Esgic-Plus (Butalbital / Acetaminophen / Caffeine) - Indications and Dosage

INDICATIONS AND USAGE

Butalbital, Acetaminophen and Caffeine 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.

HOW SUPPLIED

Esgic-Plus^TM (Butalbital, Acetaminophen and Caffeine Capsules USP 50 mg/500 mg/40 mg) are supplied in containers of 100 capsules, NDC 0456-0679-01. Each capsule contains butalbital 50 mg (WARNING: May be habit-forming), acetaminophen 500 mg caffeine 40 mg. Capsules are red and are imprinted “Forest 0372” on the cap and “Esgic Plus^TM ” on the body in white.

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.

Rx only

Manufactured by:

MIKART, INC.

Atlanta, GA 30318

Distributed by:

FOREST PHARMACEUTICALS, INC.

Subsidiary of Forest Labroatories, Inc.

St. Louis, MO 63045

Code 822A00 Rev. 08/02