A333 (Acetaminophen and oxycodone hydrochloride 325 mg / 10 mg)


Oxycodone is a moderately potent opioid (narcotic) analgesic generally indicated for relief of moderate to severe pain. It works in the brain to change how your body feels and responds to pain. Acetaminophen is a less potent pain reliever and fever reducer that increases the effects of oxycodone and works by blocking the effects of a specific enzyme, known as cyclo-oxygenase (COX). This combination medicine helps relieve moderate to severe pain and is under the drug class narcotic analgesic combinations.


  • A combination of this medication is more effective than one drug alone.
  • Used for the treatment of moderate-to-moderately severe pain unresponsive to other treatment options.
  • This medication is available in tablet and oral solution forms, extended-release forms, as well as some cost-saving generic versions.


  • Overdose of acetaminophen component can cause liver injury or death.
  • Oxycodone content of this drug can cause stomach upset, nausea, vomiting, and dizziness.
  • Acetaminophen has no anti-inflammatory action unlike NSAID pain relievers.
  • This medicine is habit-forming and can slow or stop breathing.
  • Misuse can cause addiction, overdose, or death.
  • The baby could become dependent on the drug and can cause withdrawal symptoms to the newborn when taken during pregnancy.
  • Skin redness or rash can occur, which causes blistering and peeling that could be fatal.
  • Dangerous side effects may occur if taken with alcohol.
  • Acetaminophen and oxycodone can pass through breast milk and may harm the nursing baby.
  • This medicine is more likely to cause breathing problems in older adults and people who are severely ill, malnourished, or otherwise debilitated.
  • Alcohol combined with acetaminophen/oxycodone can lead to serious or fatal side effects.
  • This medicine can impair your thinking and reactions which may affect driving and other activities that require you to be awake and alert.
  • Fatal overdose may result from taking other products together which can cause too much acetaminophen.

Side Effects

Common side effects:

  • headache, drowsiness, tiredness
  • nausea, vomiting, stomach pain, constipation
  • blurred vision
  • dry mouth.

Some of these side effects may decrease with use overtime. Report to your doctor any worsening symptoms. Seek emergency help with symptoms indicated below or for any other effects of this medication not listed.

Serious side effects:

  • shallow breathing, slow heartbeat
  • a light-headed feeling, like you might pass out
  • confusion, unusual thoughts or behavior
  • seizure (convulsions)
  • problems with urination
  • infertility, missed menstrual periods
  • impotence, sexual problems, loss of interest in sex
  • liver problems–nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes)
  • low cortisol levels–nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness

Allergic Reactions:

  • hives
  • difficulty breathing
  • swelling of your face, lips, tongue, or throat

Overdose Symptoms:

  • slow breathing and heart rate,
  • severe drowsiness
  • muscle weakness
  • cold and clammy skin
  • pinpoint pupils
  • fainting


  • Seek emergency help with serious side effects or worsening symptoms.
  • Inform the doctor if the medicine doesn’t seem to work or if you feel you have become addicted to this drug.
  • Do not exceed the prescribed dosage. Follow doctor’s advice and prescription label.
  • Tell the doctor your medical history and medications taken (over-the-counter, herbal products, vitamins, etc.)
  • To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.
  • Eat high fiber diet and increase water intake while under treatment.
  • Inform your doctor if you intend to take other medicines or if you need to undergo surgery.
  • Swallow extended-release acetaminophen/oxycodone whole.
  • Do not cut, crush, chew or attempt to dissolve extended-release pill because rapid release and absorption of a potentially fatal dose of oxycodone may occur.
  • Properly measure liquid form of this medicine.
  • Keep in a safe and secure place away from others including pets and children. Properly discard medicines no longer in use.
  • Store at room temperature away from moisture and heat.


This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment.


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