Donnatal Extentabs

Donnatal Extentabs

INDICATIONS

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.

DOSAGE AND ADMINISTRATION

The dosage of Donnatal Extentabs® (belladonna alkaloids, phenobarbital) should be adjusted to the needs of the individual patient to assure symptomatic control with a minimum of adverse reactions. The usual dose is one tablet every twelve (12) hours. If indicated, one tablet every eight (8) hours may be given.

HOW SUPPLIED

Donnatal Extentabs® (belladonna alkaloids, phenobarbital) Tablets are supplied as: film coated green, round, compressed tablets printed "P421" in black ink.

  • Bottles of 100 tablets
  • Bottles of 500 tablets

Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Protect from light and moisture.

Dispense in a well-closed, light-resistant container as defined in the USP using a child-resistant closure.

Also available: Donnatal® Tablets in bottles of 100 and 1000 tablets and Donnatal® Elixir in 4 fl oz bottles and 1 pint bottles.

PBM Pharmaceuticals, Inc. Gordonsville, VA 22942. FDA Rev date: n/a

Last reviewed on RxList: 4/23/2008
This monograph has been modified to include the generic and brand name in many instances.

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