Acetaminophen (a-seet-a-MIN-oh-fen), Butalbital (bue-TAL-bi-tal)

Treats the symptoms of tension headache. This medicine contains a barbiturate.

Brand Name(s):

Allzital, Bupap, Tencon

When This Medicine Should Not Be Used:

How to Use This Medicine:

Capsule, Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• This medicine contains acetaminophen. Read the labels of all other medicines you are using to see if they also contain acetaminophen, or ask your doctor or pharmacist. Do not use more than 4 grams (4,000 milligrams) total of acetaminophen in one day.
• This medicine is not for long-term use.
• If this medicine upsets your stomach, you may take it with food or milk.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how butalbital/acetaminophen works. Tell your doctor if you are using an MAO inhibitor or medicine to treat depression.
• Do not drink alcohol while you are using this medicine.
• Tell your doctor if you use anything else that makes you sleepy. Some examples are allergy medicine, narcotic pain medicine, and alcohol.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, stomach problems, or drug or alcohol addiction.
• This medicine may cause serious skin reactions (including acute generalized exanthematous pustulosis, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• This medicine may make you dizzy or drowsy. Do not drive or do anything that could be dangerous until you know how this medicine affects you.
• Do not stop using this medicine suddenly. Your doctor will need to slowly decrease your dose before you stop it completely.
• This medicine can be habit-forming. Do not use more than your prescribed dose. Call your doctor if you think your medicine is not working.
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, red skin rash
• Blue lips, fingernails, or skin
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Fast heartbeat
• Increase in how much or how often you urinate
• Numbness in any part of your body
• Severe confusion, lightheadedness, dizziness, fainting
• Trouble swallowing
• Unusual bleeding or bruising

If you notice these less serious side effects, talk with your doctor:

• Dry mouth, mild nausea, vomiting, constipation, stomach pain or upset
• Feeling like you are drunk
• Muscle pain or weakness
• Ringing in your ears
• Sleepiness

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088