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Zebutal (Butalbital / Acetaminophen / Caffeine) - Indications and Dosage

 
 



INDICATIONS AND USAGE

ZEBUTAL® 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.

DOSAGE AND ADMINISTRATION

Oral: one capsule every four 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

ZEBUTAL® Capsules brand of butalbital 50 mg (Warning: May be habit-forming), acetaminophen 500 mg and caffeine 40 mg are supplied as salmon/red capsules printed "170" in white ink and are available in:

NDC 59630-170-11     Bottles of 100 capsules.

Store at 20-25oC (68-77oF) [See USP Controlled Room Temperature]. Protect from light and moisture.

PHARMACIST: Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Manufactured For:
Shionogi Inc.
Florham Park, NJ 07932

Manufactured By:
West-ward Pharmaceutical Corp.
Eatontown, NJ 07724

Revised September 2011

ZEB-PI-1

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