Aspirin, butalbital, and caffeine

You should not use this medicine if you have a stomach ulcer, severe liver disease, porphyria, a bleeding or blood clotting disorder, or if you are allergic to any NSAID.

Aspirin may cause stomach or intestinal bleeding, which can be fatal.

Stop using aspirin, butalbital, and caffeine and call your doctor at once if you have: black, bloody, or tarry stools, and coughing up blood or vomit that looks like coffee grounds.

Aspirin should not be given to a child or teenager who has a fever.

Butalbital may be habit-forming. Misuse of habit-forming medicine can cause addiction, overdose, or death.

Follow all directions on your prescription label. Never use aspirin, butalbital, and caffeine in larger amounts, or for longer than prescribed. Tell your doctor if the medicine seems to stop working as well in relieving your headache.

Butalbital may be habit-forming. Never share aspirin, butalbital, and caffeine with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.

Misuse of habit-forming medicine can cause addiction, overdose, or death. Selling or giving away this medicine is against the law.

If you need surgery, tell the surgeon ahead of time that you are using aspirin, butalbital, and caffeine. You may need to stop using the medicine for a short time.

Do not stop using this medicine suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using aspirin, butalbital, and caffeine.

Store at room temperature away from moisture and heat.

Keep track of the amount of medicine used from each new bottle. Aspirin, butalbital, and caffeine is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

Taking this medicine with other drugs that make you sleepy or slow your breathing can cause dangerous side effects or death. Ask your doctor before taking a sleeping pill, narcotic pain medicine, prescription cough medicine, a muscle relaxer, or medicine for anxiety, depression, or seizures.

You should not use aspirin, butalbital, and caffeine if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

Tell your doctor about all your current medicines and any you start or stop using, especially:

• mercaptopurine;

• methotrexate;

• probenecid;

• insulin or oral diabetes medicine;

• a blood thinner--warfarin, Coumadin, Jantoven; or

• steroid medicine--prednisone, dexamethasone, and others.

This list is not complete. Other drugs may interact with aspirin, butalbital, and caffeine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Feeling sleepy.
• Dizziness.
• Gas.
• Upset stomach or throwing up.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Use with caution

Administration advice:
-Take orally as needed
-Do not exceed 6 capsules per day

Storage requirements: Protect from light and moisture

General:
-Butalbital is a drug that may be abused; extended use is not recommended.

Monitoring:
-Monitor for potential abuse
-Monitor liver function tests in patients with severe hepatic disease
-Monitor renal function tests in patients with severe renal disease

Patient advice:
-Patients should be advised that this drug has the potential to cause physical and psychological dependence, and tolerance; patients should be instructed to take this drug as prescribed, in the amounts prescribed, and no more frequently than prescribed.
-Patients should understand that this drug contains aspirin and should not be taken by patients with an aspirin allergy.
-Patients should be advised to avoid alcohol use while taking this drug.
-Patients should be advised to avoid potentially hazardous tasks such as driving a car while taking this drug.
-Women of childbearing potential should be advised to speak to their healthcare provider if they become pregnant, intend to become pregnant, or are breastfeeding.

Aspirin, butalbital, and caffeine are excreted into human milk in small concentrations. The significance of the effects on nursing infants has not been reported, but due to the potential for serious adverse reactions in nursing infants, other agents may be preferred.

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Yes (aspirin); Yes (barbiturates); Yes (caffeine)