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

Drug Manufacturer: ENDO PHARMACEUTICALS

Common Uses: This medicine is a combination of a narcotic and acetaminophen used to relieve moderate to severe pain. Narcotic pain-relievers work by binding to opioid receptors in the brain and spinal cord, and acetaminophen decreases the formation of prostaglandins, therefore reducing pain. This medicine may also be used to treat other conditions as determined by your doctor.

Before Using This Medicine: 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 naltrexone. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking other medicines for pain, cimetidine, isoniazid, MAO inhibitors (e.g., furazolidone, linezolid, moclobemide, phenelzine, procarbazine, selegiline, isocarboxazid, tranylcypromine), anti-seizure medicines (carbamazepine, phenobarbital, phenytoin), anticholinergic medicines or antihistamines (e.g., hydroxyzine, oxybutynin, scopolamine). ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking other medicines which cause drowsiness including medicine for sleep (e.g., sedatives), tranquilizers, anti-anxiety medicines (e.g., diazepam), psychiatric medicines (e.g., phenothiazines such as chlorpromazine, or tricyclics such as amitriptyline), muscle relaxants, or antihistamines that cause drowsiness (e.g., diphenhydramine). DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions including liver or kidney disease, difficulty urinating, alcohol use, drug dependency, heart problems (e.g., slow/irregular heartbeat, very low blood pressure), abdominal/stomach problems (e.g., gallbladder problems), lung disease (e.g., asthma, chronic obstructive pulmonary disease), seizure disorders, serious head injury or brain disease, spinal problems, low thyroid disease, adrenal gland problems, psychiatric problems, any allergies, pregnancy, or breast-feeding. USE OF THIS MEDICINE IS NOT RECOMMENDED if you have a history of severe breathing problems, or severe diarrhea. 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. THIS MEDICINE MAY BE TAKEN WITH FOOD if it upsets your stomach, although doing so may decrease its effectiveness. Consult your doctor or pharmacist about alternatives for decreasing nausea (such as antihistamines, or lying down for 1-2 hours with minimal head movement). STORE THIS MEDICINE at room temperature in a tightly-closed container, away from heat, and light. 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.

Cautions: DO NOT TAKE THIS MEDICINE IF YOU HAVE HAD A SEVERE ALLERGIC REACTION to codeine, hydrocodone, dihydrocodeine, or oxycodone (such as Tylox, Tylenol with Codeine, Vicodin). A severe allergic reaction includes a severe rash, hives, breathing difficulties, or dizziness. If you have a question about whether you are allergic to this medicine or if a certain medicine contains codeine, hydrocodone, dihydrocodeine, or oxycodone, contact your doctor or pharmacist. Monitor your pain as directed by your doctor. If pain is left untreated and becomes intense, this medicine may not work as well to relieve it. 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. If using this medicine for an extended period of time, DO NOT SUDDENLY STOP taking this medicine without your doctor's approval. 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. THIS MEDICINE MAY CAUSE drowsiness or dizziness. Using this medicine alone, with other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks. AVOID ALCOHOLIC BEVERAGES while taking this medicine. To minimize dizziness or lightheadedness, get up slowly when rising from a seated or lying position. To prevent constipation, maintain a diet adequate in fiber, drink plenty of water, and exercise. If you become constipated while using this medicine talk with your doctor or pharmacist. This medicine contains acetaminophen. Adults should not take more than a total of 4 grams of acetaminophen per day (3 grams per day if you have liver disease). Consult your doctor or pharmacist for more information. Acetaminophen may cause liver damage. If you drink alcohol on a daily basis, do not take this medicine without first discussing it with your doctor. Alcohol use combined with acetaminophen may increase your risk for liver damage (symptoms include yellowing eyes or skin, stomach pain, dark urine). 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, especially the possible decreased breathing and drowsiness effects. FOR WOMEN: IF YOU PLAN ON BECOMING PREGNANT, discuss with your doctor the benefits and risks of using this medicine during pregnancy. THIS MEDICINE IS EXCRETED IN BREAST MILK. IF YOU ARE OR WILL BE BREAST-FEEDING while you are using this medicine, check with your doctor to discuss the risks to your baby.

Possible Side Effects: SIDE EFFECTS, that may go away during treatment, include nausea, vomiting, constipation, lightheadedness, dizziness, drowsiness, flushing, vision changes, or mental/mood changes. If they continue or are bothersome, check with your doctor. CONTACT YOUR DOCTOR IMMEDIATELY if you experience slow/irregular breathing, slow/irregular heartbeat, or a change in the amount of urine. 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, severe dizziness, or trouble breathing. If you notice other effects not listed above, contact your doctor, nurse, or pharmacist.

Overdose: If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include extreme drowsiness, weakness, fatigue, or loss of consciousness; slow, shallow or abnormal breathing; persistent nausea/vomiting, stomach pain; slow heartbeat; cold/clammy skin, unusual sweating; and yellowing of the eyes or skin.

Additional Information: 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. KEEP THIS MEDICINE out of the reach of children and pets.