Acetaminophen/Butalbital/Caffeine Dosage

Usual Adult Dose for Headache

Acetaminophen 300 mg, butalbital 50 mg, and caffeine 40 mg:
1 or 2 capsule(s) orally every 4 hours as needed. Maximum daily dose: 6 doses.

Acetaminophen 325 mg, butalbital 50 mg, and caffeine 40 mg:
1 or 2 tablet(s), capsule(s), or tablespoonful(s) orally every 4 hours.
Maximum daily dose: 6 doses

Acetaminophen 500 mg, butalbital 50 mg, and caffeine 40 mg:
1 tablet or capsule orally every 4 hours.
Maximum daily dose: 6 doses

Acetaminophen 750 mg, butalbital 50 mg, and caffeine 40 mg:
1 tablet orally every 4 hours.
Maximum daily dose: 5 tablets

Usual Pediatric Dose for Headache

12 years and older:
Acetaminophen 300 mg, butalbital 50 mg, and caffeine 40 mg:
1 or 2 capsule(s) orally every 4 hours as needed. Maximum daily dose: 6 doses.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

Extended and repeated use of these products is not recommended because of the potential for physical dependence.

Dialysis

Data not available

Other Comments

The FDA has asked manufacturers to limit the maximum amount of acetaminophen in prescription products to 325 mg per dosage unit. There are no data that indicate that taking more than 325 mg of acetaminophen per dosage unit provides more pain relief. The goal of the FDA is to reduce the risk of severe liver injury from acetaminophen overdose, which can lead to liver failure, liver transplant, and even death. The total number of units that may be prescribed and the time intervals for dosing will not change. Drug companies will have until January 14, 2014 to comply with FDA requirements.

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