Drug Catalog - Product Detail
BUTALBITAL-ASPIRIN-CAFFEINE CAPS 50-325-40MG 100CT
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 00527-1552-01 | LANNETT | 100 | 50-325-40MG | CAPSULE |
PACKAGE FILES
Generic Name
BUTALBITAL, ASPIRIN, AND CAFFEINE
Substance Name
ASPIRIN
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA086996
Description
DESCRIPTION Butalbital, aspirin, and caffeine capsules are supplied in capsule form for oral administration. Each capsule contains the following active ingredients: butalbital, USP.......................... 50 mg aspirin, USP.............................. 325 mg caffeine, USP............................ 40 mg Butalbital (5-allyl-5-isobutylbarbituric acid) is a short- to intermediate-acting barbiturate. It has the following structural formula: Aspirin (benzoic acid, 2-(acetyloxy)-) is an analgesic, antipyretic, and anti-inflammatory. It has the following structural formula: Caffeine (1, 3, 7-trimethylxanthine) is a central nervous system stimulant. It has the following structural formula: Inactive Ingredients: pregelatinized starch, microcrystalline cellulose, sodium starch glycolate, trimyristin, talc, colloidal silicon dioxide, D&C Yellow No. 10, FD&C Green No. 3, and gelatin. The capsule imprinting ink contains: shellac glaze in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, ethanol, methanol, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, and D&C Yellow No.10 Aluminum Lake. butalbital-molec-structure aspirin-molec-structure caffeine-molec-structure
How Supplied
HOW SUPPLIED Butalbital, aspirin, and caffeine capsules are dark green and light green in color, imprinted with logo "LANNETT" on the cap and "1552" on the body. Each capsule contains: butalbital USP, 50 mg; aspirin USP, 325 mg; caffeine USP, 40 mg and is available as follows: Bottles of 100 NDC 0527-1552-01 Dispense in a tight container as defined in the USP. Use child-resistant closure. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from moisture. For all medical inquiries contact: Lannett Company, Inc. 1-844-834-0530 Distributed by: Lannett Company, Inc. Philadelphia, PA 19136 All trademarks are the property of their respective owners. CIB70308E Rev. 05/21
Indications & Usage
INDICATIONS AND USAGE Butalbital, aspirin, and caffeine capsules are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of butalbital, aspirin, and caffeine capsules 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 capsules every 4 hours. Total daily dose should not exceed 6 capsules. Extended and repeated use of this product is not recommended because of the potential for physical dependence.