Acetaminophen 300 MG butalbital 50 MG Caffeine 40 MG Oral Capsule
INDICATIONS AND USAGE Butalbital, Acetaminophen and Caffeine Capsules, USP 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.
Actavis Pharma, Inc.
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HOW SUPPLIED
BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE capsules USP, 50 mg/300 mg/40 mg Containing 50 mg butalbital, 300 mg acetaminophen, and 40 mg caffeine. Available as hard gelatin capsules with a light blue opaque body and a light blue opaque cap. Cap is imprinted twice with "FIORICET" in black and body is imprinted twice with a three-head profile " " in black. The capsules are supplied in bottles of 100 capsules (NDC 0591-2640-01) and 500 capsules (NDC 0591-2640-05). Store at 20 o to 25 o C (68 o to 77 o F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container. Rx only Manufactured by: LGM Pharma Solutions, LLC Irvine, CA 92614 Manufactured for: Teva Pharmaceuticals USA, Inc. Parsippany, NJ 07054 7029-0100-WG-EC Rev. 01/2021 Watson 3 Heads Imprint
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