Zebutal (Butalbital / Acetaminophen / Caffeine) - Indications and Dosage

INDICATIONS AND USAGE

ZEBUTAL™ Capsules are indicated for the relief of the symptom complex of tension (or muscle contraction) headache.

Evidence supporting the efficacy and safety of this combination product 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

Oral: one capsule every four hours. Total daily dosage should not exceed 6 capsules.

Extended and repeated use of this product is not recommended because of the potential for physical dependence.

HOW SUPPLIED

ZEBUTAL™ Capsules brand of butalbital 50 mg, acetaminophen 500 mg and caffeine 40 mg are supplied as salmon/red capsules printed "

•  NDC 59630-170-10       Bottles of 100 capsules.
•  NDC 59630-170-50       Bottles of 500 capsules.

Store at 20-25°C (68-77°F); excursions permitted to 15-30°C(59-86°F) [See USP Controlled Room Temperature]. Protect from light and moisture.

Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Distributed by:
FIRST
HORIZON
PHARMACEUTICAL ^®
CORPORATION

Alpharetta, GA 30005

Rev January 2004
ZEB-PI-1