closure.Storage:Protect from moisture.Mallinckrodt, the “M” brand mark, the Mallinckrodt Pharmaceuticals logo and  are trademarks of a Mallinckrodt company.© 2017 Mallinckrodt.Manufactured and Distributed by:SpecGx LLCWebster Groves, MO 63119 USARev 08/2017Mallinckrodt™An electronic copy of the medication guide for Methylphenidate Hydrochloride Tablets USP can be obtained from www.mallinckrodt.com/Medguide/L20M46.pdf or by calling 1-800-778-7898 for alternate delivery options. An electronic copy of the medication guide for Methylphenidate Hydrochloride Extended-Release Tablets USP can be obtained from www.mallinckrodt.com/Medguide/L20M47.pdf or by calling 1-800-778-7898 for alternate delivery options.Each Methylphenidate Hydrochloride Tablet USP 5 mg is available as a round, white unscored tablet debossed with 5 on one side and a  on the other side.                    Bottles of 100........................NDC 0406-1142-01 Each Methylphenidate Hydrochloride Tablet USP 10 mg is available as a round, white scored tablet debossed with 10 on one side of the tablet and a M on the other side.                    Bottles of 100........................NDC 0406-1144-01 Each Methylphenidate Hydrochloride Tablet USP 20 mg is available as a round, white scored tablet debossed with 20 on one side of the tablet and a  on the other side.                    Bottles of 100........................NDC 0406-1146-01 Protect from light. Dispense in tight, light-resistant container with child-resistant closure.Storage:Each Methylphenidate Hydrochloride Extended-Release Tablet USP 10 mg is available as a round, white to off-white tablet, debossed with 1423 on one side and a  on the other side.                    Bottles of 100........................NDC 0406-1445-01Each Methylphenidate Hydrochloride Extended-Release Tablet USP 20 mg is available as a round, white to off-white tablet, debossed with 1451 on one side and a  on the other side.                    Bottles of 100........................NDC 0406-1473-01Note:Dispense in tight, light-resistant container with child-resistant closure.Storage:Protect from moisture.Mallinckrodt, the “M” brand mark, the Mallinckrodt Pharmaceuticals logo and  are trademarks of a Mallinckrodt company.© 2017 Mallinckrodt.Manufactured and Distributed by:SpecGx LLCWebster Groves, MO 63119 USARev 08/2017Mallinckrodt™An electronic copy of the medication guide for Methylphenidate Hydrochloride Tablets USP can be obtained from www.mallinckrodt.com/Medguide/L20M46.pdf or by calling 1-800-778-7898 for alternate delivery options. An electronic copy of the medication guide for Methylphenidate Hydrochloride Extended-Release Tablets USP can be obtained from www.mallinckrodt.com/Medguide/L20M47.pdf or by calling 1-800-778-7898 for alternate delivery options.Each Methylphenidate Hydrochloride Tablet USP 5 mg is available as a round, white unscored tablet debossed with 5 on one side and a  on the other side.                    Bottles of 100........................NDC 0406-1142-01 Each Methylphenidate Hydrochloride Tablet USP 10 mg is available as a round, white scored tablet debossed with 10 on one side of the tablet and a M on the other side.                    Bottles of 100........................NDC 0406-1144-01 Each Methylphenidate Hydrochloride Tablet USP 20 mg is available as a round, white scored tablet debossed with 20 on one side of the tablet and a  on the other side.                    Bottles of 100........................NDC 0406-1146-01 Protect from light. Dispense in tight, light-resistant container with child-resistant closure.Storage:Each Methylphenidate Hydrochloride Extended-Release Tablet USP 10 mg is available as a round, white to off-white tablet, debossed with 1423 on one side and a  on the other side.                    Bottles of 100........................NDC 0406-1445-01Each Methylphenidate Hydrochloride Extended-Release Tablet USP 20 mg is available as a round, white to off-white tablet, debossed with 1451 on one side and a  on the other side.                    Bottles of 100........................NDC 0406-1473-01Note:Dispense in tight, light-resistant container with child-resistant closure.Storage:Protect from moisture.Mallinckrodt, the “M” brand mark, the Mallinckrodt Pharmaceuticals logo and  are trademarks of a Mallinckrodt company.© 2017 Mallinckrodt.Manufactured and Distributed by:SpecGx LLCWebster Groves, MO 63119 USARev 08/2017Mallinckrodt™An electronic copy of the medication guide for Methylphenidate Hydrochloride Tablets USP can be obtained from www.mallinckrodt.com/Medguide/L20M46.pdf or by calling 1-800-778-7898 for alternate delivery options. An electronic copy of the medication guide for Methylphenidate Hydrochloride Extended-Release Tablets USP can be obtained from www.mallinckrodt.com/Medguide/L20M47.pdf or by calling 1-800-778-7898 for alternate delivery options.Each Methylphenidate Hydrochloride Tablet USP 5 mg is available as a round, white unscored tablet debossed with 5 on one side and a  on the other side.                    