Drug Catalog - Product Detail
BUTALBITAL/ACETAMINOPHEN 50/300MG TB 100CT
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 68682-0306-01 | OCEANSIDE PHARMACEUTICALS | 100 | 50-300MG | TABLET |
PACKAGE FILES
Generic Name
BUTALBITAL AND ACETAMINOPHEN TABLETS
Substance Name
ACETAMINOPHEN
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA090956
Description
DESCRIPTION Each Butalbital and Acetaminophen Tablet for oral administration, contains Butalbital, USP 50 mg and Acetaminophen, USP 300 mg. In addition, each Butalbital and Acetaminophen Tablet contains the following inactive ingredients: Pregelatinized Starch, Microcrystalline Cellulose, Croscarmellose Sodium, Magnesium Stearate, D&C Yellow #10 Lake, and FD&C Red #40 Lake. 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: 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 M.W.= 151.16 butalbital-structure.jpg APAP Molecule
How Supplied
HOW SUPPLIED Yellowish round, unscored tablets with BA 300 on one side and plain on the other, in bottles of 100 (NDC 68682-306-01). Each tablet contains butalbital, USP 50 mg and acetaminophen, USP 300 mg. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP. KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. Distributed by: Oceanside Pharmaceuticals, a division of Bausch Health US, LLC Bridgewater, NJ 08807 USA © 2020 Bausch Health Companies Inc. or its affiliates 7075-AG 9592801 Rev. 04/2020
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 Butalbital and Acetaminophen Tablets: One or two tablets every four hours. Total daily dosage should not exceed 6 tablets. Extended and repeated use of these products is not recommended because of the potential for physical dependence.