Butalbital Acetaminophen and Caffeine Acetaminophen 325 MG butalbital 50 MG Caffeine 40 MG Oral Tablet

INDICATIONS AND USAGE Butalbital, acetaminophen and caffeine tablets 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.

Qualitest Pharmaceuticals

FDA Reported Adverse Reactions
`[1] malignant neoplasm progression` `[2] nausea` `[3] drug ineffective` `[4] diarrhoea` `[5] off label use` `[6] anaemia` `[7] fatigue` `[8] neutropenia` `[9] death` `[10] disease progression`

6 years ago

ROUND WHITE V 2355

HOW SUPPLIED Butalbital, Acetaminophen and Caffeine Tablets, USP Containing 50 mg butalbital, 325 mg acetaminophen and 40 mg caffeine. Available as white, round shaped tablets, debossed "2355" on one side, and debossed "V" on the reverse side. Bottles of 100: NDC 0603-2544-21 Bottles of 500: NDC 0603-2544-28 Store and Dispense Store at 20° to 25°C (68° to 77°F) with excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]; dispense in a tight, light-resistant container as defined in the USP. Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977 OS2544H-01-1-01 Revised: 10/2019

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