butalbital with aspirin-oral, Axotal (cont.)

SIDE EFFECTS: May cause lightheadedness, dizziness, drowsiness, stomach upset, nausea, and sleeping disturbances the first few days as your body adjusts to the medication. If these symptoms persist or worsen, inform your doctor. Notify your doctor if you develop: a rapid or irregular heartbeat, ringing in the ears, severe stomach pain, easy bruising or bleeding, black stools, yellowing eyes, dark urine. 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, asthma, nasal polyps, diabetes, stomach ulcers, bleeding disorders, any allergies. This medication contains aspirin. Children and teenagers should not take aspirin if they have chickenpox, influenza or any undiagnosed illness without first consulting a doctor about Reye's syndrome, a rare but serious illness. Elderly persons are usually more sensitive to the effects of this medication. Use cautiously. Use caution performing tasks requiring alertness if this medication makes you drowsy. Limit alcohol intake. 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 for details. This drug passes into breast milk and has had undesirable effects on nursing infants. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Tell your doctor of all prescription and nonprescription drugs you use, including: blood thinners (anticoagulants and antiplatelet drugs such as warfarin, heparin, NSAIDs), corticosteroids (e.g., prednisone), all pain medications, anti-seizure drugs, heart medications, medication for diabetes, drugs to treat gout, glaucoma medications, drugs which make you drowsy (sedatives, psychiatric medications, certain antihistamines), methotrexate, estrogen, beta-blockers (e.g., propranolol). This drug may interfere with the effectiveness of birth control pills. Discuss using other methods of birth control with your doctor. 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 or antihistamines in cough-and-cold products as well. 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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