This combination product contains two medications: oxycodone and acetylsalicylic acid (ASA). ASA belongs to the group of medications called analgesics (pain relievers), anti-inflammatories, and antipyretics (fever reducers). Oxycodone belongs to the group of medications called narcotic analgesics. This medication is used to relieve mild to moderately severe pain, including conditions associated with fever or inflammation.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

The dosage varies according to each individual and can be affected by the severity of the pain as well as each person's response to the medication.

The recommended adult dose is 1 full-strength tablet every 6 hours as needed.

Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

This medication may be habit-forming if taken for long periods of time. Do not stop taking this medication without talking with your doctor. If this medication is stopped suddenly, you may experience withdrawal symptoms such as anxiety, sweating, trouble sleeping, shakiness, nausea, tremors, diarrhea, or hallucinations. If you plan on stopping the medication, your doctor may want you to reduce the dose gradually to lessen the severity of withdrawal effects.

It is important to take this medication exactly as prescribed by your doctor. If your doctor has told you to take this medication on a regular basis and you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, protect it from light and moisture, and keep it out of reach of children.

Each yellow, scored tablet, contains oxycodone 5 mg and ASA 325 mg. Nonmedicinal ingredients: colloidal silicon dioxide, FD&C Yellow No. 5 Aluminum Lake, lactose, microcrystalline cellulose, sodium starch glycolate, and stearic acid.

Do not take ASA - oxycodone HCl if you:

• are allergic to oxycodone, ASA, or any ingredients of the medication
• are allergic to other opioid medications
• are under 18 years of age and have chicken pox, cold, or flu symptoms
• have mild pain that can be controlled with other medications
• have a history of stomach ulcers or duodenal ulcers
• have asthma, rhinitis (runny nose), and nasal polyps
• have pre-existing respiratory depression
• have status asthmaticus (unresponsive asthma)
• are pregnant or breast-feeding
• are experiencing slowed, shallow breathing (respiratory depression)
• have a condition that slows down passage of material through the digestive tract
• have or may have appendicitis or pancreatitis
• have acute asthma or other obstructive airway diseases (e.g., chronic bronchitis, emphysema)
• are taking an MAO inhibitor (e.g., phenelzine, tranylcypromine) or have taken one in the past 2 weeks
• have active alcoholism or are experiencing alcohol withdrawal
• have a head injury

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• constipation
• decreased appetite
• decreased interest in sexual activity
• decreased sexual ability
• dizziness
• drowsiness
• dry mouth
• headache
• itching
• lightheadedness or feeling faint
• nausea
• problems with coordinating muscle movement
• trouble sleeping
• vomiting
• weakness

Although most of these side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• increased sweating
• stomach pain (severe)
• vision changes

Stop taking the medication and seek immediate medical attention if any of the following occur:

• signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
• signs of breathing problems such as shallow, irregular breathing, or slow or troubled breathing
• symptoms of a bowel blockage (e.g., abdominal pain, severe constipation, nausea)
• symptoms of overdose of oxycodone, such as:
• abnormally slow or weak breathing
• cold, clammy skin
• confusion
• extreme drowsiness
• severe dizziness
• slow heartbeat
• symptoms of serotonin syndrome (e.g., confusion, fast heartbeat, hallucinations, restlessness, shaking, shivering, sudden jerking of muscles, sweating)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Abdominal conditions: Oxycodone may make the diagnosis of abdominal conditions more difficult, or it may worsen these conditions. If you have an abdominal condition such as inflammatory or obstructive bowel disease, acute cholecystitis, or pancreatitis, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Accidental use: When oxycodone - ASA is used by anyone other than the person for whom it was prescribed, the effects of the medication may be fatal. Children are especially at risk. Keep this medication out of sight and reach of children.

