February 22, 2017
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Allzital

"Medscape Medical News

Pauline Anderson
August 22, 2015

The US Food and Drug Administration (FDA) has granted tentative approval to expand the label for an extended-release formulation of topiramate (Trokendi XR, Supernus "...

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Allzital

ALLZITAL
(butalbital and acetaminophen) Tablets

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 4,000 milligrams per day, and often involve more than one acetaminophen-containing product.

DRUG DESCRIPTION

Each Butalbital and Acetaminophen 50 mg/ 325 mg tablet for oral administration contains:

Butalbital, USP.................50 mg
Acetaminophen, USP....... 325 mg

Each ALLZITAL (butalbital and acetaminophen 25 mg/ 325 mg) tablet for oral administration contains:

Butalbital, USP.................25 mg
Acetaminophen, USP....... 325 mg

In addition, each ALLZITAL (butalbital and acetaminophen) tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid.

Butalbital (5-allyl-5-isobutylbarbituric acid), a slightly bitter, white, odorless, crystalline powder, is a short to intermediate-acting barbiturate. It has the following structural formula:

Butalbital - Structural formula illustration

C 11H 16N2O 3    M.W. = 224.26

Acetaminophen (4'-hydroxyacetanilide), a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula:

Acetaminophen - Structural formula illustration

C 8H 9NO 2    M.W. = 151.16

Last reviewed on RxList: 12/17/2015
This monograph has been modified to include the generic and brand name in many instances.

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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