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

INDICATIONS AND USAGE

Butalbital, Acetaminophen and Caffeine Tablets, USP 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

One tablet every four hours. Total daily dosage should not exceed 5 tablets.

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

HOW SUPPLIED

Butalbital, Acetaminophen and Caffeine Tablets USP, containing butalbital 50 mg (Warning: May be habit-forming), acetaminophen 750 mg and caffeine 40 mg are pink, oval shaped tablets with a convex face and are debossed “ANDRX” on one side and “075” on the other side.

They are supplied in bottles of 100, NDC 46672-184-10.

STORAGE

Store at controlled room temperature, 15°C to 30°C (59°F to 86°F) [see USP].

Dispense in a tight, light‑resistant container with a child‑resistant closure.

*Trademark of Medical Economics Company, Inc.

Rx Only

Manufactured by:

MIKART, INC.

Atlanta, GA 30318

Distributed by:

ANDRX PHARMACEUTICALS, INC.

Madison, MS 39110

Rev. 01/03Code 886A00