floctafenine-oral tablet (cont.)

PRECAUTIONS: Tell your doctor your medical history, especially of: liver or kidney disease, blood disorders, ulcers, heart disease, alcohol use, high blood pressure, eye disease, allergies (especially drug allergies). Use caution when performing tasks requiring alertness. Limit alcohol intake as it may intensify the drowsiness effect of this medication. 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. Do not take aspirin without consulting your doctor. Check the ingredients of any nonprescription medication you may be taking since many cough-and-cold formulas contain aspirin. Infrequently, this medication may increase the skin's sensitivity to sunlight. If this happens to you, avoid prolonged sun exposure, wear protective clothing and use a sunscreen. Avoid sunlamps. Caution is advised when this drug is used in the elderly. This medication should be used during pregnancy only if clearly needed. Discuss the risks and benefits with your doctor. Use of this drug during the last 6 months of pregnancy is not recommended. This drug is excreted into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Tell your doctor of all prescription and nonprescription medication you may use, especially of: other NSAID (e.g., aspirin, ibuprofen), warfarin ("blood thinners"), water pills (diuretics), high blood pressure drugs, antidiabetic drugs (e.g., chlorpropamide, tolazamide), sulfa drugs, phenytoin, lithium, certain cancer drugs such as methotrexate, corticosteroids (e.g., prednisone). Also mention drugs that make you drowsy such as: sleeping pills, sedatives, tranquilizers, narcotic pain relievers (e.g., codeine), anxiety medicine, certain antihistamines (e.g., diphen- hydramine), muscle relaxants. 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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