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Butalbital and Acetaminophen Capsule
  • Professionals
  • FDA PI

Butalbital and Acetaminophen Capsule

Dosage form: capsule
Drug class:Analgesic combinations

Medically reviewed by Drugs.com. Last updated on Feb 1, 2021.

BOXED WARNING

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.

Butalbital and Acetaminophen Capsule Description

Each capsule for oral administration contains butalbital USP, 50 mg and acetaminophen USP, 300 mg.


In addition, each capsule also contains the following inactive ingredients: crospovidone, FD&C Blue #1, FD&C Red #3, gelatin, microcrystalline cellulose, povidone, pregelatinized starch, sodium lauryl sulphate, stearic acid, talc and titanium dioxide. In addition, capsule printing ink contains ammonium hydroxide, black iron oxide, propylene glycol and shellac glaze.

Butalbital (5-allyl-5