Acetaminophen is a pain reliever and a fever reducer.

Butalbital is in a class of drugs called barbiturates that slow down your central nervous system (brain and nerve impulses) causing relaxation.

The combination, acetaminophen and butalbital, is used to treat tension (or muscle contraction) headaches.

Acetaminophen and butalbital may also be used for purposes other than those listed in this medication guide.

Take acetaminophen and butalbital exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose with a full glass of water.

Take acetaminophen and butalbital with food or milk if it upsets your stomach.

Never take more acetaminophen and butalbital than is prescribed for you. If your pain is not being adequately treated, talk to your doctor.

Do not share this medication with anyone else.

Store this medication at room temperature away from heat, moisture, and the reach of children.

Do not take acetaminophen and butalbital if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. Dangerous side effects could result.

Acetaminophen and butalbital may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, antihistamines, sedatives (used to treat insomnia), other pain relievers, anxiety medicines, and muscle relaxants. Tell your doctor about all medicines that you are taking, and do not take any medicine unless your doctor approves.

Many other medicines contain acetaminophen, especially over-the-counter pain, fever, cold, and allergy medications. Too much acetaminophen can be very dangerous.

Drugs other than those listed here may also interact with acetaminophen and butalbital. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

Use caution when driving, operating machinery, or performing other hazardous activities. Butalbital may cause drowsiness or dizziness. If you experience drowsiness or dizziness, avoid these activities.

Avoid sleeping pills, antihistamines, sedatives, and tranquilizers except under the supervision of your doctor. These may also make you drowsy.

Avoid alcohol. Alcohol taken during therapy with acetaminophen and butalbital can be very damaging to your liver and can increase drowsiness and dizziness.

Check the acetaminophen content of other over-the-counter and prescription products while taking this medication. You should not exceed 4 grams (4000 mg) of acetaminophen per day.

Seek emergency medical attention.

Symptoms of an acetaminophen and butalbital overdose include nausea, vomiting, diarrhea, abdominal pain, sweating, seizures, drowsiness, decreased breathing, dizziness or fainting, confusion, an irregular heartbeat, and coma.

Take the missed dose as soon as you remember. Do not take a double dose of this medication. Wait the prescribed amount of time before taking your next dose.

If you are taking acetaminophen and butalbital on an as-needed basis, missing a dose is not usually a problem. Take the missed dose as soon as you remember and do not take another dose for the amount of time prescribed.

Use caution when driving, operating machinery, or performing other hazardous activities. Butalbital will cause drowsiness or dizziness. If you experience drowsiness or dizziness, avoid these activities.

Avoid sleeping pills, antihistamines, sedatives, and tranquilizers except under the supervision of your doctor. These may also make you drowsy.

Avoid alcohol. Alcohol taken during therapy with acetaminophen and butalbital can be very damaging to your liver and can increase drowsiness and dizziness.

Check the acetaminophen content of other over-the-counter and prescription products while taking this medication. You should not exceed 4 grams (4000 mg) of acetaminophen per day.

Never take more acetaminophen and butalbital than is prescribed for you. If your pain is not being adequately treated, talk to your doctor.

This medication is habit forming and should only be used under close supervision. Take this drug only for as long as it is prescribed , in the amounts it is prescribed, and no more frequently than prescribed.

Do not take acetaminophen and butalbital without first talking to your doctor if you drink more than three alcoholic beverages per day or if you have had alcoholic liver disease. You may not be able to take acetaminophen and butalbital, or you may require a lower dose.

Do not take acetaminophen and butalbital if you have porphyria.

Before taking this medication, tell your doctor if you have

• kidney disease, or

• liver disease.

You may not be able to take acetaminophen and butalbital, or you may require a lower dose or special monitoring during treatment if you have any of the conditions listed above.

Acetaminophen and butalbital is in the FDA pregnancy category C. This means that it is not known whether this combination will harm an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant.

Acetaminophen and butalbital both pass into breast milk and may harm a baby. Do not take this medication without first talking to your doctor if you are breast-feeding a baby.

Acetaminophen and butalbital has not been approved for use in children younger than 12 years of age.

Your pharmacist has additional information about acetaminophen and butalbital written for health professionals that you may read.

Acetaminophen and butalbital is available with a prescription under several brand and generic names. Ask your pharmacist any questions you have about this medication especially if it is new to you.