OXYCODONE; ASPIRIN (ox i KOE done; AS pir in) treats severe pain. It is prescribed when other pain medications have not worked or cannot be tolerated. It works by blocking pain signals in the brain. It also decreases inflammation. It is a combination of an opioid and an NSAID.

How should I use this medication?

Take this medication by mouth with water. Take it as directed on the prescription label at the same time every day. You can take this medication with or without food. If it upsets your stomach, take it with food. Keep taking it unless your care team tells you to stop. A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time. Talk to your care team about the use of this medication in children. It is not approved for use in children. People 65 years and older may have a stronger reaction and need a smaller dose.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once. NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

Where should I keep my medication?

Keep this medication out of reach of children and pets. Store it out of sight in a safe place. Do not share it with others. Misuse of this medication is dangerous and against the law. Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Protect from light and moisture. Keep the container tightly closed. Get rid of any unused medication after the expiration date. This medication may cause harm and death if it is taken by other adults, children, or pets. It is important to get rid of the medication as soon as you no longer need it or it is expired. To get rid of this medication: -Take the medication to a take-back program. Check with your pharmacy or law enforcement to find a location. -Follow the steps given to you by your pharmacy. You may be given a pre-paid mail-back envelope or disposal product to safely get rid of your medication. -If other options are not available, flush the medication down the toilet.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible: -Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat -Bleeding—bloody or black, tar-like stools, vomiting blood or brown material that looks like coffee grounds, red or dark brown urine, small red or purple spots on skin, unusual bruising or bleeding -CNS depression—slow or shallow breathing, shortness of breath, feeling faint, dizziness, confusion, trouble staying awake -Hearing loss, ringing in ears -Kidney injury—decrease in the amount of urine, swelling of the ankles, hands, or feet -Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue -Low adrenal gland function—nausea, vomiting, loss of appetite, unusual weakness or fatigue, dizziness -Low blood pressure—dizziness, feeling faint or lightheaded, blurry vision -Rash, fever, and swollen lymph nodes -Redness, blistering, peeling, or loosening of the skin, including inside the mouth -Round red or dark patches on the skin that may itch, burn, and blister Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome): -Constipation -Dizziness -Drowsiness -Dry mouth -Headache -Nausea -Vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions: -Bleeding disorder -Brain tumor -Constipation -Frequently drink alcohol -Head injury -Heart disease -Low adrenal gland function -Lung or breathing disease, such as asthma -Seizures -Stomach or intestine problems -Substance use disorder -Taken an MAOI, such as Marplan, Nardil, or Parnate in the last 14 days -An unusual or allergic reaction to aspirin, oxycodone, other medications, foods, dyes, or preservative -Pregnant or trying to get pregnant -Breastfeeding

What may interact with this medication?

