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RE-PB HYOS ELIXIR
Overview
What is RE-PB HYOS ELIXIR?
Each 5 mL (teaspoonful) of elixir contains:
Phenobarbital, USP ............................................. 16.2 mg(WARNING: may be habit forming)Hyoscyamine Sulfate, USP .............................. 0.1037 mgAtropine Sulfate, USP ..................................... 0.0194 mgScopolamine Hydrobromide, USP ................... 0.0065 mgAlcohol not more than 23.8%
INACTIVE INGREDIENTS:
Artificial Grape Flavor, Ethyl Alcohol, FD and C Blue #1, FD and C Red #40, Glycerin, Purified Water USP, Sodium Saccharin,Sorbitol Solution 70%, and Sucrose.
What does RE-PB HYOS ELIXIR look like?
What are the available doses of RE-PB HYOS ELIXIR?
Sorry No records found.
What should I talk to my health care provider before I take RE-PB HYOS ELIXIR?
Sorry No records found
How should I use RE-PB HYOS ELIXIR?
FDA has classified the following indications as “possibly” effective: For use as adjunctive therapy in the treatment ofirritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis. May also be useful asadjunctive therapy in the treatment of duodenal ulcer.IT HAS NOT BEEN SHOWN CONCLUSIVELY WHETHER ANTICHOLINERGIC/ ANTISPASMODIC DRUGS AID IN THEHEALING OF A DUODENAL ULCER, DECREASE THE RATE OF RECURRENCES OR PREVENT COMPLICATIONS.
The dosage of RE-PB Hyos Elixir should be adjusted to the needs of the individual patient to assuresymptomatic control with a minimum of adverse effects.
Adults:
Pediatric patients:
What interacts with RE-PB HYOS ELIXIR?
RE-PB Hyos Elixir is contraindicated in patients with known hypersensitivity to any of the ingredients. Phenobarbital iscontraindicated in patients with acute intermittent porphyria and in those patients in which phenobarbital producesrestlessness and/or excitement.
It is also contraindicated in patients with glaucoma, obstructive uropathy; paralytic ileus; myasthenia gravis;intestinal atony; unstable cardiovascular status in acute hemorrhage; hiatal hernia associated with reflux esophagitis;obstructive disease of the gastrointestinal tract; or severe ulcerative colitis
What are the warnings of RE-PB HYOS ELIXIR?
Keep out of the reach of children.
Heat prostration can occur with belladonna alkaloids in high temperatures.
Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy.In this instance, treatment with this drug could be harmful.
RE-PB Hyos Elixir may produce drowsiness and blurred vision. The patient should be warned about engaging in hazardous work or activities requiring mental alertness, such as operating a motor vehicle or other machinery. Phenobarbital may decrease the effect of anticoagulants, and larger doses of the anticoagulant may be needed for optimal effect. When phenobarbital is discontinued, the dose of the anticoagulant may have to be decreased. Phenobarbital may be habit forming and should not be administered to patients who are susceptible to addiction or to those with a history of physical and/or psychological drug dependence.
Barbiturates should be used with caution in patients with hepatic dysfunction.
What are the precautions of RE-PB HYOS ELIXIR?
GENERAL:Use with caution in patients with: autonomic neuropathy, hepatic or renal disease, hyperthyroidism, coronary heartdisease, congestive heart failure, cardiac arrhythmias, tachycardia, and hypertension.
Belladonna alkaloids may produce a delay in gastric emptying (antral stasis) which would complicate the management ofgastric ulcer. Do not rely on the use of the drug in the presence of complication of biliary tract disease. Theoretically,with overdosage, a curare-like action may occur.
CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY: Long-term studies in animals have not been performed to evaluate carcinogenic potential.
PREGNANCY CATEGORY C:Animal reproduction studies have not been conducted with RE-PB Hyos Elixir. It is not known whether RE-PB Hyos Elixircan cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. RE-PB Hyos Elixirshould be given to a pregnant woman only if clearly needed.
NURSING MOTHERS:It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, cautionshould be exercised when RE-PB Hyos Elixir is administered to a nursing woman.
What are the side effects of RE-PB HYOS ELIXIR?
