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Drug Information For:


Ingredient Name:

OXYCODONE (ox-i-KOE-done) and ACETAMINOPHEN (a-seat-a-MIN-oh-fen)

Drug Manufacturer:


Common Uses:

This medicine is a narcotic and analgesic combination used to relieve moderate to moderately severe pain. It may also be used to treat other conditions as determined by your doctor.

Before Using This Medicine:

WARNING: THIS MEDICINE CONTAINS ACETAMINOPHEN. Severe and sometimes fatal liver problems, including the need for liver transplant, have been reported with the use of acetaminophen. Most cases of these liver problems occurred in patients taking excessive doses of acetaminophen (more than 4,000 mg per day). Also, patients who developed these liver problems were often using more than 1 medicine that contained acetaminophen. Discuss any questions or concerns with your doctor. 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 (GHB). ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking other medicines for pain, anticholinergics (eg, scopolamine, oxybutynin), anticoagulants (eg, warfarin), azole antifungals (eg, itraconazole, ketoconazole), beta blockers (eg, propranolol), buprenorphine, butorphanol, cimetidine, clarithromycin, isoniazid, lamotrigine, loop diuretics (eg, furosemide), muscle relaxants (eg, cyclobenzaprine), nalbuphine, naltrexone, nefazodone, pentazocine, phenothiazines (eg, chlorpromazine), protease inhibitors (eg, boceprevir, ritonavir), rifamycins (eg, rifampin), sulfinpyrazone, telithromycin, zidovudine, or medicines that may harm the liver (eg, methotrexate, certain medicine for HIV infection). Ask your doctor if you are unsure if any of your medicines may harm the liver. DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions, including very poor health, dehydration or low blood volume, drowsiness, stomach pain, severe diarrhea caused by antibiotic use (pseudomembranous colitis), allergies, pregnancy, or breast-feeding. TELL YOUR DOCTOR if you have a history of asthma, chronic obstructive pulmonary disease (COPD), or other lung or breathing problems; heart problems (eg, cor pulmonale); low blood pressure; the blood disease porphyria; stomach or bowel problems (eg, blockage, paralysis); pancreatitis; gallbladder problems; liver problems (eg, hepatitis); kidney problems; seizures; thyroid problems; adrenal gland problems (eg, Addison disease); curvature of the spine (scoliosis); prostate problems (eg, an enlarged prostate); trouble urinating; drug or alcohol abuse; mood or mental problems; or suicidal thoughts or actions. TELL YOUR DOCTOR if you drink alcohol; if you are going through withdrawal from alcohol or other substances; or if you have or have recently had any head injury, increased pressure in the brain, growths in the brain (eg, tumors), or infection of the brain or nervous system. USE OF THIS MEDICINE IS NOT RECOMMENDED if you are having an asthma attack oryou have high blood carbon dioxide levels (hypercarbia), a certain severe bowel problem (eg, paralytic ileus), severe asthma, or severe slow or difficult breathing. Contact your doctor or pharmacist if you have any questions or concerns about taking this medicine.

How to Use This Medicine:

Follow the directions for using this medicine provided by your doctor. Take this medicine by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation. IF YOU HAVE BEEN taking this medicine regularly or for longer than a few weeks, do not suddenly stop taking it without checking with your doctor. Your doctor may need to gradually lower your dose. STORE THIS MEDICINE at room temperature between 68 and 77 degrees F (20 and 25 degrees C) in a tightly-closed container, away from heat, moisture, and light. 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.


