What is aspirin, butalbital, caffeine, and codeine?

Aspirin is in a group of drugs called salicylates (sa-LIS-il-ates). It works by reducing substances in the body that cause pain, fever, and inflammation.

Butalbital is in a group of drugs called barbiturates. It relaxes muscle contractions involved in a tension headache.

Caffeine is a central nervous system stimulant. It relaxes muscle contractions in blood vessels to improve blood flow.

Codeine is in a group of drugs called narcotic pain relievers.

The combination of aspirin, butalbital, caffeine, and codeine is used to treat tension headaches. This medicine is not for treating headaches that come and go.

This medication may also be used for purposes other than those listed in this medication guide.

What should I discuss with my healthcare provider before taking aspirin, butalbital, caffeine, and codeine?

Aspirin can cause a serious and sometimes fatal condition called Reye's syndrome in children. Do not use this medication if you are allergic to aspirin, butalbital, caffeine, or codeine, or if you have:

• porphyria;

• stomach ulcer;

• a bleeding or blood clotting disorder; or

• an allergy to an NSAID (non-steroidal anti-inflammatory drug) such as Advil, Motrin, Aleve, Orudis, Indocin, Lodine, Voltaren, Toradol, Mobic, Relafen, Feldene, and others.

Codeine and butalbital may be habit-forming and should be used only by the person this medicine was prescribed for. This medication should never be given to another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.

Before using aspirin, butalbital, caffeine, and codeine, tell your doctor if you are allergic to any drugs, or if you have:

• a history of heart attack, stroke, blood clot, or stomach ulcers;

• asthma or other breathing disorders;

• liver or kidney disease;

• a history of head injury or brain tumor;

• low blood pressure;

• a stomach or intestinal disorder;

• curvature of the spine; or

• mental illness, or a history of drug or alcohol addiction.

If you have any of these conditions, you may not be able to use aspirin, butalbital, caffeine, and codeine, or you may need a dosage adjustment or special tests during treatment.

FDA pregnancy category C. Codeine and butalbital may be harmful to an unborn baby, and could cause a birth defect, breathing problem, or addiction/withdrawal symptoms in a newborn. Taking aspirin during late pregnancy may cause bleeding in the mother or the baby during delivery. Do not take aspirin during pregnancy unless your doctor has told you to. Aspirin, butalbital, caffeine, and codeine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

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