This medicine is an analgesic and nonsteroidal anti-inflammatory drug (NSAID) combination used for short term pain relief.
Follow the directions for using this medicine provided by your doctor. This medicine comes with a Medication Guide. Read it carefully. Ask your doctor, nurse, or pharmacist any questions that you may have about this medicine. THIS MEDICINE MAY BE TAKEN WITH FOOD if it upsets your stomach. STORE THIS MEDICINE at room temperature 77 degrees F (25 degrees C) away from heat, moisture, and light. Brief storage between 59 and 86 degrees F (15 and 30 degrees C) is permitted. 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.
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 sodium oxybate or if you have taken a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the past 14 days. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking anticoagulants (such as warfarin), salicylates (such as aspirin), corticosteroids (such as prednisone), heparin, selective serotonin reuptake inhibitors (SSRIs) (such as fluoxetine), antihistamines (such as diphenhydramine), barbiturates (such as phenobarbital), cimetidine, narcotic pain medicine (such as codeine), anticholinergics (such as benztropine), probenecid, tricyclic antidepressants (such as amitriptyline), naltrexone, rifampin, cyclosporine, lithium, methotrexate, quinolones (such as ciprofloxacin), angiotensin-converting enzyme (ACE) inhibitors (such as enalapril) or diuretics (such as furosemide or hydrochlorothiazide). DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor if you or a family member has a history of mental or mood problems, suicidal thoughts or attempts, or alcohol or substance abuse; or if you drink alcohol. Inform your doctor if you have a history of kidney, liver, or lung problems; diabetes; stomach or bowel problems (such as bleeding, perforation, ulcers); swelling or fluid buildup; lupus; asthma; growths in the nose (nasal polyps); or mouth inflammation. Inform your doctor of any other medical conditions including high blood pressure, blood disorders, bleeding or clotting problems, heart problems (such as heart failure), or blood vessel problems, or if you are at risk for any of these problems; Addison disease; thyroid problems; an enlarged prostate; trouble urinating; asthma or breathing problems; seizures; growths in the brain; a recent head injury; or if you have had recent surgery. Tell your doctor if you have poor health, dehydration or low fluid volume, low blood sodium levels, allergies, pregnancy, or breast-feeding. USE OF THIS MEDICINE IS NOT RECOMMENDED if you have had a severe allergic reaction (eg, severe rash, hives, trouble breathing, growths in the nose, dizziness) to aspirin or an NSAID (such as ibuprofen, celecoxib); severe diarrhea or other bowel problems caused by antibiotics or poisoning; severe kidney disease; if you have recently had or will be having 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 using this medicine.
SIDE EFFECTS that may occur while taking this medicine include anxiety, constipation, diarrhea, dizziness, dry mouth, gas, headache, heartburn, increased sweating, loss of appetite, nausea, nervousness, stomach pain or upset, trouble sleeping, vomiting, and weakness. If they continue or are bothersome, check with your doctor. CHECK WITH YOUR DOCTOR AS SOON AS POSSIBLE if you experience ringing in the ears. THIS MEDICINE MAY CAUSE SERIOUS STOMACH ULCERS OR BLEEDING. Taking it in high doses or for a long time, smoking, or drinking alcohol increases the risk of these side effects. Contact your doctor or emergency room at once if you develop severe stomach or back pain; black, tarry stools; vomit that looks like blood or coffee grounds; or unusual weight gain or swelling. CONTACT YOUR DOCTOR IMMEDIATELY if you experience bloody, black, or tarry stools; blurred vision; change in the amount of urine produced; chest pain; confusion; dark urine; depression; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; mental or mood changes; numbness of an arm or leg; one-sided weakness; red, swollen, blistered, or peeling skin; seizures; severe headache or dizziness; severe or persistent stomach pain or nausea; severe vomiting; shortness of breath; slow or shallow breathing; stiff neck; sudden or unexplained weight gain; swelling of hands, legs, or feet; unusual bruising or bleeding; unusual joint or muscle pain; vision or speech changes; and yellowing of the skin or eyes. AN ALLERGIC REACTION to this medicine is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash, itching, swelling, dizziness, or trouble breathing. 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 blurred vision, cold and clammy skin, coma, confusion, decreased urination, loss of consciousness, ringing in the ears, severe dizziness or drowsiness, severe muscle weakness, severe nausea or stomach pain, slow or troubled breathing, unusual bleeding or bruising, and vomit that looks like coffee grounds.
DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. DO NOT USE THIS MEDICINE for other health conditions. KEEP THIS MEDICINE out of the reach of children.