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Medication Guide — Endocet, Nalocet, Oxaydo, Oxycontin, Percocet, Primlev, Prolate, Roxicodone, Roxybond

Patient-friendly FDA guidance and safety information.

Last updated · May 19, 2026Source: DailyMed ↗
Boxed Warning

WARNING: ADDICTION, ABUSE AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; AND CYTOCHROME P450 3A4 INTERACTION

Addiction, Abuse, and Misuse

OXYCODONE HCl EXTENDED-RELEASE TABLETS expose patients and other users to the risks of opioid addiction, abuse and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing OXYCODONE HCl EXTENDED-RELEASE TABLETS and monitor all patients regularly for the development of these behaviors or conditions.

Life-Threatening Respiratory Depression

Serious, life-threatening, or fatal respiratory depression may occur with use of OXYCODONE HCl EXTENDED-RELEASE TABLETS. Monitor for respiratory depression, especially during initiation of OXYCODONE HCl EXTENDED-RELEASE TABLETS or following a dose increase. Instruct patients to swallow OXYCODONE HCl EXTENDED-RELEASE TABLETS whole; crushing, chewing, or dissolving OXYCODONE HCl EXTENDED-RELEASE TABLETS can cause rapid release and absorption of a potentially fatal dose of oxycodone.

Accidental Ingestion

Accidental ingestion of even one dose of OXYCODONE HCl EXTENDED-RELEASE TABLETS, especially by children, can result in a fatal overdose of oxycodone.

Neonatal Opioid Withdrawal Syndrome

Prolonged use of OXYCODONE HCl EXTENDED-RELEASE TABLETS during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.

Cytochrome P450 3A4 Interaction

The concomitant use of OXYCODONE HCl EXTENDED-RELEASE TABLETS with all cytochrome P450 3A4 inhibitors may result in an increase in oxycodone plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in oxycodone plasma concentration. Monitor patients receiving OXYCODONE HCl EXTENDED-RELEASE TABLETS and any CYP3A4 inhibitor or inducer.

Poison Help

If you suspect an overdose or accidental ingestion, call Poison Control: 1-800-222-1222 (free, 24/7, U.S.). For life-threatening symptoms, call 911.

MEDICATION GUIDE

This Medication Guide has been approved by the U.S. Food and Drug Administration.

OXYCODONE Hydrochloride (ox-e-KO-don hye-droe-KLOR-ide) Extended-release Tablets, for oral use, CII

OXYCODONE HCl EXTENDED-RELEASE TABLETS are:

A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage pain severe enough to require daily around-the-clock, long-term treatment with an opioid, when other pain treatments such as non-opioid pain medicines or immediate-release opioid medicines do not treat your pain well enough or you cannot tolerate them.
A long-acting (extended-release) 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.
Not for use to treat pain that is not around-the-clock.
Not for use in children less than 11 years of age and who are not already using opioid pain medicines regularly to manage pain severe enough to require daily around-the-clock long-term treatment of pain with an opioid.

Important information about OXYCODONE HCl EXTENDED-RELEASE TABLETS:

Get emergency help right away if you take too much OXYCODONE HCl EXTENDED-RELEASE TABLETS (overdose). When you first start taking OXYCODONE HCl EXTENDED-RELEASE 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.
Never give anyone else your OXYCODONE HCl EXTENDED-RELEASE TABLETS. They could die from taking it. Store OXYCODONE HCl EXTENDED-RELEASE TABLETS away from children and in a safe place to prevent stealing or abuse. Selling or giving away OXYCODONE HCl EXTENDED-RELEASE TABLETS is against the law.

Do not take OXYCODONE HCl EXTENDED-RELEASE 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 HCl EXTENDED-RELEASE TABLETS, tell your healthcare provider if you have a history of:

head injury, seizures
liver, kidney, thyroid problems
problems urinating
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 HCl EXTENDED-RELEASE TABLETS during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.
breastfeeding. OXYCODONE HCl EXTENDED-RELEASE TABLETS pass into breast milk and may harm your baby.
taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking OXYCODONE HCl EXTENDED-RELEASE TABLETS with certain other medicines can cause serious side effects that could lead to death.

When taking oxycodone hydrochloride extended-release tablets:

Do not change your dose. Take OXYCODONE HCL EXTENDED-RELEASE TABLETS exactly as prescribed by your healthcare provider.
Take your prescribed dose every 12 hours at the same time every day. Do not take more than your prescribed dose in 12 hours. If you miss a dose, take your next dose at your usual time.
Swallow OXYCODONE HCL EXTENDED-RELEASE TABLETS whole. Do not cut, break, chew, crush, dissolve, snort, or inject OXYCODONE HCL EXTENDED-RELEASE TABLETS because this may cause you to overdose and die.
OXYCODONE HCL EXTENDED-RELEASE TABLETS should be taken 1 tablet at a time. Do not pre-soak, lick, or wet the tablet before placing in your mouth to avoid choking on the tablet.
Call your healthcare provider if the dose you are taking does not control your pain.
Do not stop taking OXYCODONE HCL EXTENDED-RELEASE TABLETS without talking to your healthcare provider.
After you stop taking OXYCODONE HCL EXTENDED-RELEASE TABLETS, flush any unused tablets down the toilet.

While taking OXYCODONE HCL EXTENDED-RELEASE TABLETS DO NOT:

Drive or operate heavy machinery, until you know how OXYCODONE HCL EXTENDED-RELEASE TABLETS affect you. OXYCODONE HCL EXTENDED-RELEASE 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 HCL EXTENDED-RELEASE TABLETS may cause you to overdose and die.

The possible side effects of OXYCODONE HCL EXTENDED-RELEASE TABLETS are:

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, or you are feeling faint.

These are not all the possible side effects of OXYCODONE HCL EXTENDED-RELEASE 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

Dist By: Impax Laboratories, Inc., Hayward, CA 94544

Rev. 08/2015
303911-0A

Sources

RxCUI: 1860157

NDC: 935731

Last fetched: May 19, 2026

Source: DailyMed ↗

⚠️ Disclaimer

This information is for educational purposes only and is not medical advice. Always consult your doctor, pharmacist, or other licensed healthcare professional before starting, stopping, or changing any medicine. Read full medical disclaimer.