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CODEINE/ASPIRIN/CAFFEINE/BUTALBITAL-ORAL (cont.)

PRECAUTIONS: Tell your doctor your medical history, especially of: kidney or liver disease, asthma, nasal polyps, diabetes, stomach ulcers, bleeding disorders, depression, any allergies - especially aspirin/NSAID allergy (e.g., ibuprofen, celecoxib). 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 engaging in activities requiring alertness such as driving or operating machinery. 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 before using this medication. This drug is excreted into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: This medication can interact with many drugs. Before you take it, tell your doctor of all over-the-counter and prescription drugs you may use, including: "blood thinners" (e.g., warfarin, heparin, ticlopidine), NSAIDs (e.g., ibuprofen), steroids (e.g., prednisone-like drugs), anti-seizure medication, heart medications, certain diabetes drugs (e.g., glyburide, metformin), drugs to treat gout, glaucoma drugs, sleeping pills, sedatives, tranquilizers, muscle relaxants, medication for depression, narcotic and non-narcotic pain medication, cimetidine. Also tell your doctor if you take: methotrexate, estrogens, beta-blockers (e.g., metoprolol, propranolol). 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. This drug may interfere with the effectiveness of birth control pills. Discuss using other methods of birth control with your doctor. Do not start or stop any medicine without doctor or pharmacist approval.




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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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