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No dosage adjustment is necessary in elderly patients, in patients with renal disease or in patients with mild to moderate hepatic impairment. Administration of rabeprazole to patients with mild to moderate liver impairment resulted in increased exposure and decreased elimination. Due to the lack of clinical data on rabeprazole in patients with severe hepatic impairment, caution should be exercised in those patients. ACIPHEX® tablets should be swallowed whole. The tablets should not be chewed, crushed, or split. ACIPHEX® can be taken with or without food. HOW SUPPLIED Text Continues Below

ACIPHEX® 20 mg is supplied as delayed-release light yellow enteric-coated tablets. The name and strength, in mg, (ACIPHEX 20) is imprinted on one side. Bottles of 30 (NDC# 62856-243-30) Bottles of 90 (NDC# 62856-243-90) Unit Dose Blisters Package of 100 (10 x 10) (NDC# 62856-243-41) Store at 25° C (77° F); excursions permitted to 15-30° C (59-86° F). Protect from moisture. REFERENCES 1. National Committee for Clinical Laboratory Standards. Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically— Fifth Edition. Approved Standard NCCLS Document M7-A5, Vol. 20, No. 2, NCCLS, Wayne, PA, January 2000. Rx only. ACIPHEX® is a registered trademark of Eisai Co., Ltd., Tokyo, Japan. Manufactured and Marketed by Eisai Inc., Teaneck, NJ 07666 Marketed by Janssen Pharmaceutica Inc., Titusville, NJ 08560 Revised August 2003 200298 © 2003 Eisai Inc.
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