Roxicet contains a combination of acetaminophen and oxycodone. Oxycodone is an opioid pain medication. It works in the brain to change how your body feels and responds to pain. Acetaminophen is a less potent pain reliever that increases the effects of oxycodone. Acetaminophen can also help reduce a fever.

Roxicet is a prescription medicine used to relieve moderate to severe pain.

Roxicet works best if used at the first sign of pain occuring. If you wait until the pain has worsened, the medication may not work as well.

You should not use Roxicet if you have recently used alcohol, sedatives, tranquilizers, or other narcotic medications.

Roxicet can slow or stop your breathing, and may be habit-forming. Use only your prescribed dose, and swallow the tablet whole to avoid a potentially fatal dose. Never share Roxicet with another person.

MISUSE OF OPIOID MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it.

Do not take more Roxicet than is recommended. An overdose of acetaminophen can damage your liver or cause death. Call your doctor at once if you have nausea, pain in your upper stomach, itching, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of your skin or eyes).

Oxycodone may cause life-threatening withdrawal symptoms in a newborn if the mother has taken Roxicet during pregnancy.

An overdose of acetaminophen can damage your liver or cause death. Call your doctor at once if you have pain in your upper stomach, loss of appetite, dark urine, or jaundice (yellowing of your skin or eyes).

Stop taking Roxicet and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling.

Fatal side effects can occur if you use this medicine with alcohol, or with other drugs that cause drowsiness or slow your breathing.

Take Roxicet exactly as prescribed by your doctor. Follow all directions on your prescription label. Never take this medicine in larger amounts, or for longer than prescribed. An overdose can damage your liver or cause death. Tell your doctor if you feel an increased urge to use more of this medicine.

Never share Roxicet with another person, especially someone with a history of drug abuse or addiction. MISUSE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medicine in a place where others cannot get to it. Selling or giving away Roxicet is against the law.

Measure Roxicet Oral Solution, carefully. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

If you need surgery or medical tests, tell the doctor ahead of time that you are using this medicine.

You should not stop using Roxicet suddenly. Follow your doctor's instructions about tapering your dose.

Store at room temperature away from moisture and heat. Keep track of your medicine. You should be aware if anyone is using it improperly or without a prescription.

Do not keep leftover Roxicet. Just one dose can cause death in someone using this medicine accidentally or improperly. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, flush the unused medicine down the toilet.

Usual Adult Dose for Pain:

Immediate-release:
Oxycodone 5 mg/acetaminophen 325 mg: 1 tablet orally every 6 hours as needed for pain
Maximum dose: 12 tablets in 24 hours

Oral Solution: Oxycodone 5 mg/acetaminophen 325 mg per 5 mL:
Usual dose: Oxycodone 5 mg/acetaminophen 325 mg (5 mL) orally every 6 hours as needed for pain
Maximum dose: Oxycodone 60 mg/acetaminophen 3900 mg (60 mL) in 24 hours
-Verify dose in mg and mL prior to administration

-Because of the risks of addiction, abuse and misuse, the lowest effective dose for the shortest duration consistent with individual patient treatment goals should be used.
-Monitor patients closely for respiratory depression within the first 24 to 72 hours of initiating therapy and following any increase in dose.

Use: For the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

You should not use Roxicet if you are allergic to acetaminophen or oxycodone, or if you have:

• severe asthma or breathing problems; or

• a blockage in your stomach or intestines.

To make sure Roxicet is safe for you, tell your doctor if you have ever had:

• breathing problems, sleep apnea;

• liver disease;

• a drug or alcohol addiction;

• kidney disease;

• a head injury or seizures;

• urination problems; or

• problems with your thyroid, pancreas, or gallbladder.

If you use opioid medicine while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on opioids may need medical treatment for several weeks.

Do not breastfeed. Oxycodone can pass into breast milk and cause drowsiness, breathing problems, or death in a nursing baby.

Since Roxicet is used for pain, you are not likely to miss a dose. Skip any missed dose if it is almost time for your next dose. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of acetaminophen and oxycodone can be fatal.

The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.

Overdose can also cause severe muscle weakness, pinpoint pupils, very slow breathing, extreme drowsiness, or coma.

Avoid driving or operating machinery until you know how Roxicet will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Do not drink alcohol. Dangerous side effects or death could occur.

Ask a doctor or pharmacist before using any other medicine that may contain acetaminophen (sometimes abbreviated as APAP). Taking certain medications together can lead to a fatal overdose.

Get emergency medical help if you have signs of an allergic reaction to Roxicet: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Opioid medicine can slow or stop your breathing, and death may occur. A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

In rare cases, acetaminophen may cause a severe skin reaction that can be fatal. This could occur even if you have taken acetaminophen in the past and had no reaction. Stop taking this medicine and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling.

Call your doctor at once if you have:

• noisy breathing, sighing, shallow breathing, breathing that stops during sleep;

• a light-headed feeling, like you might pass out;

• weakness, tiredness, fever, unusual bruising or bleeding;

• confusion, unusual thoughts or behavior;

• problems with urination;

• liver problems - nausea, upper stomach pain, tiredness, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

• low cortisol levels - nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Serious side effects may be more likely in older adults and those who are overweight, malnourished, or debilitated.

Long-term use of opioid medication may affect fertility (ability to have children) in men or women. It is not known whether opioid effects on fertility are permanent.

Common Roxicet side effects include:

• dizziness, drowsiness, feeling tired;

• feelings of extreme happiness or sadness;

• nausea, vomiting, stomach pain;

• constipation; or

• headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

You may have breathing problems or withdrawal symptoms if you start or stop taking certain other medicines. Tell your doctor if you also use an antibiotic, antifungal medication, heart or blood pressure medication, seizure medication, or medicine to treat HIV or hepatitis C.

Opioid medication can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:

• cold or allergy medicines, bronchodilator asthma/COPD medication, or a diuretic ("water pill");

• medicines for motion sickness, irritable bowel syndrome, or overactive bladder;

• other narcotic medications - opioid pain medicine or prescription cough medicine;

• a sedative like Valium - diazepam, alprazolam, lorazepam, Xanax, Klonopin, Versed, and others;

• drugs that make you sleepy or slow your breathing - a sleeping pill, muscle relaxer, medicine to treat mood disorders or mental illness;

• drugs that affect serotonin levels in your body - a stimulant, or medicine for depression, Parkinson's disease, migraine headaches, serious infections, or nausea and vomiting.

This list is not complete. Other drugs may interact with acetaminophen and oxycodone, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.