Alcohol and other medications that cause drowsiness: Do not consume alcohol while taking this medication, as this may lead to dangerous and even fatal side effects. Other medications that cause drowsiness or slow down your breathing (e.g., antidepressants, sleeping pills, anxiety medications) should be avoided if possible, as additive side effects may occur, which can be dangerous and possibly fatal.

Bleeding disorders: ASA may increase bruising and bleeding from cuts that may take longer to stop. If you have a bleeding disorder or a history of bleeding problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Breathing: Oxycodone can suppress breathing. If you are at risk for breathing difficulties such as asthma, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Dependence and withdrawal: This medication contains oxycodone. Physical dependence, psychological dependence, and abuse have occurred with the use of oxycodone. People with a history of past or current substance use problems may be at greater risk of developing abuse or addiction while taking this medication. Abuse is not a problem with people who require this medication for pain relief. If you abruptly stop taking this medication, you may experience withdrawal symptoms such as anxiety, sweating, trouble sleeping, shaking, pain, nausea, tremors, diarrhea, and hallucinations. If you have been taking this medication for a while, it should be stopped gradually as directed by your doctor.

Drowsiness/reduced alertness: This medication may cause drowsiness or dizziness, affecting your ability to drive or operate machinery. Avoid these and other potentially hazardous tasks until you have determined how this medication affects you.

Head injury: If you have a head injury or increased pressure in the head, you may have a higher risk of experiencing side effects (breathing problems) or worsening of your condition while taking this medication. Discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Kidney function: If you have kidney disease or reduced kidney function, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Liver function: If you have liver disease or reduced liver function, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Other medical conditions: If you are about to undergo surgery of the biliary tract, taking oxycodone may worsen your condition. Oxycodone will also worsen the effects of acute alcohol intoxication and delirium tremens.

As well, if you have low thyroid (hypothyroidism), Addison's disease, benign prostatic hypertrophy (enlarged prostate), urethral stricture, decreased function of the adrenal glands, or porphyria, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Seizures: This medication may cause seizures, especially when higher doses are used or when taken with other medications that may increase the risk of seizures such as:

• cyclobenzaprine
• monoamine oxidase inhibitors (MAOIs; e.g., phenelzine, tranylcypromine)
• neuroleptics (e.g., haloperidol, quetiapine, olanzapine, risperidone)
• opioids (e.g., morphine, codeine, oxycodone)
• promethazine
• selective serotonin reuptake inhibitors (SSRIs; e.g., paroxetine, fluoxetine, citalopram)
• tricyclic antidepressants (TCAs; e.g., amitriptyline, imipramine)

The risk of seizures is also higher for people with epilepsy, a history of seizures, or who are at risk of seizures (e.g., people with head trauma).

Serotonin syndrome: Although rare, severe reactions are possible when oxycodone is combined with other medications that act on serotonin, such as tricyclic antidepressants and serotonin reuptake inhibitors, which are medications used to treat depression. These combinations should be avoided if possible. Symptoms of a reaction may include muscle rigidity and spasms, difficulty moving, or changes in mental state including delirium and agitation. Coma and death are possible. 

Stomach problems: ASA may cause stomach problems such as ulcers or bleeding. If you have stomach problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Call your doctor immediately if you notice signs such as stomach or abdominal pain, black tarry stools, or vomiting blood. Using ASA at the same time as other anti-inflammatory medications increases the risk of stomach ulcers and bleeding.

Surgery: ASA can cause increased bleeding during surgery. If you are scheduled for surgery, let your doctor know that you are taking this medication. Talk to your doctor or dentist about whether you should stop taking ASA - oxycodone before any surgery, including dental surgery.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. Use of this medication can harm a developing baby as well as cause serious withdrawal symptoms in a newborn. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: This medication passes into breast milk. If you are a breast-feeding mother and are taking ASA - oxycodone, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children under 18 years of age. The use of ASA may be associated with the development of Reye's syndrome in children and teenagers who have illnesses accompanied by fever, especially influenza and chickenpox. ASA should not be given to or used by children or teenagers who have chickenpox or flu symptoms, unless a doctor is consulted.

