A1, A2, B, C1, C2, D, E, F, G-H, I-K, L, M, N, O, P1, P2, Q-R, S, T, U-V, W-Z

Colazal Indications, Dosage, Storage, Stability - Balsalazide

INDICATIONS

AND USES

COLAZAL is indicated for the treatment of mildly to moderately active ulcerative colitis. Safety and effectiveness of COLAZAL beyond 12 weeks has not been established.

DOSAGE AND ADMINISTRATION

For Treatment of Active Ulcerative Colitis the usual dose in adults is three 750 mg COLAZAL capsules to be taken three times a day for a total daily dose of 6.75 grams for a duration of 8 weeks. Some patients in the clinical trials required treatment for up to 12 weeks.

HOW SUPPLIED

COLAZAL is available as beige capsules containing 750 mg balsalazide and CZ imprinted in black.

NDC 65649-101-02 Bottles of 280 capsules

Store at 25^°C (77^°F); excursions permitted to 15-30^°C (59-86^°F). See USP Controlled Room Temperature.

Rx only
Manufactured for Salix Pharmaceuticals, Inc., Raleigh, N.C. 27607
by: Anabolic, Inc., Irvine, CA 92712
* COLAZAL® is a trademark of Salix Pharmaceuticals, Inc.
Copyright © 2000 Salix Pharmaceuticals, Inc.
6075.02/August 2002

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