Bottles of 100........................NDC 0406-1142-01 Each Methylphenidate Hydrochloride Tablet USP 10 mg is available as a round, white scored tablet debossed with 10 on one side of the tablet and a M on the other side.                    Bottles of 100........................NDC 0406-1144-01 Each Methylphenidate Hydrochloride Tablet USP 20 mg is available as a round, white scored tablet debossed with 20 on one side of the tablet and a  on the other side.                    Bottles of 100........................NDC 0406-1146-01 Protect from light. Dispense in tight, light-resistant container with child-resistant closure.Storage:Each Methylphenidate Hydrochloride Extended-Release Tablet USP 10 mg is available as a round, white to off-white tablet, debossed with 1423 on one side and a  on the other side.                    Bottles of 100........................NDC 0406-1445-01Each Methylphenidate Hydrochloride Extended-Release Tablet USP 20 mg is available as a round, white to off-white tablet, debossed with 1451 on one side and a  on the other side.                    Bottles of 100........................NDC 0406-1473-01Note:Dispense in tight, light-resistant container with child-resistant closure.Storage:Protect from moisture.Mallinckrodt, the “M” brand mark, the Mallinckrodt Pharmaceuticals logo and  are trademarks of a Mallinckrodt company.© 2017 Mallinckrodt.Manufactured and Distributed by:SpecGx LLCWebster Groves, MO 63119 USARev 08/2017Mallinckrodt™An electronic copy of the medication guide for Methylphenidate Hydrochloride Tablets USP can be obtained from www.mallinckrodt.com/Medguide/L20M46.pdf or by calling 1-800-778-7898 for alternate delivery options. An electronic copy of the medication guide for Methylphenidate Hydrochloride Extended-Release Tablets USP can be obtained from www.mallinckrodt.com/Medguide/L20M47.pdf or by calling 1-800-778-7898 for alternate delivery options.Each Methylphenidate Hydrochloride Tablet USP 5 mg is available as a round, white unscored tablet debossed with 5 on one side and a  on the other side.                    Bottles of 100........................NDC 0406-1142-01 Each Methylphenidate Hydrochloride Tablet USP 10 mg is available as a round, white scored tablet debossed with 10 on one side of the tablet and a M on the other side.                    Bottles of 100........................NDC 0406-1144-01 Each Methylphenidate Hydrochloride Tablet USP 20 mg is available as a round, white scored tablet debossed with 20 on one side of the tablet and a  on the other side.                    Bottles of 100........................NDC 0406-1146-01 Protect from light. Dispense in tight, light-resistant container with child-resistant closure.Storage:Each Methylphenidate Hydrochloride Extended-Release Tablet USP 10 mg is available as a round, white to off-white tablet, debossed with 1423 on one side and a  on the other side.                    Bottles of 100........................NDC 0406-1445-01Each Methylphenidate Hydrochloride Extended-Release Tablet USP 20 mg is available as a round, white to off-white tablet, debossed with 1451 on one side and a  on the other side.                    Bottles of 100........................NDC 0406-1473-01Note:Dispense in tight, light-resistant container with child-resistant closure.Storage:Protect from moisture.Mallinckrodt, the “M” brand mark, the Mallinckrodt Pharmaceuticals logo and  are trademarks of a Mallinckrodt company.© 2017 Mallinckrodt.Manufactured and Distributed by:SpecGx LLCWebster Groves, MO 63119 USARev 08/2017Mallinckrodt™An electronic copy of the medication guide for Methylphenidate Hydrochloride Tablets USP can be obtained from www.mallinckrodt.com/Medguide/L20M46.pdf or by calling 1-800-778-7898 for alternate delivery options. An electronic copy of the medication guide for Methylphenidate Hydrochloride Extended-Release Tablets USP can be obtained from www.mallinckrodt.com/Medguide/L20M47.pdf or by calling 1-800-778-7898 for alternate delivery options.Each Methylphenidate Hydrochloride Tablet USP 5 mg is available as a round, white unscored tablet debossed with 5 on one side and a  on the other side.                    Bottles of 100........................NDC 0406-1142-01 Each Methylphenidate Hydrochloride Tablet USP 10 mg is available as a round, white scored tablet debossed with 10 on one side of the tablet and a M on the other side.                    