Seniors: Seniors may be more susceptible to the harmful effects of ASA, possibly because of decreased kidney function.

There may be an interaction between ASA - oxycodone and any of the following:

• aclidinium
• alcohol
• alpha agonists (e.g., clonidine, guanfacine)
• amphetamines (e.g., dextroamphetamine, lisdexamfetamine)
• antihistamines (e.g., azelastine, cetirizine, dimenhydrinate, diphenhydramine, hydroxyzine)
• antipsychotics (e.g., cariprazine, clozapine, haloperidol, quetiapine, olanzapine, risperidone)
• apalutamide
• aprepitant
• atropine
• "azole" antifungal medications (e.g., fluconazole, itraconazole, ketoconazole)
• barbiturates (e.g., butalbital, phenobarbital)
• benzodiazepines (e.g., alprazolam, diazepam, lorazepam)
• benztropine
• beta-2 agonists (e.g., glycopyrronium, umeclidinium)
• bosentan
• brimonidine
• buprenorphine
• busulfan
• butorphanol
• calcium channel blockers (e.g., diltiazem, verapamil)
• cannabis
• carbonic anhydrase inhibitors (e.g., acetazolamide, methazolamide)
• chloral hydrate
• cobicistat
• dapsone
• desmopressin
• diphenoxylate
• disopyramide
• diuretics (water pills; e.g., furosemide, hydrochlorothiazide, triamterene)
• domperidone
• dronedarone
• efavirenz
• entacapone
• enzalutamide
• eplerenone
• esketamine
• etravirine
• flibanserin
• flunarizine
• general anesthetics (medications used to put people to sleep before surgery)
• glycopyrrolate
• grapefruit juice
• HIV protease inhibitors (e.g., atazanavir, darunavir, ritonavir)
• ipratropium
• isoniazid
• isosorbide dinitrate
• ketotifen
• lemborexant
• letermovir
• lidocaine
• linezolid
• lithium
• macrolide antibiotics (e.g., clarithromycin, erythromycin)
• magnesium sulphate
• mannitol
• methadone
• metoclopramide
• mifepristone
• minocycline
• mirtazapine
• mitotane
• modafinil
• monoamine oxidase inhibitors (e.g., tranylcypromine, phenelzine, moclobemide)
• multivitamin/mineral supplements
• muscle relaxants (e.g., baclofen, cyclobenzaprine, methocarbamol, orphenadrine)
• nabilone
• naltrexone
• nirmatrelvir
• nivolumab
• olopatadine
• other narcotic pain relievers (e.g., codeine, fentanyl, morphine, tapentadol, tramadol)
• overactive bladder medications (e.g., darifenacin, fesoterodine, oxybutynin)
• pegvisomant
• perampanel
• pramipexole
• procarbazine
• protein kinase inhibitors (e.g., ceritinib, crizotinib, imatinib, nilotinib)
• prucalopride
• rifabutin
• rifampin
• ropinirole
• rotigotine
• scopolamine
• seizure medications (e.g., clobazam, ethosuximide, levetiracetam, phenytoin, primidone, rufinamide, topiramate, valproic acid)
• selective serotonin reuptake inhibitors (SSRIs; e.g., citalopram, fluoxetine, paroxetine, sertraline, vortioxetine)
• serotonin-norepinephrine reuptake inhibitors (SNRIs; desvenlafaxine, duloxetine, venlafaxine)
• sodium phosphates
• somatostatin analogues (e.g., lanreotide, octreotide, pasireotide)
• sotorasib
• spironolactone
• St. John's wort
• tetrabenazine
• tetracaine
• thalidomide
• tiotropium
• trazodone
• tricyclic antidepressants (e.g., amitriptyline, desipramine, imipramine)
• trihexyphenidyl
• tryptophan
• vaccines
• warfarin
• zolpidem
• zopiclone

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.