PRECAUTIONS: Before taking this medication, tell your doctor or pharmacist if you are allergic to aspirin, caffeine, or butalbital; or to other barbiturates (e.g., phenobarbital), salicylates (e.g., salsalate), nonsteroidal anti-inflammatory drugs (e.g., ibuprofen), or xanthine derivatives (e.g., theophylline); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: severe breathing problems (e.g., bronchopneumonia), a certain enzyme disorder (porphyria), aspirin-sensitive asthma (a history of worsening breathing with runny/stuffy nose after taking aspirin or other NSAIDs), severe stomach/bowel problems (e.g., stomach/intestinal ulcers), bleeding/blood clotting disorders (e.g., hemophilia, von Willebrand's disease, thrombocytopenia).Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease, asthma, heartburn, gout, growths in the nose (nasal polyps), personal or family history of regular use/abuse of drugs/alcohol, certain enzyme deficiencies (pyruvate kinase or G6-PD deficiency), mental/mood disorders, heart disease (e.g., irregular heartbeat, recent heart attack).Before having surgery, tell your doctor or dentist that you are using this medication.This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.This medicine may cause stomach bleeding. Daily use of alcohol and tobacco, especially when combined with this medicine, may increase your risk for stomach bleeding. Limit alcohol and stop smoking. Consult your doctor or pharmacist for more information.This medication contains aspirin. Children and teenagers less than 18 years old should not take aspirin if they have chickenpox, flu, or any undiagnosed illness, or if they have just been given a live virus vaccine, without first consulting a doctor about Reye's syndrome, a rare but serious illness.Older adults may be more sensitive to the side effects of this drug, especially drowsiness, stomach/intestinal bleeding and ulcers, and trouble falling asleep. Drowsiness and trouble falling asleep can increase the risk of falling.This medication is not recommended for use during pregnancy. Consult your doctor for more details.This drug passes into breast milk and could have undesirable effects on a nursing infant. Therefore, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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