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 habitforming and potentially abusable.

DOSAGE AND ADMINISTRATION

Butalbital and Acetaminophen Tablets 50 mg/300 mg: One or two tablets every four hours. Total daily dosage should not exceed 6 tablets.

Extended and repeated use of these products is not recommended because of the potential for physical dependence.

HOW SUPPLIED

Yellowish round, unscored tablets with BA 300 on one side and plain on the other, in bottles of 100 (NDC 0722-7075-01). Each tablet contains butalbital, USP 50 mg and acetaminophen, USP 300 mg.

Store at 20 to 25°C (68 to 77°F) [see USP Controlled Room Temperature].

Dispense in a tight container as defined in the USP.

Manufactured by
Nexgen Pharma, Inc.
Irvine, CA 92614

Rev. 08/2013