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Asacol HD

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Asacol HD

Asacol HD

INDICATIONS

Asacol HD (mesalamine delayed-release tablets, oral) is indicated for the treatment of moderately active ulcerative colitis. Safety and effectiveness of Asacol HD (mesalamine delayed-release tablets, oral) beyond 6 weeks has not been established.

DOSAGE AND ADMINISTRATION

For the treatment of moderately active ulcerative colitis, the recommended dose of Asacol HD (mesalamine delayed-release tablets, oral) in adults is two 800 mg tablets to be taken three times daily with or without food, for a total daily dose of 4.8 g, for a duration of 6 weeks. Asacol HD (mesalamine delayed-release tablets, oral) use beyond 6 weeks has not been evaluated. Asacol HD (mesalamine delayed-release tablets, oral) should be swallowed whole without cutting, breaking, or chewing. One Asacol HD (mesalamine delayed-release tablets, oral) 800 mg tablet has not been shown to be bioequivalent to two Asacol 400 mg tablets [see CLINICAL PHARMACOLOGY].

HOW SUPPLIED

Dosage Forms And Strengths

Asacol HD (mesalamine delayed-release tablets, oral) delayed-release tablets are available as red-brown, capsule-shaped tablets containing 800 mg mesalamine and imprinted with “PG 800” in black.

Storage And Handling

Asacol HD tablets are available as red-brown, capsule-shaped tablets containing 800 mg mesalamine and imprinted with “PG 800” in black.

NDC 0149-0783-01 Bottle of 180

Store at controlled room temperature 20° to 25°C (68° to 77°F) [See USP].

Procter & Gamble Pharmaceuticals, Inc., Cincinnati, OH 45202, under license from Medeva Pharma Suisse AG. Made in Germany, D-64331 Weiterstadt.

Last reviewed on RxList: 10/23/2009
This monograph has been modified to include the generic and brand name in many instances.

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