Adverse reactions associated with anticholinergics and/or anticonvulsants are: dry mouth; tachycardia; urinaryhesitancy and retention; palpitation; blurred vision; prolonged pupil dilation; cycloplegia; increased ocular tension; loss oftaste sense; headache; nervousness; drowsiness; weakness; dizziness; insomnia; nausea; vomiting; severe allergicreaction or drug idiosyncrasies, including anaphylaxis, hives and/or other dermal manifestations; decreased sweating; impotence; suppression of lactation; constipation; bloated feeling and musculoskeletal pain. Elderly patients may reactwith symptoms of excitement, agitation and drowsiness to even small doses of the drug. Phenobarbital may produceexcitement in some patients, rather than a sedative effect. In patients habituated to barbiturates, abrupt withdrawal mayproduce delirium or convulsions.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
What should I look out for while using RE-PB HYOS ELIXIR?
RE-PB Hyos Elixir is contraindicated in patients with known hypersensitivity to any of the ingredients. Phenobarbital iscontraindicated in patients with acute intermittent porphyria and in those patients in which phenobarbital producesrestlessness and/or excitement.
It is also contraindicated in patients with glaucoma, obstructive uropathy; paralytic ileus; myasthenia gravis;intestinal atony; unstable cardiovascular status in acute hemorrhage; hiatal hernia associated with reflux esophagitis;obstructive disease of the gastrointestinal tract; or severe ulcerative colitis
Heat prostration can occur with belladonna alkaloids in high temperatures.
Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy.In this instance, treatment with this drug could be harmful.
RE-PB Hyos Elixir may produce drowsiness and blurred vision. The patient should be warned about engaging in hazardous work or activities requiring mental alertness, such as operating a motor vehicle or other machinery. Phenobarbital may decrease the effect of anticoagulants, and larger doses of the anticoagulant may be needed for optimal effect. When phenobarbital is discontinued, the dose of the anticoagulant may have to be decreased. Phenobarbital may be habit forming and should not be administered to patients who are susceptible to addiction or to those with a history of physical and/or psychological drug dependence.
Barbiturates should be used with caution in patients with hepatic dysfunction.
What might happen if I take too much RE-PB HYOS ELIXIR?
The signs and symptoms of overdose are headache, nausea, vomiting, blurred vision, dilated pupils, hot and
dry skin, dizziness, dryness of the mouth, difficulty in swallowing, and CNS stimulation. Call your doctor or
local Poison Control Center if overdosage is suspected.
How should I store and handle RE-PB HYOS ELIXIR?
Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature]. Protect from light. Keep bottles tightly closed to protect from moisture. It is recommended that the infusion bags be kept in the overwrap until ready to use. Protect infusion bags from freezing.RE-PB Hyos Elixir is a purple colored, grape flavored liquid. NDC 21695-594-16 in bottles of 16 oz. WARNINGS: KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTALOVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.Manufactured by:Great Southern LaboratoriesHouston, TX 77099-3405Manufactured for:River’s Edge Pharmaceuticals, LLCSuwanee, GA 30024Repackaged by: Rebel Distributors CorpThousand Oaks, CA 91320 RE-PB Hyos Elixir is a purple colored, grape flavored liquid. NDC 21695-594-16 in bottles of 16 oz. WARNINGS: KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTALOVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.Manufactured by:Great Southern LaboratoriesHouston, TX 77099-3405Manufactured for:River’s Edge Pharmaceuticals, LLCSuwanee, GA 30024Repackaged by: Rebel Distributors CorpThousand Oaks, CA 91320 RE-PB Hyos Elixir is a purple colored, grape flavored liquid. NDC 21695-594-16 in bottles of 16 oz. WARNINGS: KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTALOVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.Manufactured by:Great Southern LaboratoriesHouston, TX 77099-3405Manufactured for:River’s Edge Pharmaceuticals, LLCSuwanee, GA 30024Repackaged by: Rebel Distributors CorpThousand Oaks, CA 91320 RE-PB Hyos Elixir is a purple colored, grape flavored liquid. NDC 21695-594-16 in bottles of 16 oz. WARNINGS: KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTALOVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.Manufactured by:Great Southern LaboratoriesHouston, TX 77099-3405Manufactured for:River’s Edge Pharmaceuticals, LLCSuwanee, GA 30024Repackaged by: Rebel Distributors CorpThousand Oaks, CA 91320 RE-PB Hyos Elixir is a purple colored, grape flavored liquid. NDC 21695-594-16 in bottles of 16 oz. WARNINGS: KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTALOVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.Manufactured by:Great Southern LaboratoriesHouston, TX 