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Medication Guide — ENDOCET

Patient-friendly FDA guidance and safety information.

Last updated · May 13, 2026Source: DailyMed ↗
Boxed Warning

WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF ENDOCET

Addiction, Abuse, and Misuse
 Because the use of ENDOCET exposes 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 and reassess all patients regularly for the development of these behaviors and conditions .

Life-Threatening Respiratory Depression
 Serious, life-threatening, or fatal respiratory depression may occur with use of ENDOCET, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of ENDOCET are essential .

Accidental Ingestion
 Accidental ingestion of even one dose of ENDOCET, especially by children, can result in a fatal overdose of Oxycodone .

Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants
Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of ENDOCET and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate .

Neonatal Opioid Withdrawal Syndrome (NOWS)
 If opioid use is required for an extended period of time in a pregnant woman, advise the patient of the risk of NOWS, which may be life-threatening if not recognized and treated. Ensure that management by neonatology experts will be available at delivery .

Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS)

Healthcare providers are strongly encouraged to complete a REMS-compliant education program and to counsel patients and caregivers on serious risks, safe use, and the importance of reading the Medication Guide  with each prescription .

Cytochrome P450 3A4 Interaction
 The concomitant use of ENDOCET with all cytochrome P450 3A4 inhibitors may result in an increase in oxycodone plasma concentrations, which could increase or prolong adverse reactions 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 ENDOCET and any CYP3A4 inhibitor or inducer .

Hepatotoxicity
 Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 mg per day, and often involve more than one acetaminophen-containing product.

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.

On this page

Revised: 06/2024

Medication Guide
 ENDOCET®  (ˈEn-dō-ˌset) (oxycodone and acetaminophen)  Tablets,
CII

ENDOCET is :

  • A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage pain, severe enough to require an opioid analgesic and for which alternative treatments are inadequate and when other pain treatments such as non-opioid pain medicines do not treat your pain well enough or you cannot tolerate them.
  • An 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.

Important information about ENDOCET tablets:

  • Get emergency help or call 911 right away if you take too much ENDOCET (overdose). When you first start taking ENDOCET, 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. Talk to your healthcare provider about naloxone, a medicine for the emergency treatment of an opioid overdose. Taking ENDOCET with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.
  • Never give anyone else your ENDOCET. They could die from taking it. Selling or giving away ENDOCET is against the law.
  • Store ENDOCET securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home.

Do not take ENDOCET if you have:

  • Severe asthma, trouble breathing, or other lung problems.
  • A bowel blockage or have narrowing of the stomach or intestines.
  • Known hypersensitivity to oxycodone, acetaminophen, or any ingredient in ENDOCET.

Before taking ENDOCET, 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, opioid overdose, or mental health problems

Tell your healthcare provider if you are:

  • Noticing your pain getting worse. If your pain gets worse after you take ENDOCET, do not take more of ENDOCET without first talking to your healthcare provider. Talk to your healthcare provider if the pain that you have increases, if you feel more sensitive to pain, or if you have new pain after taking ENDOCET.
  • Pregnant or planning to become pregnant. Use of ENDOCET for an extended period of time during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.
  • Breastfeeding. ENDOCET passes into breast milk and may harm your baby. Carefully observe infants for increased sleepiness (more than usual), breathing difficulties, or limpness. Seek immediate medical care if you notice these signs.
  • Living in a household where there are small children or someone who has abused street or prescription drugs.
  • Taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking ENDOCET with certain other medicines can cause serious side effects that could lead to death.

When taking ENDOCET:

  • Do not change your dose. Take ENDOCET exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed.
  • For acute (short-term) pain, you may only need to take ENDOCET for a few days. You may have some ENDOCET left over that you did not use. See disposal information at the bottom of this section for directions on how to safely throw away (dispose of) your unused ENDOCET.
  • Take your prescribed dose every 6 hours at the same time every day as needed for pain. Do not take more than your prescribed dose. If you miss a dose, take your next dose at your usual time.
  • Call your healthcare provider if the dose you are taking does not control your pain.
  • If you have been taking ENDOCET regularly, do not stop taking ENDOCET without talking to your healthcare provider.
  • Dispose of expired, unwanted, or unused ENDOCET by promptly flushing down the toilet, if a drug take-back option is not readily available. Visit www.fda.gov/drugdisposal for additional information on disposal of unused medicines.

While taking ENDOCET DO NOT:

  • Drive or operate heavy machinery, until you know how ENDOCET affects you. ENDOCET 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 ENDOCET may cause you to overdose and die.

The possible side effects of ENDOCET:

  • 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 or call 911 right away 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, feeling faint, agitation, high body temperature, trouble walking, stiff muscles, or mental changes such as confusion.

These are not all the possible side effects of ENDOCET. Call your healthcare provider 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, www.endo.com or call 1-800-828-9393.

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

Manufactured for:

Endo USA

Malvern, PA 19355

© 2024 Endo, Inc. or one of its affiliates.


Sources

RxCUI: 1049221

NDC: 63629-2189

Last fetched: May 13, 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.