BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE
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butalbital,
acetaminophen and
caffeine tablet
Med Health Pharma, LLC
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Butalbital, Acetaminophen and Caffeine is supplied in tablet form for oral administration. Each tablet contains:
Butalbital, USP ……………………………………………………50 mg
Acetaminophen ……………………………………………………500 mg
Caffeine, USP ……………………………………………………..40 mg
In addition, each tablet contains the following inactive ingredients: Colloidal Silicon Dioxide, Corn Starch, Magnesium Stearate, Microcrystalline Cellulose, Sodium Starch Glycolate, and Stearic Acid.
Butalbital (5-allyl-5-isobutylbarbituric acid), a white, odorless, crystalline powder having a slightly bitter taste, is a short to intermediate-acting barbiturate. It has the following structural formula:
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:
Caffeine (1,3,7,-trimethylxanthine), a bitter, white crystalline powder or white-glistening needles, is a central nervous system stimulant. It has the following structural formula:
This combination drug product is intended as a treatment for tension headache.
It consists of a fixed combination of butalbital, acetaminophen and caffeine. The role each component plays in the relief of the complex of symptoms known as tension headache is incompletely understood.
Butalbital is habit-forming and potentially abusable. Consequently, the extended use of this product is not recommended.
General
Butalbital, acetaminophen, and caffeine tablets should be prescribed with caution in certain special-risk patients, such as the elderly or debilitated, and those with severe impairment of renal or hepatic function, or acute abdominal conditions.
BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE
butalbital, acetaminophen, and caffeine tablet |
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Marketing Information | |||
Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
ANDA | ANDA040336 | 01/10/2011 | 03/19/2012 |
Labeler - Med Health Pharma, LLC (962603812) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Med Health Pharma, LLC | 962603812 | repack |
Revised: 01/2011 Med Health Pharma, LLC