DO NOT TAKE THIS MEDICINE if you have had an allergic reaction to it or if you are allergic to any ingredient in this product. CHECK WITH YOUR DOCTOR before you take this medicine if you have had an allergic reaction to any codeine- or morphine-related medicine (eg, hydrocodone, dihydrocodeine, hydromorphone). WHEN USING FOR AN EXTENDED PERIOD, this medicine may not work as well and may require different dosing. Talk with your doctor if this medicine stops working well. DO NOT EXCEED THE RECOMMENDED DOSE, take this medicine more often, or for longer than prescribed without checking with your doctor. Exceeding the recommended dose or taking this medicine for longer than prescribed may be habit-forming. BEFORE YOU HAVE ANY MEDICAL OR DENTAL TREATMENTS, EMERGENCY CARE, OR SURGERY, tell the doctor or dentist that you are using this medicine. THIS MEDICINE MAY AFFECT CERTAIN LAB TEST RESULTS. Make sure laboratory personnel and your doctors know you use this medicine. This medicine may cause drowsiness, dizziness, light-headedness, or blurred vision. DO NOT DRIVE, OPERATE MACHINERY, OR DO ANYTHING ELSE THAT COULD BE DANGEROUS until you know how you react to this medicine. Using this medicine alone, along with other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks. To minimize dizziness or lightheadedness, get up slowly when rising from a seated or lying position. AVOID ALCOHOLIC BEVERAGES while taking this medicine. Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers, narcotic pain medicines) while you are using this medicine; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness. THIS MEDICINE MAY CAUSE CONSTIPATION. Talk with your doctor or pharmacist about using a stool softener or laxative to prevent constipation. It is also important to 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. THIS MEDICINE CONTAINS acetaminophen. Too much acetaminophen may cause liver damage. Alcohol use combined with acetaminophen may increase this risk. Contact your doctor right away if you take more than 4000 mg of acetaminophen per day, even if you feel well. BEFORE YOU BEGIN TAKING ANY NEW MEDICINE, either prescription or over-the-counter, check with your doctor or pharmacist. This includes other pain relievers, cough-and-cold medicines, or allergy medicines. These medicines may contain additional acetaminophen. Taking too much acetaminophen can be harmful. Ask your pharmacist about the safe use of these products. CAUTION IS ADVISED WHEN USING THIS MEDICINE IN THE ELDERLY because they may be more sensitive to the effects of the medicine. FOR WOMEN: IF YOU BECOME PREGNANT, discuss with your doctor the benefitsand risks of using this medicine during pregnancy. THIS MEDICINE IS EXCRETED IN BREAST MILK. DO NOT BREAST-FEED while taking this medicine.

Possible Side Effects:

SIDE EFFECTS that may occur while taking this medicine include constipation, dizziness, drowsiness, flushing, light-headedness, nausea, vomiting. If they continue or are bothersome, check with your doctor. A VERY BAD SKIN REACTION (Stevens-Johnson syndrome / toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes. CONTACT YOUR DOCTOR IMMEDIATELY if you experience burning, numbness, or tingling; change in the amount of urine produced; confusion; fainting; fast, slow, or irregular heartbeat; fever, chills, or persistent sore throat; hallucinations; hearing loss; mental or mood changes (eg, agitation, anxiety, depression); seizures; severe or persistent constipation; severe or persistent dizziness, drowsiness, headache, or light-headedness; shortness of breath; slow or difficult breathing; stomach or back pain; symptoms of liver problems (eg, yellowing of the skin or eyes, pale stools, dark urine, persistent loss of appetite); tremors; trouble urinating; unusual bruising or bleeding; unusual tiredness or weakness; or vision changes. AN ALLERGIC REACTION to this medicine is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; or unusual hoarseness. 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 cold or clammy skin; fainting; limp muscles; loss of consciousness; persistent nausea or vomiting; pinpoint pupils; severe dizziness, drowsiness, or light-headedness; slow heartbeat; slow, shallow, or abnormal breathing; stomach pain; symptoms of liver problems (eg, yellowing of the skin or eyes, pale stools, dark urine, loss of appetite); or unusual sweating.

Additional Information:

If your symptoms do not improve or if they become worse, contact 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 USING THIS MEDICINE FOR AN EXTENDED PERIOD OF TIME, obtain refills before your supply runs out. CHECK WITH YOUR PHARMACIST about how to dispose of unused medicine.

Copyright 2014 Wolters Kluwer Health, Inc.


- This information is not intended to substitute for professional medical advice. Be sure to contact your physician, pharmacist or other health care provider for more information about this medication. By searching these web site pages, you agree to our terms and conditions of use.