FDA Label for Butalbital, Acetaminophen And Caffeine
View Indications, Usage & Precautions
Butalbital, Acetaminophen And Caffeine Product Label
The following document was submitted to the FDA by the labeler of this product Keltman Pharmaceuticals Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Description
Butalbital, Acetaminophen and Caffeine is supplied in tablet form for oral administration. Each tablet contains:
Butalbital, USP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50 mg
Acetaminophen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .500 mg
Caffeine, USP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40 mg
In addition, each tablet contains the following inactive ingredients: Colloidal Silicon Dioxide, Corn Starch, Croscarmellose Sodium, Magnesium Stearate, Microcrystalline Cellulose, Pregelatinized Starch, Povidone, Sodium Starch Glycolate, and Stearic Acid.
Butalbital (5-allyl-5-isobutylbarbituric acid), a white, odorless, crystalline powder having a slightly bitter taste, 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:
Caffeine (1,3,7,-trimethylxanthine), a bitter, white crystalline powder or white-glistening needles, is a central nervous system stimulant. It has the following structural formula:
Clinical Pharmacology
This combination drug product is intended as a treatment for tension headache.
It consists of a fixed combination of butalbital, acetaminophen and caffeine. The role each component plays in the relief of the complex of symptoms known as tension headache is incompletely understood.
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.
Contraindications
This product is contraindicated under the following conditions:
- Hypersensitivity or intolerance to any component of this product.
- Patients with porphyria.
Warnings
Butalbital is habit-forming and potentially abusable. Consequently, the extended use of this product is not recommended.
Overdosage
Following an acute overdosage of butalbital, acetaminophen and caffeine, toxicity may result from the barbiturate or the acetaminophen. Toxicity due to caffeine is less likely, due to the relatively small amounts in this formulation.
Dosage And Administration
Oral: one tablet every four hours. 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.
How Supplied
Butalbital 50 mg, Acetaminophen 500 mg and Caffeine 40 mg Tablets are white, oblong, scored tablets; embossed "WW 115" .
They are supplied by Keltman Pharmaceuticals Inc. as follows:
| NDC | Strength | Quantity/Form | Color | Source Prod. Code |
| 68387-520-30 | 50 mg / 500 mg / 40 mg | 30 Tablets in a Plastic Bottle | WHITE | 0143-1115 |
| 68387-520-60 | 50 mg / 500 mg / 40 mg | 60 Tablets in a Plastic Bottle | WHITE | 0143-1115 |
| 68387-520-90 | 50 mg / 500 mg / 40 mg | 90 Tablets in a Plastic Bottle | WHITE | 0143-1115 |
| 68387-520-12 | 50 mg / 500 mg / 40 mg | 120 Tablets in a Plastic Bottle | WHITE | 0143-1115 |
Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature].
Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
Manufactured By:
West-ward Pharmaceutical Corp.
Eatontown, NJ 07724
This Product was Repackaged By Sandhills Packaging For:
Keltman Pharmaceuticals Inc.
1 Lakeland Square, Suite A
Flowood, MS 39232
United States
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