Bottles of 100........................NDC 0406-1144-01 Each Methylphenidate Hydrochloride Tablet USP 20 mg is available as a round, white scored tablet debossed with 20 on one side of the tablet and a  on the other side.                    Bottles of 100........................NDC 0406-1146-01 Protect from light. Dispense in tight, light-resistant container with child-resistant closure.Storage:Each Methylphenidate Hydrochloride Extended-Release Tablet USP 10 mg is available as a round, white to off-white tablet, debossed with 1423 on one side and a  on the other side.                    Bottles of 100........................NDC 0406-1445-01Each Methylphenidate Hydrochloride Extended-Release Tablet USP 20 mg is available as a round, white to off-white tablet, debossed with 1451 on one side and a  on the other side.                    Bottles of 100........................NDC 0406-1473-01Note:Dispense in tight, light-resistant container with child-resistant closure.Storage:Protect from moisture.Mallinckrodt, the “M” brand mark, the Mallinckrodt Pharmaceuticals logo and  are trademarks of a Mallinckrodt company.© 2017 Mallinckrodt.Manufactured and Distributed by:SpecGx LLCWebster Groves, MO 63119 USARev 08/2017Mallinckrodt™An electronic copy of the medication guide for Methylphenidate Hydrochloride Tablets USP can be obtained from www.mallinckrodt.com/Medguide/L20M46.pdf or by calling 1-800-778-7898 for alternate delivery options. An electronic copy of the medication guide for Methylphenidate Hydrochloride Extended-Release Tablets USP can be obtained from www.mallinckrodt.com/Medguide/L20M47.pdf or by calling 1-800-778-7898 for alternate delivery options.Each Methylphenidate Hydrochloride Tablet USP 5 mg is available as a round, white unscored tablet debossed with 5 on one side and a  on the other side.                    Bottles of 100........................NDC 0406-1142-01 Each Methylphenidate Hydrochloride Tablet USP 10 mg is available as a round, white scored tablet debossed with 10 on one side of the tablet and a M on the other side.                    Bottles of 100........................NDC 0406-1144-01 Each Methylphenidate Hydrochloride Tablet USP 20 mg is available as a round, white scored tablet debossed with 20 on one side of the tablet and a  on the other side.                    Bottles of 100........................NDC 0406-1146-01 Protect from light. Dispense in tight, light-resistant container with child-resistant closure.Storage:Each Methylphenidate Hydrochloride Extended-Release Tablet USP 10 mg is available as a round, white to off-white tablet, debossed with 1423 on one side and a  on the other side.                    Bottles of 100........................NDC 0406-1445-01Each Methylphenidate Hydrochloride Extended-Release Tablet USP 20 mg is available as a round, white to off-white tablet, debossed with 1451 on one side and a  on the other side.                    Bottles of 100........................NDC 0406-1473-01Note:Dispense in tight, light-resistant container with child-resistant closure.Storage:Protect from moisture.Mallinckrodt, the “M” brand mark, the Mallinckrodt Pharmaceuticals logo and  are trademarks of a Mallinckrodt company.© 2017 Mallinckrodt.Manufactured and Distributed by:SpecGx LLCWebster Groves, MO 63119 USARev 08/2017Mallinckrodt™An electronic copy of the medication guide for Methylphenidate Hydrochloride Tablets USP can be obtained from www.mallinckrodt.com/Medguide/L20M46.pdf or by calling 1-800-778-7898 for alternate delivery options. An electronic copy of the medication guide for Methylphenidate Hydrochloride Extended-Release Tablets USP can be obtained from www.mallinckrodt.com/Medguide/L20M47.pdf or by calling 1-800-778-7898 for alternate delivery options.Each Methylphenidate Hydrochloride Tablet USP 5 mg is available as a round, white unscored tablet debossed with 5 on one side and a  on the other side.                    Bottles of 100........................NDC 0406-1142-01 Each Methylphenidate Hydrochloride Tablet USP 10 mg is available as a round, white scored tablet debossed with 10 on one side of the tablet and a M on the other side.                    Bottles of 100........................NDC 0406-1144-01 Each Methylphenidate Hydrochloride Tablet USP 20 mg is available as a round, white scored tablet debossed with 20 on one side of the tablet and a  on the other side.                    Bottles of 100........................NDC 0406-1146-01 Protect from light. Dispense in tight, light-resistant container with child-resistant closure.Storage:Each Methylphenidate Hydrochloride Extended-Release Tablet USP 10 mg is available as a round, white to off-white tablet, debossed with 1423 on one side and a  on the other side.                    