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

INDICATIONS AND USAGE

Butalbital, aspirin, and caffeine capsules are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of butalbital, aspirin, and caffeine capsules 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

Butalbital, aspirin, and caffeine capsules are dark green and light green in color, imprinted with logo "LANNETT" on the cap and "1552" on the body. Each capsule contains: butalbital USP, 50 mg; aspirin USP, 325 mg; caffeine USP, 40 mg and is available as follows:

Bottles of 100   NDC 0527-1552-01

Dispense in a tight, light-resistant container as defined in the USP. Use child-resistant closure. Store below 25°C (77°F).

Protect from moisture.

MANUFACTURED BY
LANNETT COMPANY INC.
PHILADELPHIA, PA 19136

0527
1552
Revised 7/2007