This medicine is a nonsteroidal anti-inflammatory drug (NSAID) used to treat rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, and juvenile arthritis. It is used to treat tendonitis, bursitis, gout, menstrual cramps, or mild to moderate pain. It may also be used for other conditions as determined by your doctor.
Follow the directions for using this medicine provided by your doctor. This medicine has a MEDICATION GUIDE approved by the U.S. Food and Drug Administration. Read it carefully. Ask your doctor, nurse, or pharmacist any questions that you may have about this medicine. SHAKE WELL before taking a dose. Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure this dose. TAKE THIS MEDICINE with a full glass (8-oz./240 ml) of water as directed by your doctor. THIS MEDICINE MAY BE TAKEN WITH FOOD if it upsets your stomach. Taking it with food may not decrease the risk of stomach or bowel problems (eg, bleeding, ulcers) that may occur while taking this medicine. Talk with your doctor or pharmacist if you experience persistent stomach upset. IF YOU TAKE ANTACIDS, CHOLESTYRAMINE, OR SUCRALFATE, ask your doctor or pharmacist how to take them with this medicine. STORE THIS MEDICINE at room temperature between 59 and 86 degrees F (15 and 30 degrees C) in a tightly-closed container, away from heat, moisture, and light. Avoid excessive heat above 104 degrees F (40 degrees C). KEEP THIS MEDICINE out of the reach of children and away from pets. IF YOU MISS A DOSE OF THIS MEDICINE and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
WARNING: This medicine is a nonsteroidal anti-inflammatory drug (NSAID). It may cause an increased risk of serious and sometimes fatal heart and blood vessel problems (eg, heart attack, stroke). The risk may be greater if you already have heart problems or if you take this medicine for a long time. Do not use this medicine right before or after bypass heart surgery. THIS MEDICINE MAY CAUSE an increased risk of serious and sometimes fatal stomach ulcers and bleeding. Elderly patients may be at greater risk. This may occur without warning signs. Some medicines or medical conditions may interact with this medicine. INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. DO NOT TAKE THIS MEDICINE if you are also taking another medicine that contains naproxen. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), anticoagulants (eg, warfarin), antiplatelet medicines (eg, clopidogrel, prasugrel), aspirin, beta-blockers (eg, propranolol), bisphosphonates (eg, alendronate), corticosteroids (eg, prednisone), cyclosporine, diuretics (eg, furosemide, hydrochlorothiazide), heparin, hydantoins (eg, phenytoin), lithium, methotrexate, probenecid, quinolones (eg, ciprofloxacin), rivaroxaban, selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine), sulfonamides (eg, sulfamethoxazole), sulfonylureas (eg, glipizide), or other NSAIDs (eg, ibuprofen). DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions, including poor health, dehydration, low fluid volume, low blood sodium levels, allergies, pregnancy, or breast-feeding. Tell your doctor if you have, or are at risk for, high blood pressure, blood disorders, bleeding or clotting problems, heart problems (eg, heart failure), or blood vessel disease. Tell your doctor if you have a history of alcohol abuse, kidney or liver disease, diabetes, stomach or bowel problems (eg, bleeding, perforation, ulcers), swelling or fluid buildup, asthma, growths in the nose (nasal polyps), or mouth inflammation. Tell your doctor if you drink alcohol, smoke, or are on a low salt (sodium) diet. USE OF THIS MEDICINE IS NOT RECOMMENDED if you are going to have or have recently had bypass heart surgery, or if you are in the last 3 months of pregnancy. Contact your doctor or pharmacist if you have any questions or concerns about taking this medicine.
SIDE EFFECTS that may occur while taking this medicine include upset stomach, nausea, heartburn, gas, headache, diarrhea, constipation, drowsiness, stuffy nose, or dizziness. If they continue or are bothersome, check with your doctor. CONTACT YOUR DOCTOR IMMEDIATELY if you experience bloody or black, tarry stools; change in the amount of urine produced; chest pain; confusion; dark urine; depression; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; loss of appetite; mental or mood changes; numbness of an arm or leg; one-sided weakness; pale stools; red, swollen, blistered, or peeling skin; ringing in the ears; seizures; severe headache, dizziness, or vomiting; severe or persistent stomach pain or nausea; shortness of breath; sudden or unexplained weight gain; swelling of hands, legs, or feet; unusual bruising or bleeding; unusual joint or muscle pain; unusual tiredness or weakness; vision or speech changes; vomit that looks like coffee grounds; or yellowing of the skin or eyes. AN ALLERGIC REACTION to this medicine is unlikely but seek immediately medical attention if it occurs. Symptoms of an allergic reaction include rash; hives; itching; trouble breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; or wheezing. If you notice other effects not listed above, contact your doctor, nurse, or pharmacist. This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your healthcare provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include decreased urination, loss of consciousness, seizures, severe dizziness or drowsiness, severe nausea or stomach pain, slow or troubled breathing, unusual bleeding or bruising, or vomit that looks like coffee grounds.
If your symptoms do not improve or if they become worse, check with your doctor. DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. DO NOT USE THIS MEDICINE for other health conditions. IF YOU WILL BE TAKING THIS MEDICINE FOR AN EXTENDED PERIOD OF TIME, be sure to obtain necessary refills before your supply runs out. CHECK WITH YOUR PHARMACIST about how to dispose of unused medicine.