Urso 250 (Ursodiol) - Indications and Dosage

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INDICATIONS AND USAGE

URSO 250™ (ursodiol) tablets are indicated for the treatment of patients with primary biliary cirrhosis.

DOSAGE AND ADMINISTRATION

The recommended adult dosage for URSO 250™ in the treatment of PBC is 13-15 mg/kg/day administered in four divided doses with food.

HOW SUPPLIED

Each URSO 250™ film-coated tablet, white, engraved with "URS785", contains 250 mg of ursodiol. Available in bottles of 500 tablets (NDC 58914-785-50) and 100 tablets (NDC 58914-785-10). Store at 20°C to 25°C (68°F to 77°F). Dispense in a tight container.

Manufactured in Canada for:

Axcan Scandipharm Inc.

22 Inverness Center Parkway

Birmingham, AL 35242

USA

URSO 250™ is a trademark of

Axcan Pharma US Inc.

July 2002

Page last updated: 2006-08-16

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