ZEBUTAL™ CAPSULES BRAND OF
BUTALBITAL, ACETAMINOPHEN, AND
CAFFEINE CAPSULES, USP

Rx Only
Rev. 01/04

ZEBUTAL™ Capsules brand of Butalbital, Acetaminophen, and Caffeine is supplied in capsule form for oral administration. Each ZEBUTAL™ Capsule contains:

•  Butalbital, USP...........................................50 mg
•  Acetaminophen, USP...............................500 mg
•  Caffeine, USP.............................................40 mg

In addition, each capsule contains the following inactive ingredients: Colloidal Silicon Dioxide, Magnesium Stearate, Sodium Lauryl Sulfate, and Sodium Starch Glycolate.

Capsule shell contains: D&C Red #33, D&C Yellow #10, FD&C Red #40, Gelatin and Titanium Dioxide. The imprinting ink contains Titanium Dioxide.

Butalbital (5-allyl-5-isobutylbarbituric acid), a white, odorless, crystalline powder having a slightly bitter taste, is a short to intermediate-acting barbiturate. It has the following structural formula:

Acetaminophen (4'-hydroxyacetanilide), a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula:

Caffeine (1,3,7,-trimethylxanthine), a bitter, white crystalline powder or white-gulening needles, is a central nervous system stimulant. It has the following structural formula:

This combination drug product is intended as a treatment for tension headache.

It consists of a fixed combination of butalbital, acetaminophen, and caffeine. The role each component plays in the relief of the complex of symptoms known as tension headache is incompletely understood.

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.

This product is contraindicated under the following conditions:

• Hypersensitivity or intolerance to any component of this product.
• Patients with porphyria.

Butalbital is habit-forming and potentially abusable. Consequently, the extended use of this product is not recommended.

Following an acute overdosage of butalbital, acetaminophen and caffeine, toxicity may result from the barbiturate or the acetaminophen. Toxicity due to caffeine is less likely, due to the relatively small amounts in this formulation.

Signs and Symptoms: Toxicity from barbiturate poisoning include drowsiness, confusion, and coma; respiratory depression; hypotension; and hypovolemic shock.

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.

ZEBUTAL™ Capsules brand of butalbital 50 mg, acetaminophen 500 mg and caffeine 40 mg are supplied as salmon/red capsules printed " HPC 170" in white ink and are available in:

•  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