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Delzicol

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Delzicol

INDICATIONS

Delzicol™ (mesalamine) delayed-release capsules 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 recommended dose of Delzicol in adults is two 400 mg capsules to be taken three times daily (total daily dose of 2.4 g), for a duration of 6 weeks.

For the maintenance of remission of ulcerative colitis, the recommended dose of Delzicol in adults is 1.6 g daily, in divided doses [see Clinical Studies].

Swallow whole, do not cut, break, or chew.

Delzicol should be dosed at least 1 hour before a meal or 2 hours after a meal.

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

HOW SUPPLIED

Dosage Forms And Strengths

Delzicol (mesalamine) delayed-release capsules are red capsules containing 400 mg mesalamine and imprinted with “WC 400mg” in white.

Storage And Handling

Delzicol (mesalamine) delayed-release capsules are available as red capsules containing 400 mg mesalamine and imprinted with “WC 400mg” in white.

NDC 0430-0753-27 Bottle of 180 capsules

Store at controlled room temperature 20° to 25° C (68° to 77° F); excursions are permitted 15° to 30° C (59° to 86° F). [See USP Controlled Room Temperature]

Manufactured by: Warner Chilcott Deutschland GmbH D-64331 Weiterstadt Germany. Marketed by: Warner Chilcott (US), LLC Rockaway, NJ 07866. Revised: Feb 2013

Last reviewed on RxList: 2/19/2013
This monograph has been modified to include the generic and brand name in many instances.

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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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