Fiorinal (Butalbital / Caffeine / Aspirin) - Indications and Dosage

INDICATIONS

Fiorinal^® (Butalbital, Aspirin, and Caffeine Capsules, USP) is indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of Fiorinal^® (Butalbital, Aspirin, and Caffeine Capsules, USP) in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.

DOSAGE AND ADMINISTRATION

One or 2 capsules every 4 hours. Total daily dose should not exceed 6 capsules. Extended and repeated use of this product is not recommended because of the potential for physical dependence.

HOW SUPPLIED

Fiorinal ^® (Butalbital, Aspirin, and Caffeine Capsules, USP)

Bright kelly green cap with a bright lime green body. Each half of capsule is imprinted with “FIORINAL 955’’ in red.

Bottles of 100 are supplied with child-resistant closures. (NDC 52544-955-01)

Store and Dispense

Below 25°C (77°F); tight container. Protect from moisture.

Rx only

Watson Pharmaceuticals, Inc.
Corona, CA 92880 USA

FIORINAL01/07
S0107