This medicine is a narcotic pain reliever and salicylate combination. This medicine is used for treating moderate to moderately severe pain.
Follow the directions for taking this medicine provided by your doctor. TAKE THIS MEDICINE by mouth with or without food. It may be taken with food if it upsets your stomach. Taking it with food may not lower the risk of stomach or bowel problems (eg, bleeding, ulcers). Talk with your doctor or pharmacist if you have persistent stomach upset. DO NOT change your dose or suddenly stop taking this medicine without first checking with your doctor. IF THIS MEDICINE IS NO LONGER NEEDED, dispose of it as soon as possible. Ask your doctor or pharmacist how to dispose of this medicine properly. STORE THIS MEDICINE at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. KEEP THIS MEDICINE out of reach of children and 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.
SOME MEDICINES MAY INTERACT with this medicine. DO NOT TAKE THIS MEDICINE if you are taking sodium oxybate (GHB) or ketorolac. TELL YOUR HEALTH CARE PROVIDER if you are taking any other medicines, especially any of the following: anticoagulants (eg, heparin, warfarin, enoxaparin), clopidogrel, dabigatran, desirudin, NSAIDs (eg, ibuprofen), rivaroxaban, selective serotonin reuptake inhibitors (SSRIs) (eg, citalopram), certain antinausea medicines (eg, metoclopramide), azole antifungals (eg, ketoconazole), cimetidine, HIV protease inhibitors (eg, ritonavir), macrolide antibiotics (eg, clarithromycin), muscle relaxants (eg, cyclobenzaprine), narcotic pain relievers (eg, codeine), nefazodone, phenothiazines (eg, chlorpromazine), telithromycin, mixed narcotic agonists/antagonists (eg, buprenorphine, butorphanol, nalbuphine, pentazocine), naltrexone, rifamycins (eg, rifampin), carbonic anhydrase inhibitors (eg, acetazolamide), insulin, methotrexate, oral diabetes medicines (eg, glyburide, repaglinide), phenytoin, valproic acid, angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), beta-blockers (eg, propranolol), diuretics (eg, furosemide, hydrochlorothiazide), probenecid, or sulfinpyrazone. This may not be a complete list of all interactions that may occur. Ask your health care provider if this medicine may interact with other medicines you take. DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions, including blood problems (eg, porphyria); bleeding or clotting problems; low levels of vitamin K in the blood; chickenpox or flu symptoms; hives; Kawasaki syndrome; a rheumatic condition; severe drowsiness; poor health; if you will be having surgery; allergies, especially to other narcotic pain relievers (eg, morphine, codeine, hydromorphone); pregnancy; or breast-feeding;. Tell your doctor if you have a history of constipation; lung or breathing problems (eg, asthma, emphysema, bronchitis, chronic obstructive pulmonary disease / COPD); sleep apnea (you stop breathing when you sleep); curvature of the spine (eg, kyphoscoliosis); heart problems (eg, cor pulmonale); low blood pressure; dehydration; low blood volume; shock caused by heart problems; recent head injury; growths in the brain (eg, tumors, lesions); an enlarged blood vessel in the brain (eg, aneurysm); increased pressure in the brain; stroke; seizures (eg, epilepsy); kidney or liver problems; thyroid problems; stomach or bowel problems (eg, ulcers, inflammation, recent surgery); pancreas or gallbladder problems; adrenal problems (Addison disease); an enlarged prostate; blockage of your bladder; trouble urinating; mood or mental problems (eg, depression, hallucinations); suicidal thoughts or behavior; alcohol or other substance abuse; regular alcohol use; or you are in alcohol withdrawal. USE OF THIS MEDICINE IS NOT RECOMMENDED if you have known or suspected bowel blockage (paralytic ileus); severe or persistent diarrhea caused by antibiotics; moderate to severe breathing problems; or severe asthma. USE OF THIS MEDICINE IS NOT RECOMMENDED if you are having an asthma attack or you have severe bleeding. USE OF THIS MEDICINE IS NOT RECOMMENDED if you have a history of asthma symptoms (eg, shortness of breath, wheezing), nasal swelling, or growths in the nose caused by aspirin; certain bleeding problems (eg, hemophilia, von Willebrand disease); low blood platelet levels; or stomach ulcers. USE OF THIS MEDICINE IS NOT RECOMMNEDED in children or teenagers with a viral infection (eg, chickenpox, flu symptoms). This medicine should not be used in CHILDREN; safety and effectiveness in children have not been confirmed. 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: constipation; dizziness; drowsiness; heartburn; lightheadedness; nausea; stomach upset; vomiting. If they continue or are bothersome, check with your doctor. SEEK MEDICAL ATTENTION RIGHT AWAY if any of these SEVERE side effects occur: bloody or black stools; confusion; dark urine; decreased or difficult urination; fainting; fast, slow, or irregular heartbeat; fever, chills, or persistent sore throat; hallucination; hearing loss; mood or mental changes; muscle pain, weakness, or cramps; one-sided weakness; ringing in the ears; seizures; severe dizziness, drowsiness, headache, or lightheadedness; severe or persistent constipation, heartburn, or stomach pain; shortness of breath; slow or shallow breathing; trouble swallowing; unusual bruising or bleeding; vision or speech problems; vomit that looks like coffee grounds; wheezing; 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; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness. This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care 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 may include chest pain; cold and clammy skin; coma; confusion; dehydration; depression; enlarged or decreased pupil size; fever; loss of consciousness; ringing in the ears or trouble hearing; severe drowsiness, dizziness, lightheadedness, nausea, vomiting, or diarrhea; severe weakness; slow, shallow, or difficult breathing; slow heartbeat.
If your symptoms do not improve or if they become worse, check with your doctor. IF YOU ARE TAKING ASPIRIN PRESCRIBED BY YOUR DOCTOR TO PREVENT HEART ATTACK OR STROKE, check with your doctor to see whether you should continue to take it with this medicine. THIS MEDICINE MAY CAUSE OR WORSEN CONSTIPATION. To prevent constipation, maintain a diet adequate in fiber, drink plenty of water, and exercise. If you become constipated while taking this medicine, talk with your doctor or pharmacist. DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. DO NOT USE THIS MEDICINE for other health conditions.