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

 
 



INDICATIONS

Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate capsules are 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 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 combination product is not recommended because of the potential for physical dependence.

HOW SUPPLIED

Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules 50 mg/325 mg/ 40 mg/30 mg are blue, opaque cap with a gray, opaque body, and body is imprinted with “B073” in white ink.

Bottles of 100 (NDC 0722-6670-01)

Bottles of 500 (NDC 0722-6670-05)

Store and Dispense

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

Manufactured by:

Nexgen Pharma, Inc.

Irvine, CA 92614

(Rev. 2/14)

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