SIDE EFFECTS: Stomach upset, drowsiness, dizziness or lightheadedness may occur. Headache, blurred vision, and constipation have also been reported. If any of these effects persist or worsen, inform your doctor promptly. Unlikely but notify your doctor promptly if you develop: vomiting, black stools, hearing problems, dark urine, yellowing eyes, easy bruising or bleeding, mental confusion, depression. In the unlikely event you have a serious allergic reaction to this drug, seek immediate medical attention. Symptoms of a serious allergic reaction include: rash, itching, swelling, severe dizziness, breathing trouble. If you notice other effects not listed above, contact your doctor or pharmacist.

PRECAUTIONS: Tell your doctor your medical history, especially of: kidney or liver disease, ulcers/intestinal disease, thyroid disease, Addison's disease, prostate or urinary trouble, a history of drug dependency, asthma, nasal polyps, bleeding disorders, any allergies. Because this medication contains aspirin, children and teenagers should not take this drug if they have chickenpox, influenza or any undiagnosed illness without first consulting a doctor about Reye's syndrome, a rare but serious illness. Use caution performing tasks requiring alertness if this medication causes you to feel drowsy. Limit alcohol intake. To avoid dizziness and lightheadedness when rising from a seated or lying position, get up slowly. This medicine may cause stomach bleeding. Daily use of alcohol, especially when combined with this medicine, may increase your risk for stomach bleeding. Check with your doctor or pharmacist for more information. Aspirin is not recommended for use during pregnancy. Consult your doctor before using this medication. This medication is excreted into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Tell your doctor of all over-the-counter and prescription medication you use, including: antidepressants, anti-anxiety drugs, anti-seizure drugs, other narcotic pain relievers, non-narcotic pain medications, sleeping pills, sedatives, blood thinners (anticoagulants and antiplatelet drugs such as warfarin, heparin, NSAID), corticosteroids (e.g., prednisone), methotrexate, cimetidine. Aspirin is an ingredient in many over-the-counter products. To prevent an overdose of aspirin, read the labels carefully before taking other pain relievers or cold products to be sure they do not contain aspirin. Consult your pharmacist if you are uncertain your over-the-counter products contain aspirin. This medication contains caffeine. Avoid drinking large amounts of caffeinated beverages while taking this medication as excessive nervousness and irritability can occur. Do not start or stop any medicine without doctor or pharmacist approval.

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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