Bottles of 100........................NDC 0406-1445-01Each Methylphenidate Hydrochloride Extended-Release Tablet USP 20 mg is available as a round, white to off-white tablet, debossed with 1451 on one side and a  on the other side.                    Bottles of 100........................NDC 0406-1473-01Note:Dispense in tight, light-resistant container with child-resistant closure.Storage:Protect from moisture.Mallinckrodt, the “M” brand mark, the Mallinckrodt Pharmaceuticals logo and  are trademarks of a Mallinckrodt company.© 2017 Mallinckrodt.Manufactured and Distributed by:SpecGx LLCWebster Groves, MO 63119 USARev 08/2017Mallinckrodt™An electronic copy of the medication guide for Methylphenidate Hydrochloride Tablets USP can be obtained from www.mallinckrodt.com/Medguide/L20M46.pdf or by calling 1-800-778-7898 for alternate delivery options. An electronic copy of the medication guide for Methylphenidate Hydrochloride Extended-Release Tablets USP can be obtained from www.mallinckrodt.com/Medguide/L20M47.pdf or by calling 1-800-778-7898 for alternate delivery options.Each Methylphenidate Hydrochloride Tablet USP 5 mg is available as a round, white unscored tablet debossed with 5 on one side and a  on the other side.                    Bottles of 100........................NDC 0406-1142-01 Each Methylphenidate Hydrochloride Tablet USP 10 mg is available as a round, white scored tablet debossed with 10 on one side of the tablet and a M on the other side.                    Bottles of 100........................NDC 0406-1144-01 Each Methylphenidate Hydrochloride Tablet USP 20 mg is available as a round, white scored tablet debossed with 20 on one side of the tablet and a  on the other side.                    Bottles of 100........................NDC 0406-1146-01 Protect from light. Dispense in tight, light-resistant container with child-resistant closure.Storage:Each Methylphenidate Hydrochloride Extended-Release Tablet USP 10 mg is available as a round, white to off-white tablet, debossed with 1423 on one side and a  on the other side.                    Bottles of 100........................NDC 0406-1445-01Each Methylphenidate Hydrochloride Extended-Release Tablet USP 20 mg is available as a round, white to off-white tablet, debossed with 1451 on one side and a  on the other side.                    Bottles of 100........................NDC 0406-1473-01Note:Dispense in tight, light-resistant container with child-resistant closure.Storage:Protect from moisture.Mallinckrodt, the “M” brand mark, the Mallinckrodt Pharmaceuticals logo and  are trademarks of a Mallinckrodt company.© 2017 Mallinckrodt.Manufactured and Distributed by:SpecGx LLCWebster Groves, MO 63119 USARev 08/2017Mallinckrodt™An electronic copy of the medication guide for Methylphenidate Hydrochloride Tablets USP can be obtained from www.mallinckrodt.com/Medguide/L20M46.pdf or by calling 1-800-778-7898 for alternate delivery options. An electronic copy of the medication guide for Methylphenidate Hydrochloride Extended-Release Tablets USP can be obtained from www.mallinckrodt.com/Medguide/L20M47.pdf or by calling 1-800-778-7898 for alternate delivery options.Each Methylphenidate Hydrochloride Tablet USP 5 mg is available as a round, white unscored tablet debossed with 5 on one side and a  on the other side.                    Bottles of 100........................NDC 0406-1142-01 Each Methylphenidate Hydrochloride Tablet USP 10 mg is available as a round, white scored tablet debossed with 10 on one side of the tablet and a M on the other side.                    Bottles of 100........................NDC 0406-1144-01 Each Methylphenidate Hydrochloride Tablet USP 20 mg is available as a round, white scored tablet debossed with 20 on one side of the tablet and a  on the other side.                    Bottles of 100........................NDC 0406-1146-01 Protect from light. Dispense in tight, light-resistant container with child-resistant closure.Storage:Each Methylphenidate Hydrochloride Extended-Release Tablet USP 10 mg is available as a round, white to off-white tablet, debossed with 1423 on one side and a  on the other side.                    Bottles of 100........................NDC 0406-1445-01Each Methylphenidate Hydrochloride Extended-Release Tablet USP 20 mg is available as a round, white to off-white tablet, debossed with 1451 on one side and a  on the other side.                    Bottles of 100........................NDC 0406-1473-01Note:Dispense in tight, light-resistant container with child-resistant closure.Storage:Protect from moisture.Mallinckrodt, the “M” brand mark, the Mallinckrodt Pharmaceuticals logo and  are trademarks of a Mallinckrodt company.