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

INDICATIONS

Fioricet® with Codeine (butalbital, acetaminophen, caffeine, and codeine phosphate) is indicated for the relief of the symptom complex of tension (or muscle contraction) headache.

Evidence supporting the efficacy and safety of Fioricet® with Codeine (butalbital, acetaminophen, caffeine, and codeine phosphate) 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

Fioricet® with Codeine
(butalbital, acetaminophen, caffeine, and codeine phosphate) Capsules
Dark blue, opaque cap with a light grey, opaque body. Cap is imprinted twice with “FIORICET’’ and “CODEINE” in light blue. Body is imprinted twice with four-head profile “

Bottles of 100 are supplied with child-resistant closures. (NDC 52544-958-01)

Store and Dispense

Below 30°C (86°F); tight container.

Rx only

Watson Pharmaceuticals, Inc.
Corona, CA 92880 USA

Revised: January 2007

FCETCOD01/07
S0107