Phrenilin (Butalbital / Acetaminophen) - Indications and Dosage

INDICATIONS AND USAGE

PHRENILIN^® tablets and PHRENILIN^® FORTE 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 habitforming and potentially abusable.

DOSAGE AND ADMINISTRATION

PHRENILIN^®: One or two tablets every four hours. Total daily dosage should not exceed 6 tablets.

PHRENILIN^® FORTE: One capsule every four hours. Total daily dosage should not exceed 6 capsules.

Extended and repeated use of these products is not recommended because of the potential for physical dependence.

HOW SUPPLIED

PHRENILIN^®: Pale violet scored tablets with the letter V on one side and 0842 on the other, in bottles of 100 (NDC 0187-0842-01). Each tablet contains butalbital, USP 50 mg and acetaminophen, USP 325 mg.

PHRENILIN^® FORTE: Amethyst, opaque capsules imprinted with Valeant and PF0844, in bottles of 100 (NDC 0187-0844-01) and 500 (NDC 0187-0844-02). Each capsule contains butalbital, USP 50 mg and acetaminophen, USP 650 mg.

Store PHRENILIN^® and PHRENILIN^® FORTE (Butalbital and Acetaminophen) at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F). Dispense in a tight container as defined in the USP.

Distributed by:
Valeant Pharmaceuticals North America
One Enterprise
Aliso Viejo, CA 92656 USA

Manufactured by:
Mallinckrodt Inc.
Hobart, NY 13788

Insert printed with food grade ink.
MG #21838

Rev. 03/07
Part No. L2PP06