77099-3405Manufactured for:River’s Edge Pharmaceuticals, LLCSuwanee, GA 30024Repackaged by: Rebel Distributors CorpThousand Oaks, CA 91320 RE-PB Hyos Elixir is a purple colored, grape flavored liquid. NDC 21695-594-16 in bottles of 16 oz. WARNINGS: KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTALOVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.Manufactured by:Great Southern LaboratoriesHouston, TX 77099-3405Manufactured for:River’s Edge Pharmaceuticals, LLCSuwanee, GA 30024Repackaged by: Rebel Distributors CorpThousand Oaks, CA 91320 RE-PB Hyos Elixir is a purple colored, grape flavored liquid. NDC 21695-594-16 in bottles of 16 oz. WARNINGS: KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTALOVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.Manufactured by:Great Southern LaboratoriesHouston, TX 77099-3405Manufactured for:River’s Edge Pharmaceuticals, LLCSuwanee, GA 30024Repackaged by: Rebel Distributors CorpThousand Oaks, CA 91320 RE-PB Hyos Elixir is a purple colored, grape flavored liquid. NDC 21695-594-16 in bottles of 16 oz. WARNINGS: KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTALOVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.Manufactured by:Great Southern LaboratoriesHouston, TX 77099-3405Manufactured for:River’s Edge Pharmaceuticals, LLCSuwanee, GA 30024Repackaged by: Rebel Distributors CorpThousand Oaks, CA 91320
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Non-Clinical Toxicology
RE-PB Hyos Elixir is contraindicated in patients with known hypersensitivity to any of the ingredients. Phenobarbital iscontraindicated in patients with acute intermittent porphyria and in those patients in which phenobarbital producesrestlessness and/or excitement.It is also contraindicated in patients with glaucoma, obstructive uropathy; paralytic ileus; myasthenia gravis;intestinal atony; unstable cardiovascular status in acute hemorrhage; hiatal hernia associated with reflux esophagitis;obstructive disease of the gastrointestinal tract; or severe ulcerative colitis
Heat prostration can occur with belladonna alkaloids in high temperatures.
Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy.In this instance, treatment with this drug could be harmful.
RE-PB Hyos Elixir may produce drowsiness and blurred vision. The patient should be warned about engaging in hazardous work or activities requiring mental alertness, such as operating a motor vehicle or other machinery. Phenobarbital may decrease the effect of anticoagulants, and larger doses of the anticoagulant may be needed for optimal effect. When phenobarbital is discontinued, the dose of the anticoagulant may have to be decreased. Phenobarbital may be habit forming and should not be administered to patients who are susceptible to addiction or to those with a history of physical and/or psychological drug dependence.
Barbiturates should be used with caution in patients with hepatic dysfunction.
GENERAL:Use with caution in patients with: autonomic neuropathy, hepatic or renal disease, hyperthyroidism, coronary heartdisease, congestive heart failure, cardiac arrhythmias, tachycardia, and hypertension.
Belladonna alkaloids may produce a delay in gastric emptying (antral stasis) which would complicate the management ofgastric ulcer. Do not rely on the use of the drug in the presence of complication of biliary tract disease. Theoretically,with overdosage, a curare-like action may occur.
CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY: Long-term studies in animals have not been performed to evaluate carcinogenic potential.
PREGNANCY CATEGORY C:Animal reproduction studies have not been conducted with RE-PB Hyos Elixir. It is not known whether RE-PB Hyos Elixircan cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. RE-PB Hyos Elixirshould be given to a pregnant woman only if clearly needed.
NURSING MOTHERS:It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, cautionshould be exercised when RE-PB Hyos Elixir is administered to a nursing woman.
Adverse reactions associated with anticholinergics and/or anticonvulsants are: dry mouth; tachycardia; urinaryhesitancy and retention; palpitation; blurred vision; prolonged pupil dilation; cycloplegia; increased ocular tension; loss oftaste sense; headache; nervousness; drowsiness; weakness; dizziness; insomnia; nausea; vomiting; severe allergicreaction or drug idiosyncrasies, including anaphylaxis, hives and/or other dermal manifestations; decreased sweating; impotence; suppression of lactation; constipation; bloated feeling and musculoskeletal pain. Elderly patients may reactwith symptoms of excitement, agitation and drowsiness to even small doses of the drug. Phenobarbital may produceexcitement in some patients, rather than a sedative effect. In patients habituated to barbiturates, abrupt withdrawal mayproduce delirium or convulsions.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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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