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

INDICATIONS AND USAGE

Butalbital and Acetaminophen Tablets 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.

HOW SUPPLIED

Butapap Tablets (Butalbital and Acetaminophen Tablets) 50 mg/650 mg are supplied in bottles of 100 tablets, NDC 46672-098-10, and in bottles of 500 tablets, NDC 46672-098-50. Each tablet contains butalbital 50 mg (Warning: May be habit forming) and acetaminophen 650 mg. Tablets are uncoated, blue, capsule-shaped and are debossed “MIA/l12” on the same side as the single-score.

Storage: Protect from light and moisture. Store at controlled room temperature, 15°C to 30°C (59°F to 86°F).

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

Rx only

Manufactured by:
MIKART, INC.
Atlanta, GA 30318

Rev. 05/00 Code 612Z00