Acetaminophen and butalbital

Name: Acetaminophen and butalbital

What is acetaminophen and butalbital?

Acetaminophen is a pain reliever and fever reducer.

Butalbital is in a group of drugs called barbiturates. It relaxes muscle contractions involved in a tension headache.

Acetaminophen and butalbital is a combination medicine used to treat tension headaches. This medicine is not for treating headaches that come and go.

Acetaminophen and butalbital may also be used for purposes not listed in this medication guide.

Acetaminophen and butalbital side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

In rare cases, acetaminophen may cause a severe skin reaction that can be fatal. This could occur even if you have taken acetaminophen in the past and had no reaction. Stop taking this medicine and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling. If you have this type of reaction, you should never again take any medicine that contains acetaminophen.

Call your doctor at once if you have:

  • fast or pounding heart rate, feeling short of breath;

  • feeling like you might pass out;

  • confusion, depression;

  • feeling restless, excited, or agitated;

  • seizure (convulsions); or

  • liver problems--nausea, upper stomach pain, itching, tiredness, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects include:

  • headache, dizziness, drowsiness, shaky feeling;

  • drunk feeling;

  • vomiting, constipation;

  • heartburn, trouble swallowing;

  • numbness or tingly feeling;

  • dry mouth;

  • sweating or urinating more than usual;

  • leg pain, tired muscles;

  • stuffy nose, ear pain, ringing in your ears; or

  • mild itching.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Acetaminophen and butalbital dosing information

Usual Adult Dose for Headache:

Butalbital 50 mg/acetaminophen 300 or 325 mg:
1 or 2 tablets orally every 4 hours as needed not to exceed 6 tablets per day

Butalbital 25 mg/acetaminophen 325 mg:
2 tablets orally every 4 hours as needed not to exceed 12 tablets per day

Comments:
-Due to high rate of physical dependence, the extended use of this drug is not recommended.
-The safety and efficacy of treating multiple recurrent headaches with this product is not known.

Uses: For the relief of the symptom complex of tension (or muscle contraction) headache.

Usual Pediatric Dose for Headache:

12 years or older:
Butalbital 50 mg/acetaminophen 300 or 325 mg:
1 or 2 tablets orally every 4 hours as needed not to exceed 6 tablets per day

Butalbital 25 mg/acetaminophen 325 mg:
2 tablets orally every 4 hours as needed not to exceed 12 tablets per day

Comments:
-Due to high rate of physical dependence, the extended use of this drug is not recommended.
-The safety and efficacy of treating multiple recurrent headaches with this product is not known.

Uses: For the relief of the symptom complex of tension (or muscle contraction) headache.

Usual Pediatric Dose for Headache

12 years or older:
Butalbital 50 mg/acetaminophen 300 or 325 mg:
1 or 2 tablets orally every 4 hours as needed not to exceed 6 tablets per day

Butalbital 25 mg/acetaminophen 325 mg:
2 tablets orally every 4 hours as needed not to exceed 12 tablets per day

Comments:
-Due to high rate of physical dependence, the extended use of this drug is not recommended.
-The safety and efficacy of treating multiple recurrent headaches with this product is not known.

Uses: For the relief of the symptom complex of tension (or muscle contraction) headache.

Liver Dose Adjustments

Use with caution

Bottom Line

Butalbital/acetaminophen is an effective pain reliever for the short-term treatment of tension-type headaches. However, it is sedating and potentially habit forming and should not be used repeatedly. Simpler and safer analgesics or analgesic combinations are preferred.

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