Migraine and headache:

Indications for: Butalbital/Acetaminophen/Caffeine

Tension (or muscle contraction) headache.

Adult Dosage:

1–2 tabs or caps every 4hrs as needed; max 6 daily. Not recommended for extended or repeated use.

Children Dosage:

<12yrs: not established.

Butalbital/Acetaminophen/Caffeine Contraindications:


Boxed Warning:


Butalbital/Acetaminophen/Caffeine Warnings/Precautions:

Increased risk of acute liver failure esp. in those with underlying liver disease and concomitant alcohol. Discontinue at the 1st sign of skin rash or any other hypersensitivity. Drug abusers. Severe hepatic or renal impairment (monitor). Acute abdominal conditions.  Elderly. Debilitated. Pregnancy (Cat.C). Nursing mothers: not recommended.

Butalbital/Acetaminophen/Caffeine Classification:

Barbiturate + analgesic + methylxanthine.

Butalbital/Acetaminophen/Caffeine Interactions:

May potentiate effects of alcohol, general anesthetics, tranquilizers, sedative-hypnotics, or other CNS depressants or narcotic analgesics; avoid. MAOIs may enhance CNS effects of butalbital. May cause false (+) urine test for 5-hydroxyindoleacetic acid.

Adverse Reactions:

Drowsiness, lightheadedness, dizziness, sedation, shortness of breath, nausea, vomiting, abdominal pain, intoxicated feeling; hepatotoxicity (APAP doses >4g/day); rare: serious skin reactions (eg, acute generalized exanthematous pustulosis [AGEP], Stevens-Johnson Syndrome [SJS], toxic epidermal necrolysis [TEN]), hypersensitivity.


Formerly known under the brand name Esgic or Fioricet.


Acetaminophen: Acetaminophen is principally by liver metabolism (conjugation).

Caffeine:  Caffeine is mainly metabolized by CYP1A2. Other enzymes, including CYP2E1, CYP3A4, CYP2C8 and CYP2C9 may play a minor role in its metabolism. Hepatic biotransformation prior to excretion results in about equal amounts of 1methylxanthine and 1-methyluric acid.

Drug Elimination:

Acetaminophen: The plasma half-life is 1.25 to 3 hours, but may be increased by liver damage and following overdosage. Elimination of acetaminophen is principally by liver metabolism (conjugation) and subsequent renal excretion of metabolites. Approximately 85% of an oral dose appears in the urine within 24 hours of administration, most as the glucuronide conjugate, with small amounts of other conjugates and unchanged drug. 

Butalbital: Elimination of butalbital is primarily via the kidney (59% to 88% of the dose) as unchanged drug or metabolites. The plasma half-life is about 35 hours. Urinary excretion products included parent drug (about 3.6% of the dose), 5-isobutyl-5-(2, 3- dihydroxypropyl) barbituric acid (about 24% of the dose), 5-allyl-5(3-hydroxy-2-methyl1-propyl) barbituric acid (about 4.8% of the dose), products with the barbituric acid ring hydrolyzed with excretion of urea (about 14% of the dose), as well as unidentified materials. Of the material excreted in the urine, 32% was conjugated. 

Caffeine: Caffeine is cleared rapidly through metabolism and excretion in the urine. The plasma half-life is about 3 hours. Of the 70% of the dose that has been recovered in the urine, only 3% was unchanged drug.

How Supplied:

Contact supplier