Atropine Sulfate 0.0194 MG Hyoscyamine Sulfate 0.1037 MG Phenobarbital 16.2 MG Scopolamine Hydrobromide 0.0065 MG Oral Tablet Donnatal
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 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.
pbm pharmaceuticals inc.
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How Supplied Donnatal® Tablets are supplied as: white, D-shaped tablets debossed “D” on one side and “Donnatal” on the other side. Bottles of 100 tablets. Bottles of 1000 tablets. AVOID FREEZING Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Use safety closures when dispensing this product unless otherwise directed by a physician or requested by purchaser. Also available: Donnatal Extentabs® Tablets, the only extended release formulation, in bottles of 100 and 500 tablets. Donnatal® Elixir, a purple colored, grape flavored liquid, in 4 fl oz (118 mL) and 1 pint (473 mL) bottles.
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