Butalbital Compound

Butalbital Compound

Butalbital Compound Recall

Get an alert when a recall is issued.

Questions & Answers

Side Effects & Adverse Reactions

Drug Dependency:

Prolonged use of barbiturates can produce drug dependence, characterized by psychic dependence, and less frequently, physical dependence and tolerance. The abuse liability of butalbital, aspirin, and caffeine is similar to that of other barbiturate-containing drug combinations. Caution should be exercised when prescribing medication for patients with a known propensity for taking excessive quantities of drugs, which is not uncommon in patients with chronic tension headache.

Use in Ambulatory Patients:

Butalbital, aspirin, and caffeine may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a car or operating machinery. The patient should be cautioned accordingly. Central Nervous System depressant effects of butalbital may be additive with those of other CNS depressants. Concurrent use with other sedative-hypnotics or alcohol should be avoided. When such combined therapy is necessary, the dose of one or more agents may need to be reduced.

Use in Pregnancy:

Adequate studies have not been performed in animals to determine whether this drug affects fertility in males or females, has teratogenic potential, or has other adverse effects on the fetus. While there are no well-controlled studies in pregnant women, over twenty years of marketing and clinical experience does not include any positive evidence of adverse effects on the fetus. Although there is no clearly defined risk, such experience cannot exclude the possibility of infrequent or subtle damage to the human fetus. Butalbital, aspirin, and caffeine should be used in pregnant women only when clearly needed.

Nursing Mothers:

The effects of butalbital, aspirin, and caffeine on infants of nursing mothers are not known. Salicylates and barbiturates are excreted in the breast milk of nursing mothers. The serum levels in infants are believed to be insignificant with therapeutic doses.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.


Butalbital, aspirin, 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 butalbital, aspirin, and caffeine in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.


There is currently no drug history available for this drug.

Other Information

Each Butalbital, Aspirin, and Caffeine tablet for oral administration contains:

Butalbital, USP             50 mg

Aspirin, USP              325 mg

Caffeine, USP             40 mg

Butalbital, 5-allyl-5-isobutyl-barbituric acid, a white odorless crystalline powder; is a short-to intermediate-acting barbiturate. Its structural formula is as follows:

                  Butalbital structural formula

Aspirin, salicylic acid acetate, is a non-opiate analgesic, anti-inflammatory and antipyretic agent. It occurs as a white, crystalline tabular or needle-like powder and is odorless or has a faint odor. Its structural formula is as follows:

                  salicylic acid acetate structural formula

Caffeine, 1,3,7-trimethylxanthine, is a central nervous system stimulant which occurs as a white powder or white glistening needles. It also has a bitter taste. Its structural formula is as follows:

                  Caffeine structural formula

Inactive Ingredients: Hydrogenated Vegetable Oil, Microcrystalline Cellulose, Sodium Starch Glycolate, Starch 1500 and Talc.

Butalbital Compound Manufacturers

  • Major Pharmaceuticals
    Butalbital Compound (Bultabital, Aspirin And Caffeine) Tablet [Major Pharmaceuticals]

Login To Your Free Account