Aspirin/Oxycodone Hydrochloride/Oxycodone Terephthalate Oral Tablet 325 mg/4.5 mg/0.38 mg (OXYCODONE/ASPIRIN - ORAL)

For pain.

Generic Name: Aspirin/Oxycodone Hydrochloride/Oxycodone Terephthalate

Instructions

Take the medicine with 250 mL (1 cup) of water.

Sit or stand upright for 10 minutes after taking the medicine. Do not lie down.

You may take with food or antacids to prevent stomach upset.

Store at room temperature away from heat, light, and moisture. Do not keep in the bathroom.

Please ask your doctor, nurse, or pharmacist how to discard unused medicines safely.

Drink plenty of water while on this medicine.

To reduce constipation, eat high fiber foods, drink plenty of water and exercise.

Avoid grapefruit juice while on this medicine.

Drug interactions can change how medicines work or increase risk for side effects. Tell your health care providers about all medicines taken. Include prescription and over-the-counter medicines, vitamins, and herbal medicines. Speak with your doctor or pharmacist before starting or stopping any medicine.

Tell your doctor if symptoms do not get better or if they get worse.

Talk to your doctor before taking other medicines, including aspirins and ibuprofen containing products. Speak to your doctor about which medicines are safe to use while you are on this medicine.

Do not take the medicine more than four times during 24 hours.

Cautions

IMPORTANT: Children and teenagers should not use medications containing aspirin for cold and flu symptoms or chickenpox.

This medicine has an opioid. Opioids help many people but may cause addiction, especially if used for a long time. The addiction risk is higher if you have a substance use disorder (overuse of or addiction to drugs or alcohol). Ask your doctor about the benefits and risks.

Ask your doctor or pharmacist if you should have naloxone on hand to treat opioid overdose. Teach your family or household members about the signs of an opioid overdose and how to treat it.

Tell your doctor and pharmacist if you ever had an allergic reaction to a medicine.

There is an increased risk of bleeding while on this medicine, please tell your doctor or nurse if you notice any excessive bleeding or bruising.

Do not use the medication any more than instructed.

This medicine may cause dizziness or fainting, especially after exercising or in hot weather. Be very careful when standing or sitting up quickly.

If possible, avoid using with alcohol, marijuana, or other medicines that can cause dizziness or drowsiness. These include allergy/cold products, muscle relaxers, sleep aids, and pain relievers.

Your ability to stay alert or to react quickly may be impaired by this medicine. Do not drive or operate machinery until you know how this medicine will affect you.

Avoid smoking while on this medicine. Smoking may increase your risk for stomach bleeding.

Do not breastfeed while on this medicine. This medicine can pass through breast milk to the baby.

This medicine can hurt a new baby in the womb. If you become pregnant while on this medicine, tell your doctor immediately. Your doctor may switch you to a different medicine.

This medicine should be used with caution in patients with breathing difficulties.

Call your doctor right away if you notice slow or shallow breathing.

Do not share this medicine with anyone who has not been prescribed this medicine.

Some patients have serious side effects from this medicine. Ask your pharmacist to show you the information from the Food and Drug Administration (FDA) and discuss it with you.

Side Effects

The following is a list of some common side effects from this medicine. Please speak with your doctor about what you should do if you experience these or other side effects.

  • constipation
  • dizziness or drowsiness
  • lightheadedness
  • nausea and vomiting
  • stomach upset or abdominal pain

Call your doctor or get medical help right away if you notice any of these more serious side effects:

  • agitated feeling or trouble sleeping
  • decreased appetite
  • decreased awareness or responsiveness
  • shallow, irregular breathing
  • unusual bruising or discoloration on skin
  • confusion
  • coughing up blood or vomit that looks like coffee grounds
  • fainting
  • fever
  • swelling in the neck or throat
  • hallucinations (unusual thoughts, seeing or hearing things that are not real)
  • fast, irregular, or slow heartbeat
  • signs of kidney damage (such as change in urine color or bubbly urine)
  • mood changes
  • ringing in the ears
  • seizures
  • severe stomach or bowel pain
  • dark, tarry stool
  • unusual or unexplained tiredness or weakness
  • difficulty or discomfort urinating
  • blurring or changes of vision
  • yellowing of eyes or skin

A few people may have an allergic reaction to this medicine. Symptoms can include difficulty breathing, skin rash, itching, swelling, or severe dizziness. If you notice any of these symptoms, seek medical help quickly.

Please speak with your doctor, nurse, or pharmacist if you have any questions about this medicine.

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