© 2017 Mallinckrodt.Manufactured and Distributed by:SpecGx LLCWebster Groves, MO 63119 USARev 08/2017Mallinckrodt™An electronic copy of the medication guide for Methylphenidate Hydrochloride Tablets USP can be obtained from www.mallinckrodt.com/Medguide/L20M46.pdf or by calling 1-800-778-7898 for alternate delivery options. An electronic copy of the medication guide for Methylphenidate Hydrochloride Extended-Release Tablets USP can be obtained from www.mallinckrodt.com/Medguide/L20M47.pdf or by calling 1-800-778-7898 for alternate delivery options.Each Methylphenidate Hydrochloride Tablet USP 5 mg is available as a round, white unscored tablet debossed with 5 on one side and a  on the other side.                    Bottles of 100........................NDC 0406-1142-01 Each Methylphenidate Hydrochloride Tablet USP 10 mg is available as a round, white scored tablet debossed with 10 on one side of the tablet and a M on the other side.                    Bottles of 100........................NDC 0406-1144-01 Each Methylphenidate Hydrochloride Tablet USP 20 mg is available as a round, white scored tablet debossed with 20 on one side of the tablet and a  on the other side.                    Bottles of 100........................NDC 0406-1146-01 Protect from light. Dispense in tight, light-resistant container with child-resistant closure.Storage:Each Methylphenidate Hydrochloride Extended-Release Tablet USP 10 mg is available as a round, white to off-white tablet, debossed with 1423 on one side and a  on the other side.                    Bottles of 100........................NDC 0406-1445-01Each Methylphenidate Hydrochloride Extended-Release Tablet USP 20 mg is available as a round, white to off-white tablet, debossed with 1451 on one side and a  on the other side.                    Bottles of 100........................NDC 0406-1473-01Note:Dispense in tight, light-resistant container with child-resistant closure.Storage:Protect from moisture.Mallinckrodt, the “M” brand mark, the Mallinckrodt Pharmaceuticals logo and  are trademarks of a Mallinckrodt company.© 2017 Mallinckrodt.Manufactured and Distributed by:SpecGx LLCWebster Groves, MO 63119 USARev 08/2017Mallinckrodt™An electronic copy of the medication guide for Methylphenidate Hydrochloride Tablets USP can be obtained from www.mallinckrodt.com/Medguide/L20M46.pdf or by calling 1-800-778-7898 for alternate delivery options. An electronic copy of the medication guide for Methylphenidate Hydrochloride Extended-Release Tablets USP can be obtained from www.mallinckrodt.com/Medguide/L20M47.pdf or by calling 1-800-778-7898 for alternate delivery options.Each Methylphenidate Hydrochloride Tablet USP 5 mg is available as a round, white unscored tablet debossed with 5 on one side and a  on the other side.                    Bottles of 100........................NDC 0406-1142-01 Each Methylphenidate Hydrochloride Tablet USP 10 mg is available as a round, white scored tablet debossed with 10 on one side of the tablet and a M on the other side.                    Bottles of 100........................NDC 0406-1144-01 Each Methylphenidate Hydrochloride Tablet USP 20 mg is available as a round, white scored tablet debossed with 20 on one side of the tablet and a  on the other side.                    Bottles of 100........................NDC 0406-1146-01 Protect from light. Dispense in tight, light-resistant container with child-resistant closure.Storage:Each Methylphenidate Hydrochloride Extended-Release Tablet USP 10 mg is available as a round, white to off-white tablet, debossed with 1423 on one side and a  on the other side.                    Bottles of 100........................NDC 0406-1445-01Each Methylphenidate Hydrochloride Extended-Release Tablet USP 20 mg is available as a round, white to off-white tablet, debossed with 1451 on one side and a  on the other side.                    Bottles of 100........................NDC 0406-1473-01Note:Dispense in tight, light-resistant container with child-resistant closure.Storage:Protect from moisture.Mallinckrodt, the “M” brand mark, the Mallinckrodt Pharmaceuticals logo and  are trademarks of a Mallinckrodt company.© 2017 Mallinckrodt.Manufactured and Distributed by:SpecGx LLCWebster Groves, MO 63119 USARev 08/2017Mallinckrodt™An electronic copy of the medication guide for Methylphenidate Hydrochloride Tablets USP can be obtained from www.mallinckrodt.com/Medguide/L20M46.pdf or by calling 1-800-778-7898 for alternate delivery options. An electronic copy of the medication guide for Methylphenidate Hydrochloride Extended-Release Tablets USP can be obtained from www.mallinckrodt.com/Medguide/L20M47.pdf or by calling 1-800-778-7898 for alternate delivery options.


