When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction (including asthma) to ibuprofen, oxycodone, aspirin, or similar pain medicines.

How to Use This Medicine:
Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Drink plenty of liquids to help avoid constipation.
• Missed dose:Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines and food can affect how oxycodone and ibuprofen work. Tell your doctor if you are also using any of the following:
  
  • Another NSAID, including aspirin
  • Antidepressant
  • Diuretic, including furosemide or a thiazide
  • ACE inhibitor
  • Corticosteroid, including hydrocortisone, methylprednisolone, prednisone, prednisolone, dexamethasone)
  • Blood thinner, including warfarin
  • Lithium or methotrexate
  • Monoamine oxidase inhibitor (MAOI)
• Tell your doctor if you use anything else that makes you sleepy. Some examples are allergy medicine, narcotic pain medicine, and alcohol.
• Do not drink alcohol while you are using this medicine. Do not take any medicine that contains alcohol.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding. Do not use this medicine during the later part of your pregnancy.
• Tell your doctor if have kidney disease, liver disease, bleeding problems, high blood pressure or circulation problem, asthma or other lung disease, or heart failure or other heart problems. Tell your doctor if you have lupus, Addison disease or other thyroid problems, trouble urinating, prostate disorder, or a history of head injury, brain tumor, seizure, or pancreatitis or digestive problems.
• This medicine might cause the following problems:
  
  • Anemia or bleeding problems
  • Bleeding and ulcers in your stomach or intestines
  • High blood pressure
  • Higher risk of heart attack or stroke
  • Kidney damage
  • Liver damage
• This medicine may make you dizzy or drowsy. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
• Too much of this medicine can cause death. Symptoms of an overdose include extreme slow heartbeat, seizure, and cold, clammy skin.
• This medicine can be habit-forming. Do not use more than your prescribed dose. Call your doctor if you think your medicine is not working.
• This medicine may cause constipation, especially with long-term use. Ask your doctor if you should use a laxative to prevent and treat constipation.
• Keep all medicine out of the reach of children. Never share your medicine with anyone. An overdose in a child could cause death.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, or red skin rash
• Change in how much or how often you urinate
• Chest pain that may spread, trouble breathing, nausea, unusual sweating, fainting
• Chest pain, trouble breathing, or coughing up blood
• Dark urine or pale stools, nausea, vomiting, loss of appetite, yellow skin or eyes
• Extreme weakness, shallow breathing, slow heartbeat, sweating, cold or clammy skin
• Fever, neck pain or stiff neck
• Lightheadedness, dizziness, fainting
• Numbness or weakness in one side of your body, sudden or severe headache, problems with vision, speech, or walking
• Rapid weight gain, swelling in your hands, ankles, or feet
• Severe stomach pain, vomiting blood, bloody or black, tarry stools
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Constipation, diarrhea, heartburn, nausea
• Sleepiness

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088