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Asacol

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Asacol

INDICATIONS

Asacol (mesalamine delayed-release tablets) tablets are indicated for the treatment of mildly to moderately active ulcerative colitis and for the maintenance of remission of ulcerative colitis.

DOSAGE AND ADMINISTRATION

For the treatment of mildly to moderately active ulcerative colitis

The usual dosage in adults is two 400-mg tablets to be taken three times a day for a total daily dose of 2.4 grams for a duration of 6 weeks.

For the maintenance of remission of ulcerative colitis

The recommended dosage in adults is 1.6 grams daily, in divided doses. Treatment duration in the prospective, well-controlled trial was 6 months.

Two Asacol (mesalamine delayed-release tablets) 400 mg tablets have not been shown to be bioequivalent to one Asacol® HD (mesalamine) delayed-release 800 mg tablet.

HOW SUPPLIED

Asacol (mesalamine delayed-release tablets) tablets are available as red-brown, capsule-shaped tablets containing 400 mg mesalamine and imprinted “Asacol (mesalamine delayed-release tablets) NE” in black.

NDC 0149-0752-15 Bottle of 180

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

Manufactured by: Warner Chilcott Deutschland GmbH D-64331 Weiterstadt Germany. Marketed by: Warner Chilcott Pharmaceuticals Inc. Mason, OH 45040. 1-800-836-0658. To report SUSPECTED ADVERSE REACTIONS, contact Warner Chilcott at 1-800-836-0658 or FDA at 1-800-FDA-1088 or www.fda.gov/m edwatch. Revised May 2010.

Last reviewed on RxList: 6/17/2010
This monograph has been modified to include the generic and brand name in many instances.

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