Aspirin is a pain reliever, as well as an anti-inflammatory and a fever reducer.

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

Caffeine is believed to constrict dilated blood vessels (veins and arteries) that may contribute to tension headaches.

Aspirin/butalbital/caffeine is used to relieve complex tension headaches, although precisely how it works is unknown.

Aspirin/butalbital/caffeine may also be used for purposes other than those listed in this medication guide.

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 alcohol. Alcohol taken during therapy with aspirin/butalbital/caffeine can increase the risk of stomach bleeding and can increase drowsiness and dizziness.

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

Avoid other over-the-counter and prescription products that contain aspirin. Too much aspirin could be dangerous. Talk to your doctor or pharmacist before taking any over-the-counter preparations.

Do not take aspirin/butalbital/caffeine without first talking to your doctor if you drink more than three alcoholic beverages per day, if you have a stomach ulcer, if you have a bleeding or platelet disorder, or if you have recently had surgery.

Before taking this medication, tell your doctor if you have

• kidney disease;

• liver disease;

• porphyria;

• asthma or another respiratory disease;

• fluid retention;

• congestive heart disease or another type of heart disease; or

• high blood pressure.

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

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

Aspirin/butalbital/caffeine passes into breast milk and may harm a nursing infant. Do not take this medication without first talking to your doctor if you are breast-feeding a baby.

If you are older than 60 years of age, you may be more likely to experience side effects from this medication. Use extra caution.

Do not use aspirin/butalbital/caffeine to treat a child or teenager who has a fever, flu symptoms, or chicken pox without first talking to a doctor. In children younger than 20 years of age, aspirin may increase the risk of Reye's syndrome, a rare but often fatal condition.