NDC 64380-0157-02

Butalbital, Acetaminophen, and Caffeine 325 mg/1, 50 mg/1, 40 mg/1 TABLET

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NDC

64380-0157-02

Generic Name

Butalbital, Acetaminophen, and Caffeine

Brand Name

Butalbital, Acetaminophen and Caffeine

Strength

325 mg/1, 50 mg/1, 40 mg/1

Dosage Form

TABLET

Route

ORAL

Package Size

—

Labeler

Strides Pharma Science Limited

FDA Drug Information

Indications & Usage

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.

Important Warnings

WARNINGS Hepatotoxicity Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 milligrams per day, and often involve more than one acetaminophen-containing product. The excessive intake of acetaminophen may be intentional to cause…

Source: FDA. For professional use only. Not a substitute for prescribing information.

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Other Butalbital, Acetaminophen, and Caffeine NDC Codes

64380-0157-01325 mg/1, 50 mg/1, 40 mg/1TABLET

2-Day

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