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Urso Indications, Dosage, Storage, Stability - Ursodiol
INDICATIONS AND USAGE
URSO 250® and URSO ForteTM (ursodiol) tablets are indicated for the treatment of patients with primary biliary cirrhosis.
The recommended adult dosage for URSO 250® and URSO ForteTM in the treatment of PBC is 13-15 mg/kg/day administered in two to four divided doses with food. Dosing regimen should be adjusted according to each patient’s need at the discretion of the physician.
Each URSO 250® elliptical, biconvex, film-coated tablet, white, engraved with "URS785", contains 250 mg of ursodiol. Available in bottles of 100 tablets (NDC 58914-785-10) and 500 tablets (NDC 58914-785-50).
Each URSO ForteTM elliptical, biconvex, film-coated tablet, white, engraved with "URS790", contains 500 mg of ursodiol. Available in bottles of 100 tablets (NDC 58914-790-10) and 500 tablets (NDC 58914-790-50).
Store at 20oC to 25oC (68oF to 77oF). Dispense in a tight container.
Manufactured in Canada for: AXCAN SCANDIPHARM INC., 22 Inverness Center Parkway, Birmingham, AL 35242, USA, July 2004, Printed in Canada.
AXCAN SCANDIPHARM INC., 22 Inverness Center Parkway Birmingham, Alabama 35242, Tel (800) 472-2634, Fax(205) 991-8426 www.axcan.com.
® Registered trademarks, TM trademarks, and SM servicemarks are used under license by Axcan Scandipharm Inc., Actigall® is a registered trademark of Watson Pharmaceuticals, Inc., ©2004 Axcan Scandipharm
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