RE-PB Hyos Elixir
Generic name:phenobarbital-hyoscyamine sulfate-atropine sulfate-scopolamine hydrobromide
Dosage form: oral elixir
Drug class:Anticholinergics / antispasmodics
Medically reviewed by Drugs.com. Last updated on Nov 22, 2021.
Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
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DESCRIPTION:
Each 5 mL (teaspoonful) of elixir contains:
Phenobarbital, USP ..... 16.2 mg
Hyoscyamine Sulfate, USP ..... 0.1037 mg
Atropine Sulfate, USP ..... 0.0194 mg
Scopolamine Hydrobromide, USP ..... 0.0065 mg
Alcohol not more than 23.8%
INACTIVE INGREDIENTS:
Artificial Grape Flavor, Ethyl Alcohol, FD & C Blue #1, FD & C Red #40, Glycerin, Purified Water USP, Sodium Saccharin, Sorbitol Solution 70%, and Sucrose.
CLINICAL PHARMACOLOGY:
This drug combination provides peripheral anticholinergic/antispasmodic action and mild sedation.
INDICATIONS AND USAGE:
FDA has classified the following indications as “possibly” effective: For use as adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis. May also be useful as adjunctive therapy in the treatment of duodenal ulcer.
IT HAS NOT BEEN SHOWN CONCLUSIVELY WHETHER ANTICHOLINERGIC/ ANTISPASMODIC DRUGS AID IN THE HEALING OF A DUODENAL ULCER, DECREASE THE RATE OF RECURRENCES OR PREVENT COMPLICATIONS.
CONTRAINDICATIONS:
RE-PB Hyos Elixir is contraindicated in patients with known hypersensitivity to any of the ingredients. Phenobarbital is contraindicated in patients with acute intermittent porphyria and in those patients in which phenobarbital produces restlessness 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 colitisWARNINGS:
Heat prostration can occur with belladonna alkaloids in high temperatures.
Diarrhea may be an early symptom of incomplete intestinal o
