OXAYDO- oxycodone hydrochloride tablet 
Egalet US Inc.

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This Medication Guide has been approved by the U.S. Food and Drug Administration. Issued: 12/2016

Medication Guide

OXAYDO (ox Ā doe)
(oxycodone HCl, USP) Tablets for oral use only, CII

OXAYDO is:

  • A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage short term (acute) and long term (chronic) pain severe enough to require an opioid pain medicine, 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 OXAYDO:

  • Get emergency help right away if you take too much OXAYDO (overdose). When you first start taking OXAYDO, 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.
  • Taking OXAYDO 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 OXAYDO. They could die from taking it. Store OXAYDO away from children and in a safe place to prevent stealing or abuse. Selling or giving away OXAYDO is against the law.

Do not take OXAYDO if you have:

  • severe asthma, trouble breathing, or other lung problems.
  • a bowel blockage or have narrowing of the stomach or intestines.

Before taking OXAYDO, tell your healthcare provider if you have a history of:

  • head injury, seizures
  • problems urinating
  • abuse of street or prescription drugs, alcohol addiction, or mental health problems.
  • liver, kidney, thyroid problems
  • pancreas or gallbladder problems

Tell your healthcare provider if you are:

  • pregnant or planning to become pregnant. Prolonged use of OXAYDO during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.
  • breastfeeding. Not recommended during treatment with OXAYDO. It may harm your baby.
  • taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking OXAYDO with certain other medicines can cause serious side effects that could lead to death.

When taking OXAYDO:

  • Do not change your dose. Take OXAYDO exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed.
  • Take your prescribed dose exactly as instructed by your healthcare provider. Your healthcare provider may adjust the dose until it is right for you. 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 OXAYDO regularly, do not stop taking OXAYDO without talking to your healthcare provider.
  • After you stop taking OXAYDO, destroy the unused tablets by flushing them down the toilet.

While taking OXAYDO DO NOT:

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

The possible side effects of OXAYDO:

  • 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, 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 OXAYDO. 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


Distributed by: Egalet US Inc., Wayne, PA, 19087; for more information go to www.oxaydo.com or call 1-800-518-1084


Revised: 12/2016
Egalet US Inc.