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

INDICATIONS AND USAGE

Butalbital, acetaminophen, caffeine, and codeine phosphate capsule is indicated for the relief of the symptom complex of tension (or muscle contraction) headache.

Evidence supporting the efficacy and safety of butalbital, acetaminophen, caffeine, and codeine phosphate capsule in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because codeine and butalbital are habit-forming and potentially abusable.

DOSAGE AND ADMINISTRATION

One or 2 capsules every 4 hours. Total daily dosage should not exceed 6 capsules.

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

HOW SUPPLIED

Butalbital, acetaminophen, caffeine, and codeine phosphate capsules

Light blue opaque cap with a grey, opaque body. Cap is imprinted in black with "V". Body is imprinted with "3109" in black.

Bottles of 10, 100, and 1000.

Store and Dispense

At 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]; in a tight, light-resistant container as defined in the USP.

*Levophed is a registered Trademark of Sanofi Winthrop Pharmaceuticals.