Drug Catalog - Product Detail
BUTALBITAL/ACETAMINOPHEN & CAFFEINE TABS. 50/325/40MG TB 500
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 69367-0203-05 | WESTMINSTER PHARMACEUTICALS | 500 | 50-325-40MG | TABLET |
PACKAGE FILES
Generic Name
BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE
Substance Name
ACETAMINOPHEN
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA209587
Description
DESCRIPTION Butalbital, Acetaminophen and Caffeine Tablets, USP are supplied in tablet form for oral administration. Each tablet contains the following active ingredients: butalbital, USP 50 mg acetaminophen, USP 325 mg caffeine, USP 40 mg Inactive Ingredients: silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid. Butalbital (5-allyl-5-isobutylbarbituric acid), is a short to intermediate-acting barbiturate. It has the following structural formula: C 11 H 16 N 2 O 3 M.W. 224.26 Acetaminophen (4'-hydroxyacetanilide), is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula: C 8 H 9 NO 2 M.W. 151.16 Caffeine (1,3,7-trimethylxanthine), is a central nervous system stimulant. It has the following structural formula: C 8 H 10 N 4 O 2 M.W. 194.19 Chemical Structure Chemical Structure Chemical Structure
How Supplied
HOW SUPPLIED Butalbital, Acetaminophen, and Caffeine Tablets USP, 50 mg/325 mg/40 mg Tablet containing 50 mg butalbital, 325 mg acetaminophen, and 40 mg caffeine. Available as white to off-white round tablets, debossed "BAC" on one side and debossed "123" on the other side. Bottles of 100 tablets (NDC 69367-203-01) Bottles of 500 tablets (NDC 69367-203-05) Store at 20°-25°C (68°-77°F) with excursions permitted between 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]; dispense in a tight, light resistant container as directed in the USP.
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.
Dosage and Administration
DOSAGE AND ADMINISTRATION One or two tablets every four hours as needed. Total daily dosage should not exceed 6 tablets. Extended and repeated use of this product is not recommended because of the potential for physical dependence.