Butalbital, Acetaminophen And Caffeine
FDA Label NDC 68387-520

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Keltman Pharmaceuticals Inc. for the product Butalbital, Acetaminophen And Caffeine (NDC 68387-520). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding description, clinical pharmacology, indications and usage, contraindications, warnings, overdosage, dosage and administration, how supplied, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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:

Figure 1 (Bact 01)

Figure 1 (Bact 01)

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:

Figure 2 (Bact 02)

Figure 2 (Bact 02)

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:

Figure 3 (Bact 03)

Figure 3 (Bact 03)

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:

NDCStrengthQuantity/FormColorSource Prod. Code
68387-520-3050 mg / 500 mg / 40 mg30 Tablets in a Plastic BottleWHITE0143-1115
68387-520-6050 mg / 500 mg / 40 mg60 Tablets in a Plastic BottleWHITE0143-1115
68387-520-9050 mg / 500 mg / 40 mg90 Tablets in a Plastic BottleWHITE0143-1115
68387-520-1250 mg / 500 mg / 40 mg120 Tablets in a Plastic BottleWHITE0143-1115

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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