Asacol (Mesalamine) - Indications and Dosage

INDICATIONS AND USAGE

Asacol 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.

HOW SUPPLIED

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

NDC 0149-0752-15 Bottle of 180

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

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

U.S. Patent Nos. 5,541,170 and 5,541,171

REVISED October 2007