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Drug Catalog - Product Detail

BUTALBITAL/ACETAMINOPHEN & CAFFEINE TABS. TB 50/325/40MG 500

NDC Mfr Size Str Form
00527-1695-05 LANNETT 500 50-325-40MG TABLET
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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: microcrystalline cellulose, crospovidone, croscarmellose sodium, corn starch, stearic acid, colloidal silicon dioxide, magnesium stearate, and FD&C Blue No. 1. Butalbital (5-allyl-5-isobutylbarbituric acid), is a short to intermediate-acting barbiturate. It has the following structural formula: Acetaminophen (4´-hydroxyacetanilide), is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula: Caffeine (1,3,7-trimethylxanthine), is a central nervous system stimulant. It has the following structural formula: butalbitol-molec-struc acetaminophen-molec-struc caffeine-molec-struc
How Supplied
HOW SUPPLIED Butalbital, Acetaminophen, and Caffeine Tablets, USP contain 50 mg butalbital, 325 mg acetaminophen, and 40 mg caffeine. Butalbital, Acetaminophen, and Caffeine Tablets USP, 50 mg/325mg/40 mg are light-blue, speckled, round uncoated tablets, debossed "1695" on one side and "LCI" on the other side and are supplied in bottles of 100 (NDC 0527-1695-01) and bottles of 500 (NDC 0527-1695-05). 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, with a child-resistant closure (as required). Manufactured by: LANNETT COMPANY, INC. Philadelphia, PA 19136 Made in the USA Revised 09/12, Revision 4 10-224
Indications & Usage
INDICATIONS AND USAGE Butalbital, acetaminophen, and caffeine tablets, USP 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 2 tablets every 4 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.