Aspirin (AS-pir-in), Oxycodone Hydrochloride (ox-i-KOE-done hye-droe-KLOR-ide)

Treats moderate to severe pain. This medicine contains an opioid pain reliever and an NSAID.

Brand Name(s):

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• An overdose can be dangerous. Follow directions carefully so you do not get too much medicine at one time. Your doctor may also give naloxone to treat an overdose. Naloxone is a medicine that temporarily reverses the effects of an overdose. If you have been prescribed naloxone, make sure household members know how to use this on you in the event of an overdose or suspected overdose. Emergency medical attention is still needed after naloxone is used because the reversal effects are only temporary.
• Drink plenty of liquids to help avoid constipation.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• 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. Store the medicine in a safe and secure place. Drop off any unused opioid medicine at a drug take-back location right away. If you do not have a drug take-back location near you, flush any unused opioid medicine down the toilet. Check your local drug store and clinics for take-back locations. You can also check the DEA web site for locations. Here is the link to the FDA safe disposal of medicines website: www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/ensuringsafeuseofmedicine/safedisposalofmedicines/ucm186187.htm

Drugs and Foods to Avoid:

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

• Do not use this medicine if you are using or have used an MAO inhibitor within the past 14 days.
• Some medicines can affect how this medicine works. Tell your doctor if you are also using any of the following:
  • Acetazolamide, cyclobenzaprine, metaxalone, methotrexate, probenecid, ritonavir, sulfinpyrazone, tramadol
  • Blood pressure medicine
  • Blood thinner (including heparin or warfarin)
  • Diuretic (water pill)
  • Insulin or other diabetes medicine
  • Medicine to treat depression, anxiety, or mental health problems (including mirtazapine, trazodone, SNRIs, SSRIs, TCAs)
  • Medicine to treat infection (including erythromycin, ketoconazole, rifampin)
  • Medicine to treat seizures (including carbamazepine, phenytoin, valproic acid)
  • NSAID pain or arthritis medicine (including celecoxib, diclofenac, ibuprofen, ketorolac, naproxen)
  • Phenothiazine medicine
  • Triptan medicine for migraine headaches
• Do not drink alcohol while you are using this medicine. Do not take any medicine that contains alcohol.
• Tell your doctor if you use anything else that makes you sleepy. Some examples are allergy medicine, narcotic pain medicine, and alcohol. Tell your doctor if you are using buprenorphine, butorphanol, nalbuphine, naltrexone, pentazocine, or a muscle relaxer.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant. Do not use this medicine during the later part of a pregnancy, unless your doctor tells you to.
• Do not breastfeed while you are using this medicine, unless your doctor tells you to.
• Tell your doctor if you have kidney disease, liver disease, anemia, blood clotting problems, lung disease or breathing problems (including sleep apnea), circulation problems, stomach ulcers, Addison disease, enlarge prostate, trouble urinating, thyroid problems, or a history of head injury, seizures, pancreatitis, alcohol abuse or drug use disorder.
• This medicine might cause the following problems:
  • High risk of overdose, which can lead to death
  • Respiratory depression (serious breathing problem that can be life-threatening)
  • Sleep-related breathing problems (including sleep apnea, sleep-related hypoxemia)
  • Worsening of pain
  • Adrenal gland problems
  • Low blood pressure
  • Seizures
  • Kidney problems
  • Liver problems
  • Serotonin syndrome, when used with certain medicines
  • Stomach or bowel problems (including bleeding, ulcers, or perforation)
  • Serious skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS)
• 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.
• Do not stop using this medicine suddenly. Your doctor will need to slowly decrease your dose before you stop it completely.
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.
• 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.
• This medicine could cause infertility. Talk with your doctor before using this medicine if you plan to have children.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

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
• Anxiety, restlessness, fast heartbeat, fever, sweating, muscle spasms, twitching, diarrhea, seeing or hearing things that are not there
• Blistering, peeling, red skin rash
• Bloody, black, or tarry stools, coughing up blood, vomiting of blood or material that looks like coffee grounds
• Blue lips, fingernails, or skin, change or loss of consciousness, shallow breathing, slow or uneven heartbeat, sweating, cold or clammy skin, pinpoint pupils
• Change in how much or how often you urinate
• Changes in skin color, dark freckles, cold feeling, tiredness, weight loss
• Confusion, trouble breathing, numbness or tingling in your hands, feet, or lips
• Dark urine or pale stools, nausea, vomiting, stomach pain, loss of appetite, yellow skin or eyes
• Lightheadedness, dizziness, fainting
• Unusual bleeding, bruising, or weakness
• Worsening of pain, increased sensitivity to pain

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

• Constipation, stomach upset
• 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