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Oxycodone and Aspirin Oxycodone Hydrochloride and Aspirin

Get an overview of OXYCODONE AND ASPIRIN (oxycodone hydrochloride and aspirin tablet), including its generic name, formulation (i.e. pill, oral solution, injection, inhaled medicine) and why it’s used. The medication in Oxycodone and Aspirin can be sold under different names.

Refer to the “Also Known As” section to reference different products that include the same medication as Oxycodone and Aspirin.

Drug Basics

Brand Name: Oxycodone and Aspirin

Generic Name: OXYCODONE HYDROCHLORIDE AND ASPIRIN

Drug Type: HUMAN PRESCRIPTION DRUG

Route: ORAL

Dosage Form: TABLET

Data Current As Of: 2019-09-09

CII

Rx only

indications & usage

Oxycodone and aspirin tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

limitations of use

Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses (see WARNINGS), reserve oxycodone and aspirin tablets for use in patients for whom alternative treatment options (e.g., non- opioid analgesics)

  • Have not been tolerated, or are not expected to be tolerated,
  • Have not provided adequate analgesia, or are not expected to provide adequate analgesia

contraindications

Oxycodone and aspirin tablets are contraindicated in patients with:

  • Significant respiratory depression (see WARNINGS)
  • Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment (see WARNINGS)
  • Known or suspected gastrointestinal obstruction, including paralytic ileus (see WARNINGS)
  • Hypersensitivity to oxycodone or aspirin, (e.g. angioedema) (see WARNINGS)
  • Patients with hemophilia.
  • Aspirin should not be used in children or teenagers for viral infections, with or without fever, because of the risk of Reye syndrome (see WARNINGS)

Manufactured by:

Mayne Pharma
Greenville, NC 27834

61191
August 2019

Medication Guide
Oxycodone and Aspirin Tablets (ox-ee-CO-dohn and As-pir-in), for oral use, CII
    This Medication Guide has been approved by the U.S. Food and Drug Administration. Issued: April 2019
Oxycodone and aspirin tablets are:
  • A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage pain severe enough to require an opioid pain medicine when other pain treatments such as non-opioid pain medicines do not treat your pain well enough or you cannot tolerate them.
  • An opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed you are at risk for opioid addiction, abuse, and misuse that can lead to death.
Important information about oxycodone and aspirin tablets:
  • Get emergency help right away if you take too much oxycodone and aspirin tablets (overdose). When you first start taking oxycodone and aspirin tablets, when your dose is changed, or if you take too much (overdose), serious or life- threatening breathing problems that can lead to death may occur.
  • Taking oxycodone and aspirin tablets with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.
  • Never give anyone else your oxycodone and aspirin tablets. They could die from taking it. Selling or giving away oxycodone and aspirin tablets is against the law.
  • Store oxycodone and aspirin tablets securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home.
Do not take oxycodone and aspirin tablets if you have:
  • severe asthma, trouble breathing, or other lung problems.
  • a bowel blockage or have narrowing of the stomach or intestines.
Before taking oxycodone and aspirin tablets, tell your healthcare provider if you have a history of:
  • head injury, seizures
  • problems urinating
  • liver, kidney, thyroid problems
  • pancreas or gallbladder problems
  • abuse of street or prescription drugs, alcohol addiction, or mental health problems.
Tell your healthcare provider if you are:
  • pregnant or planning to become pregnant. Prolonged use of oxycodone and aspirin tablets during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.
  • breastfeeding. oxycodone and aspirin tablets passes into breast milk and may harm your baby.
  • taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking oxycodone and aspirin tablets with certain other medicines can cause serious side effects that could lead to death.
When taking oxycodone and aspirin tablets:
  • Do not change your dose. Take oxycodone and aspirin tablets exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed. Take your prescribed dose at the same time every day. Do not take more than your prescribed dose. If you miss a dose, take your next dose at your usual time.
  • Call your healthcare provider if the dose you are taking does not control your pain.
  • If you have been taking oxycodone and aspirin tablets regularly, do not stop taking oxycodone and aspirin tablets without talking to your healthcare provider.
  • Dispose of expired, unwanted, or unused oxycodone and aspirin tablets by promptly flushing down the toilet, if a drug take-back option is not readily available. Visit www.fda.gov/drugdisposal for additional information on disposal of unused medicines.
While taking oxycodone and aspirin tablets DO NOT:
  • Drive or operate heavy machinery, until you know how oxycodone and aspirin tablets affects you. oxycodone and aspirin tablets can make you sleepy, dizzy, or lightheaded.
  • Drink alcohol or use prescription or over-the-counter medicines that contain alcohol. Using products containing alcohol during treatment with oxycodone and aspirin tablets may cause you to overdose and die.
The possible side effects of oxycodone and aspirin tablets:
  • constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, abdominal pain. Call your healthcare provider if you have any of these symptoms and they are severe.
Get emergency medical help if you have:
  • trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue or throat, extreme drowsiness, light-headedness when changing positions, feeling faint, agitation, high body temperature, trouble walking, stiff muscles, or mental changes such as confusion.
These are not all the possible side effects of oxycodone and aspirin tablets. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. For more information go to dailymed.nlm.nih.gov
Manufactured by: Mayne Pharma, Greenville, NC 27834

This drug label information is as submitted to the Food and Drug Administration (FDA) and is intended for informational purposes only. If you think you may have a medical emergency, immediately call your doctor or dial 911. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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