Drug Catalog - Product Detail
BUTALBITAL-ACETAMINOPHEN ORAL TABLET 50/325MG 100CT
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 47781-0535-01 | ALVOGEN | 100 | 50-325MG | TABLET |
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Description
DESCRIPTION Butalbital and acetaminophen are supplied in tablet form for oral administration. 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: C 11 H 16 N 2 O 3 MW = 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: C 8 H 9 NO 2 MW = 151.16 Each tablet contains: Butalbital ……………………………… 50 mg Acetaminophen ……………………… 325 mg In addition, each tablet contains the following inactive ingredients: croscarmellose sodium, crospovidone, povidone, pregelatinized starch, colloidal silicon dioxide, microcrystalline cellulose, and stearic acid. butalbital-image acetaminophen-image
How Supplied
HOW SUPPLIED Butalbital and acetaminophen tablets, each tablet of which contains butalbital 50 mg and acetaminophen 325 mg, are supplied in bottles of 100 tablets. Tablets are uncoated, white, capsule-shaped and are debossed “τ/255”. Storage Protect from light and moisture. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container with a child-resistant closure.
Indications & Usage
INDICATIONS AND USAGE Butalbital and acetaminophen 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 Oral: One to two tablets every four hours as needed. Total daily dosage should not exceed six tablets. Extended and repeated use of butalbital and acetaminophen tablets is not recommended because of the potential for physical dependence.