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Donnatal Tablets
  • Professionals
  • FDA PI

Donnatal Tablets

Generic name: phenobarbital, hyoscyamine sulfate, atropine sulfate, scopolamine hydrobromide
Dosage form: tablet
Drug class:Anticholinergics / antispasmodics

Medically reviewed by Drugs.com. Last updated on Aug 1, 2021.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. Read further information about unapproved drugs.

Donnatal Tablets Description

Donnatal® Tablets

Each Donnatal® Tablet contains:

Phenobarbital, USP..... 16.2 mg
Hyoscyamine Sulfate, USP..... 0.1037 mg
Atropine Sulfate, USP .....0.0194 mg
Scopolamine Hydrobromide, USP .....0.0065 mg

Inactive Ingredients

Dibasic Calcium Phosphate Dihydrate, Compressible Sugar, Microcrystalline Cellulose, Sodium Starch Glycolate, Stearic Acid, Silicon Dioxide Colloidal, Magnesium Stearate.

Donnatal Tablets - Clinical Pharmacology

This drug combination provides natural belladonna alkaloids in a specific, fixed ratio combined with phenobarbital to provide peripheral anticholinergic/antispasmodic action and mild sedation.

INDICATIONS AND USAGE
Based on a review of this drug by the National Academy of Sciences-National Research Council and/or other information, FDA has classified the indications as follows: "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.

Final classification of the less-than-effective indications requires further investigation.

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