Sedapap (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.

DOSAGE AND ADMINISTRATION

Oral: One table every four hours as needed. Total daily dosage should not exceed 6 tablets.

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

HOW SUPPLIED

SEDAPAP® TABLETS (Butalbital and Acetaminophen Tablets) 50 mg/650 mg are supplied in bottles of 100 tablets, NDC 0259-0392-01. Each tablet contains butalbital 50 mg (Warning: May be habit forming) and acetaminophen 650 mg. Tablets are uncoated, white, capsule-shaped and are debossed "MP" score "392" on one side.

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

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

CAUTION: Federal law prohibits dispensing without prescription.

MFG. FOR:

MERZ PHARMACEUTICALS

Greensboro, NC 27407

Rev. 07/01                                                                                                                         Code 805A00