Aspirin (AS-pir-in), Butalbital (bue-TAL-bi-tal), Caffeine (KAF-een)

Treats tension headaches. This medicine contains an NSAID and a barbiturate.

Brand Name(s):

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet, Capsule

• Your doctor will tell you how much medicine to use. Do not use more than directed. An overdose can be dangerous. Follow directions carefully so you do not get too much medicine at one time.
• This medicine is not for long-term use.
• This medicine works best if you take it at the first sign of headache or pain.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• 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.

• Do not use this medicine if you are using or have used an MAO inhibitor within the past 14 days.
• Some medicines can affect how this medicine works. Tell your doctor if you are taking any of the following:
  • 6-mercaptopurine, chlordiazepoxide, methotrexate, probenecid, sulfinpyrazone
  • Blood thinner (including warfarin)
  • Insulin or oral diabetes medicine
  • Other NSAID pain or arthritis medicine (including diclofenac, ibuprofen, naproxen, celecoxib)
  • Steroid medicine
• Tell your doctor if you use anything else that makes you sleepy. Some examples are allergy medicine, narcotic pain medicine, and alcohol.
• Do not drink alcohol while you are using this medicine.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant. Do not use this medicine during the later part of a pregnancy, unless your doctor tells you to.
• Tell your doctor if you are breastfeeding, or if you have kidney disease, liver disease, Addison disease, lung or breathing problems (including asthma), an enlarged prostate, trouble urinating, an underactive thyroid, Reye syndrome, stomach problems, or any kind of infection (including chickenpox, flu). Tell your doctor if you have a history of head injury, seizures, or a history of drug or alcohol abuse.
• This medicine may cause the following problems:
  • Stomach or bowel problems (including bleeding, ulcers, or perforation)
  • Serious skin reaction, including drug reaction with eosinophilia and systemic symptoms (DRESS)
• 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.
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.
• 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.
• Do not stop using this medicine suddenly. Your doctor will need to slowly decrease your dose before you stop it completely.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

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
• Change or loss of consciousness, hearing loss, pale, clammy skin, shakiness in the legs, arms, hands, or feet, trouble sleeping
• Chest tightness, trouble breathing
• Fast, slow, or pounding heartbeat
• Lightheadedness, dizziness, fainting

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

• Drowsiness
• Nausea, vomiting, constipation, passing gas

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