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.

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.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed. An acetaminophen overdose can damage your liver or cause death. Tell your doctor if you feel an increased urge to take more of acetaminophen and butalbital.

Acetaminophen and butalbital may be habit-forming. Misuse can cause addiction, overdose, or death. Selling or giving away this medicine is against the law.

This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using acetaminophen and butalbital.

If you need surgery, tell your surgeon you currently use this medicine. You may need to stop for a short time.

Do not stop using acetaminophen and butalbital suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using this medicine.

Store at room temperature away from moisture and heat.

Keep track of your medicine. Acetaminophen and butalbital is a drug of abuse and you should be aware if anyone is using it improperly or without a prescription.

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.

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.

Since this medicine is used for pain, you are not likely to miss a dose. Skip any missed dose if it is almost time for your next dose. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of acetaminophen and butalbital can be fatal.

The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.

Overdose symptoms may also include extreme drowsiness, confusion, fainting, shallow breathing, or no breathing.

Avoid driving or operating machinery until you know how acetaminophen and butalbital will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Ask a doctor or pharmacist before using any other medicine that may contain acetaminophen (sometimes abbreviated as APAP). Taking too much acetaminophen can lead to a fatal overdose.

Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen.

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.

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.