Acetaminophen 300 MG butalbital 50 MG Caffeine 40 MG Oral Capsule

INDICATIONS AND USAGE Butalbital, Acetaminophen and Caffeine 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.

lannett company, inc.

FDA Reported Adverse Reactions
`[1] drug ineffective` `[2] fatigue` `[3] nausea` `[4] pain` `[5] headache` `[6] off label use` `[7] dyspnoea` `[8] diarrhoea` `[9] arthralgia` `[10] toxicity to various agents`

3 years ago

CAPSULE BLUE Lannett 4095

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 size 0 capsule with opaque blue cap imprinted in white with “ Lannett ” and opaque aqua blue body imprinted with “4095” in white and filled with powder. The capsules are supplied in bottles of 100 capsules (NDC 0527-4095-37). Store at 20° to 25° C (68° to 77°F) [see USP Controlled Room Temperature]; Dispense in a tight, light-resistant container. Rx only Distributed by: Lannett Company, Inc. Philadelphia, PA 19136 CIB71940C Rev. 07/23

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Acetaminophen 300 MG butalbital 50 MG Caffeine 40 MG Oral Capsule

FDA Reported Adverse Reactions [1] drug ineffective [2] fatigue [3] nausea [4] pain [5] headache [6] off label use [7] dyspnoea [8] diarrhoea [9] arthralgia [10] toxicity to various agents

CAPSULE BLUE Lannett 4095

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FDA Reported Adverse Reactions
`[1] drug ineffective` `[2] fatigue` `[3] nausea` `[4] pain` `[5] headache` `[6] off label use` `[7] dyspnoea` `[8] diarrhoea` `[9] arthralgia` `[10] toxicity to various agents`