Acetaminophen and butalbital

Generic name: Acetaminophen And Butalbital
Drug class: Analgesic combinations

Usage of Acetaminophen and butalbital

Acetaminophen is a pain reliever and fever reducer.

Butalbital is a barbiturate. It relaxes muscle contractions involved in a tension headache.

Acetaminophen and butalbital is a combination medicine used to treat tension headaches. acetaminophen and butalbital 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, even if you took 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.

Acetaminophen and butalbital may cause serious side effects. Call your doctor at once if you have:

  • fast or pounding heartbeats;
  • a light-headed 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;
  • nausea, vomiting, stomach pain;
  • drunk feeling; or
  • feeling short of breath.
  • 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.

    Before taking Acetaminophen and butalbital

    You should not use this medicine if you are allergic to acetaminophen (Tylenol) or butalbital, or if you have porphyria.

    Tell your doctor if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You may not be able to take medicine that contains acetaminophen.

    Tell your doctor if you have ever had:

  • liver disease;
  • kidney disease;
  • a stomach or intestinal disorder; or
  • drug or alcohol addiction.
  • Older adults may be more sensitive to the effects of this medicine.

    It is not known whether acetaminophen and butalbital will harm an unborn baby. However, this medicine can cause seizures in a newborn if the mother takes the medicine late in pregnancy. Tell your doctor if you are pregnant or plan to become pregnant.

    You should not breast-feed while using acetaminophen and butalbital.

    Acetaminophen and butalbital is not approved for use by anyone younger than 18 years old.

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    How to use Acetaminophen and butalbital

    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.

    Warnings

    Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death.

    In rare cases, acetaminophen may cause a severe skin reaction. Stop taking acetaminophen and butalbital and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling.

    Acetaminophen and butalbital may be habit-forming. Misuse can cause addiction, overdose, or death.

    What other drugs will affect Acetaminophen and butalbital

    Using acetaminophen and butalbital with other drugs that slow your breathing can cause dangerous side effects or death. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

    Other drugs may affect acetaminophen and butalbital, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

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