Uses of Oxycodone and Acetaminophen Extended-Release Tablets:

• It is used to ease pain.

What do I need to tell my doctor BEFORE I take Oxycodone and Acetaminophen Extended-Release Tablets?

• If you have an allergy to oxycodone, acetaminophen, or any other part of this medicine (oxycodone and acetaminophen extended-release tablets).
• If you are allergic to this medicine (oxycodone and acetaminophen extended-release tablets); any part of this medicine (oxycodone and acetaminophen extended-release tablets); or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have any of these health problems: Lung or breathing problems like asthma, trouble breathing, or sleep apnea; high levels of carbon dioxide in the blood; or stomach or bowel block or narrowing.
• If you have taken certain drugs for depression or Parkinson's disease in the last 14 days. This includes isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline. Very high blood pressure may happen.
• If you are taking any of these drugs: Linezolid or methylene blue.
• If you are taking any of these drugs: Buprenorphine, butorphanol, nalbuphine, or pentazocine.
• If you are breast-feeding or plan to breast-feed.

This is not a list of all drugs or health problems that interact with this medicine (oxycodone and acetaminophen extended-release tablets).

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine (oxycodone and acetaminophen extended-release tablets) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Oxycodone and Acetaminophen Extended-Release Tablets?

• Tell all of your health care providers that you take this medicine (oxycodone and acetaminophen extended-release tablets). This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how this medicine (oxycodone and acetaminophen extended-release tablets) affects you.
• To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
• Long-term or regular use of opioid drugs like this medicine (oxycodone and acetaminophen extended-release tablets) may lead to dependence. Lowering the dose or stopping this medicine (oxycodone and acetaminophen extended-release tablets) all of a sudden may cause a greater risk of withdrawal or other severe problems. Talk to your doctor before you lower the dose or stop this medicine (oxycodone and acetaminophen extended-release tablets). You will need to follow your doctor’s instructions. Tell your doctor if you have more pain, mood changes, thoughts of suicide, or any other bad effects.
• Avoid taking other products that have acetaminophen in them. Check labels closely. Too much acetaminophen may cause liver problems.
• Follow the directions exactly. Do not take more acetaminophen in a day than directed. If you do not know how much acetaminophen you can take in a day, ask your doctor or pharmacist. Some people may take up to 4,000 mg (milligrams) in a day if told to do so by the doctor. Some people (like people with liver problems and children) should take less acetaminophen. Call your doctor right away if you have taken too much acetaminophen in a day, even if you feel well.
• Allergic reactions have happened with this medicine (oxycodone and acetaminophen extended-release tablets). Rarely, some reactions can be very bad or life-threatening. Talk with the doctor.
• A severe and sometimes deadly problem called serotonin syndrome may happen if you take this medicine (oxycodone and acetaminophen extended-release tablets) with certain other drugs. Call your doctor right away if you have agitation; change in balance; confusion; hallucinations; fever; fast or abnormal heartbeat; flushing; muscle twitching or stiffness; seizures; shivering or shaking; sweating a lot; severe diarrhea, upset stomach, or throwing up; or severe headache.
• Long-term use of an opioid drug may lead to lower sex hormone levels. Call your doctor if you have a lowered interest in sex, fertility problems, no menstrual period (women), or change in sex ability (men).
• This medicine may raise the chance of seizures in some people, including people who have had seizures in the past. Talk to your doctor to see if you have a greater chance of seizures while taking this medicine (oxycodone and acetaminophen extended-release tablets).
• If you are 65 or older, use this medicine (oxycodone and acetaminophen extended-release tablets) with care. You could have more side effects.
• This medicine may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking this medicine (oxycodone and acetaminophen extended-release tablets), call your doctor right away.

How is this medicine (Oxycodone and Acetaminophen Extended-Release Tablets) best taken?

Use this medicine (oxycodone and acetaminophen extended-release tablets) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take by mouth only.
• Take with or without food. Take with food if it causes an upset stomach.
• Swallow whole. Do not chew, break, or crush.
• Take 1 tablet at a time if your dose is more than 1 tablet. Do not lick or wet the tablet before putting it in your mouth. Swallow the tablet with lots of water right after putting it in your mouth.
• If you have trouble swallowing, talk with your doctor.
• Do not inject or snort this medicine (oxycodone and acetaminophen extended-release tablets). Doing any of these things can cause very bad side effects like trouble breathing and death from overdose.
• Do not take more than what your doctor told you to take. Taking more than you are told may raise your chance of very bad side effects.
• Do not take this medicine (oxycodone and acetaminophen extended-release tablets) with other strong pain drugs or if you are using a pain patch without talking to your doctor first.
• If you have been taking this medicine (oxycodone and acetaminophen extended-release tablets) for a long time or at high doses, it may not work as well and you may need higher doses to get the same effect. This is known as tolerance. Call your doctor if this medicine (oxycodone and acetaminophen extended-release tablets) stops working well. Do not take more than ordered.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take this medicine (oxycodone and acetaminophen extended-release tablets).

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.
• If you are not sure what to do if you miss a dose, call your doctor.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• Very bad dizziness or passing out.
• Feeling very sleepy.
• Trouble breathing, slow breathing, or shallow breathing.
• Feeling confused.
• Hallucinations (seeing or hearing things that are not there).
• Mood changes.
• Very bad constipation.
• Very bad belly pain.
• Feeling very tired or weak.
• A burning, numbness, or tingling feeling that is not normal.
• Not able to pass urine or change in how much urine is passed.
• Fast or slow heartbeat.
• A heartbeat that does not feel normal.
• Fever or chills.
• Sore throat.
• Hearing loss.
• Seizures.
• Very bad headache.
• Shakiness.
• Any unexplained bruising or bleeding.
• Change in eyesight.
• Chest pain.
• Memory problems or loss.
• Trouble walking.
• Trouble speaking.
• Swelling in the arms or legs.
• 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.
• Taking an opioid drug like this medicine (oxycodone and acetaminophen extended-release tablets) may lead to a rare but very bad adrenal gland problem. Call your doctor right away if you have very bad dizziness or passing out, very bad upset stomach or throwing up, or if you feel less hungry, very tired, or very weak.

What are some other side effects of Oxycodone and Acetaminophen Extended-Release Tablets?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Constipation.
• Belly pain.
• Dizziness.
• Feeling sleepy.
• Headache.
• Upset stomach or throwing up.
• Feeling tired or weak.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Oxycodone and Acetaminophen Extended-Release Tablets?

• Store at room temperature.
• Protect from light.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time this medicine (oxycodone and acetaminophen extended-release tablets) is refilled. If you have any questions about this medicine (oxycodone and acetaminophen extended-release tablets), please talk with the doctor, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.