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

COCs lower the risk of becoming pregnant primarily by suppressing ovulation. Other possible mechanisms may include cervical mucus changes that inhibit sperm penetration and endometrial changes that reduce the likelihood of implantation.

Non-Clinical Toxicology
Do not prescribe Tydemy to women who are known to have the following:

ID1035

Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptives (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs should not be used by women who are over 35 years of age and smoke

Because tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage.

Since bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisable to avoid giving tetracycline-class drugs in conjunction with penicillin.

Absorption of tetracyclines is impaired by antacids containing aluminum, calcium, or magnesium, and iron-containing preparations.

The concurrent use of tetracycline and methoxyflurane has been reported to result in fatal renal toxicity.

Concurrent use of tetracyclines with oral contraceptives may render oral contraceptives less effective.

Administration of isotretinoin should be avoided shortly before, during, and shortly after minocycline therapy. Each drug alone has been associated with pseudotumor cerebri (see ).

Increased risk of ergotism when ergot alkaloids or their derivatives are given with tetracyclines.

Stop Tydemy if an arterial or venous thrombotic (VTE) event occurs.

Based on presently available information on DRSP-containing COCs with 0.03 mg ethinyl estradiol (that is, Yasmin), DRSP-containing COCs may be associated with a higher risk of venous thromboembolism (VTE) than COCs containing the progestin levonorgestrel or some other progestins. Epidemiologic studies that compared the risk of VTE reported that the risk ranged from no increase to a three-fold increase. Before initiating use of Tydemy in a new COC user or a woman who is switching from a contraceptive that does not contain DRSP, consider the risks and benefits of a DRSP-containing COC in light of her risk of a VTE. Known risk factors for VTE include smoking, obesity, and family history of VTE, in addition to other factors that contraindicate use of COCs  

A number of studies have compared the risk of VTE for users of Yasmin (which contains 0.03 mg of EE and 3 mg of DRSP) to the risk for users of other COCs, including COCs containing levonorgestrel. Those that were required or sponsored by regulatory agencies are summarized in Table 1.

