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HYDROCODONE-IBUPROFEN-ORAL (cont.)

PRECAUTIONS: Tell your doctor your medical history, especially of: allergies (especially drug allergies), asthma, nasal polyps, recent head injury, brain disorders (e.g., cancer), stomach/intestinal ulcers, high blood pressure, blood disorders, alcoholism, current smoking, kidney problems, lung diseases, heart problems, liver disease, diabetes, thyroid problems (hypothyroid), enlarged prostate (males), urinary problems, any allergies - especially aspirin/NSAID allergy (e.g., ibuprofen, celecoxib). Use caution when performing tasks requiring alertness or when using 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. This medication should be used only when clearly needed during pregnancy. Avoid use toward the end of pregnancy (last three months) because it may harm the fetus. Discuss the risks and benefits with your doctor. It is not known if this drug is excreted into breast milk. Because of the potential risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding. Caution is advised when this product is used in the elderly.

DRUG INTERACTIONS: Tell your doctor of all nonprescription and prescription medication you may use, especially of: blood pressure medicine (including ACE inhibitors such as lisinopril or enalapril), anticholinergics/antihistamines such as diphenhydramine or propantheline, antidepressants, MAO inhibitors (e.g., linezolid, selegiline, furazolidone, tranylcypromine, phenelzine), tricyclics (e.g., amitriptyline), aspirin or other NSAIDs such as naproxen, "blood-thinners" such as warfarin or heparin, "water pills" (diuretics), lithium, methotrexate, other narcotic pain relievers such as codeine, corticosteroids (e.g., prednisone), cimetidine. Also report the use of drugs that cause drowsiness such as: anti-seizure drugs, anti-anxiety drugs, muscle relaxants, psychiatric drugs, sedatives, sleeping pills. Certain cough-and-cold and pain reliever medicines contain narcotics (e.g., codeine) or aspirin-like pain relievers (NSAIDs) which are very similar to the drugs in this product. 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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