Do not take this medication with any of the following: -Abrocitinib -Cidofovir -Defibrotide -Ketorolac -Olanzapine; samidorphan -Probenecid -Safinamide This medication may also interact with the following: -Alcohol -Antihistamines for allergy, cough, and cold -Aspirin and aspirin-like medications -Atropine -Benzodiazepines, such as alprazolam, diazepam, lorazepam -Certain medications for bladder problems, such as oxybutynin or tolterodine -Certain medications for depression, anxiety, or other mental health conditions -Certain medication for migraines, such as sumatriptan -Certain medications for Parkinson disease, such as benztropine or trihexyphenidyl -Certain medications for seizures, such as phenobarbital or primidone -Certain medications for stomach problems, such as dicyclomine or hyoscyamine -Certain medications for travel sickness, such as scopolamine -Certain medications that prevent or treat blood clots -Diuretics -Ipratropium -Linezolid -Medications that cause drowsiness before a procedure, such as propofol -Medications that help you fall asleep -Medications that relax muscles -Methotrexate -Methylene blue -NSAIDs, medications for pain and inflammation, such as ibuprofen or naproxen -Other opioids for pain or cough -Pemetrexed -Phenothiazines, such as chlorpromazine, prochlorperazine, thioridazine -Steroid medications, such as prednisone or cortisone -St. John's wort -Stimulant medications for ADHD, weight loss, or staying awake -Tryptophan Other medications may affect the way this medication works. Talk with your care team about all of the medications you take. They may suggest changes to your treatment plan to lower the risk of side effects and to make sure your medications work as intended.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Tell your care team if your pain does not go away, if it gets worse, or if you have new or a different type of pain. You may develop tolerance to this medication. Tolerance means that you will need a higher dose of the medication for pain relief. Tolerance is normal and is expected if you take this medication for a long time. This medication is a CNS depressant. This is a type of medication or substance that slows down your brain and nervous system. Taking it with other CNS depressants can make you too sleepy. This can make it hard to breathe and stay awake. In some cases, it can cause coma and death. CNS depressants include opioids, benzodiazepines, muscle relaxants, medications for sleep, alcohol, and street drugs. Talk to your care team about all the medications, vitamins, and supplements you take. They can tell you what is safe to take together. Call emergency services right away if you have slow or shallow breathing, feel dizzy or confused, or have trouble staying awake. If you have taken this medication for a long time or take a high dose, your body may rely on it. Stopping it suddenly may cause a severe reaction. When it is time to stop, the dose will be slowly lowered over time to reduce the risk of side effects. Naloxone is an emergency medication used for an opioid overdose. An overdose can happen if you take too much of an opioid. It can also happen if an opioid is taken with some other medications or substances such as alcohol. Know the symptoms of an overdose, such as trouble breathing, unusually tired or sleepy, or not being able to respond or wake up. Make sure to tell caregivers and close contacts where your naloxone is stored. Make sure they know how to use it. After naloxone is given, the person giving it must call emergency services. Naloxone is a temporary treatment. Repeat doses may be needed. This medication may affect your coordination, reaction time, or judgment. Do not drive or operate machinery until you know how this medication affects you. Sit up or stand slowly to reduce the risk of dizzy or fainting spells. Drinking alcohol with this medication can increase the risk of these side effects. Do not take aspirin or other NSAIDs, such as ibuprofen or naproxen, while you are taking this medication. Side effects, such as upset stomach, nausea, and ulcers, may be more likely to occur. Many over-the-counter medications contain aspirin, ibuprofen, or naproxen. It is important to read labels carefully. Talk to your care team about all the medications you take. They can tell you what is safe to take together. This medication can cause serious bleeding, ulcers, or tears in the stomach. These problems can occur at any time and with no warning signs. They are more common with long-term use. Talk to your care team right away if you have stomach pain, bloody or black, tar-like stools, or vomit blood that is red or looks like coffee grounds. This medication may cause serious skin reactions. They can happen weeks to months after starting the medication. Talk to your care team right away if you have fevers or flu-like symptoms with a rash. The rash may be red or purple and then turn into blisters or peeling of the skin. Or you might notice a red rash with swelling of the face, lips, or lymph nodes in your neck or under your arms. This medication will cause constipation. If you do not have a bowel movement for 3 days, call your care team. Your mouth may get dry. Chewing sugarless gum or sucking hard candy and drinking plenty of water may help. Contact your care team if the problem does not go away or is severe. Talk to your care team if you may be pregnant. Taking this medication after 20 weeks of pregnancy may cause serious fetal side effects. Use of this medication after 30 weeks of pregnancy is not recommended. Talk to your care team before breastfeeding. Changes to your treatment plan may be needed. If you breastfeed while taking this medication, seek medical care right away if you notice the child has slow or noisy breathing, is unusually sleepy or not able to wake up, or is limp. Long-term use of this medication may cause infertility. Talk to your care team if you are concerned about your fertility.

What are the most serious risks of this medication?

Tell your healthcare provider if you are pregnant or trying to get pregnant. If you take this medicine while pregnant, your newborn baby may have withdrawal symptoms that can be life-threatening. Your baby will need special care after delivery. This medicine is a CNS depressant. It can cause deadly breathing problems. The risk is greatest when you first start taking it, when your dose is changed, if you take too much, or if you take another CNS depressant medicine. CNS depressants include: opioid pain medicines; opioid cough medicines; benzodiazepines; certain other sleep medicines and tranquilizers; muscle relaxants; antipsychotics; and alcohol in drinks or medicines. Tell your healthcare provider all the prescriptions, over-the-counter medicines, and supplements you take. Call your healthcare provider or get emergency medical help right away if you have: trouble breathing; have drowsiness with slowed breathing; have slow, shallow breathing; feel faint, very dizzy, confused, or have unusual symptoms. Using this medicine, even when using it as directed, can lead to misuse, abuse, or addiction. Misuse, abuse, or addiction can result in overdose and death. This medicine has a risk of overdose. Starting or stopping certain medicines may increase this risk. Talk to your healthcare provider about all medicines you take before making any changes. Get emergency help if you take too much of this medicine. Never give it to anyone else. They can have a deadly overdose from just 1 dose of this medicine. Store it in a safe place and away from children.