In addition to these "regulatory studies," other studies of various designs have been conducted. Overall, there are two prospective cohort studies (see Table 1): the US post-approval safety study Ingenix [Seeger 2007], the European post-approval safety study EURAS (European Active Surveillance Study) [Dinger 2007]. An extension of the EURAS study, the Long-Term Active Surveillance Study (LASS), did not enroll additional subjects, but continued to assess VTE risk. There are three retrospective cohort studies: one study in the US funded by the FDA (see Table 1), and two from Denmark [Lidegaard 2009, Lidegaard 2011]. There are two case-control studies: the Dutch MEGA study analysis [van Hylckama Vlieg 2009] and the German case-control study [Dinger 2010]. There are two nested case-control studies that evaluated the risk of non-fatal idiopathic VTE: the PharMetrics study [Jick 2011] and the GPRD study [Parkin 2011]. The results of all of these studies are presented in Figure 1.

Figure 1: VTE Risk with Yasmin Relative to LNG-Containing COCs (adjusted risk)

Risk ratios displayed on logarithmic scale; risk ratio < 1 indicates a lower risk of VTE for DRSP, > 1 indicates an increased risk of VTE for DRSP.

*

†

#

(References: Ingenix [Seeger 2007], EURAS (European Active Surveillance Study) [Dinger 2007], LASS (Long-Term Active Surveillance Study) [Dinger, unpublished document on file], FDA-funded study [Sidney 2011], Danish [Lidegaard 2009], Danish re-analysis [Lidegaard 2011], MEGA study [van Hylckama Vlieg 2009], German Case-Control study [Dinger 2010], PharMetrics [Jick 2011], GPRD study [Parkin 2011])

Although the absolute VTE rates are increased for users of hormonal contraceptives compared to non-users, the rates during pregnancy are even greater, especially during the post-partum period (see Figure 2). The risk of VTE in women using COCs has been estimated to be 3 to 9 per 10,000 woman-years. The risk of VTE is highest during the first year of use. Data from a large, prospective cohort safety study of various COCs suggest that this increased risk, as compared to that in non-COC users, is greatest during the first 6 months of COC use. Data from this safety study indicate that the greatest risk of VTE is present after initially starting a COC or restarting (following a 4 week or greater pill-free interval) the same or a different COC.

The risk of thromboembolic disease due to oral contraceptives gradually disappears after COC use is discontinued.

Figure 2 shows the risk of developing a VTE for women who are not pregnant and do not use oral contraceptives, for women who use oral contraceptives, for pregnant women, and for women in the postpartum period. To put the risk of developing a VTE into perspective: If 10,000 women who are not pregnant and do not use oral contraceptives are followed for one year, between 1 and 5 of these women will develop a VTE.

Figure 2: Likelihood of Developing a VTE

If feasible, stop Tydemy at least 4 weeks before and through 2 weeks after major surgery or other surgeries known to have an elevated risk of thromboembolism.

Start Tydemy no earlier than 4 weeks after delivery, in women who are not breastfeeding. The risk of postpartum thromboembolism decreases after the third postpartum week, whereas the risk of ovulation increases after the third postpartum week.

Use of COCs also increases the risk of arterial thromboses such as strokes and myocardial infarctions, especially in women with other risk factors for these events.

COCs have been shown to increase both the relative and attributable risks of cerebrovascular events (thrombotic and hemorrhagic strokes), although, in general, the risk is greatest among older (>35 years of age), hypertensive women who also smoke. COCs also increase the risk for stroke in women with other underlying risk factors.

Oral contraceptives must be used with caution in women with cardiovascular disease risk factors.

Stop Tydemy if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions. Evaluate for retinal vein thrombosis immediately

The following serious adverse reactions with the use of COCs are discussed elsewhere in the labeling:

Adverse reactions commonly reported by COC users are:

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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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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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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).