OXYCODONE HYDROCHLORIDE- oxycodone hydrochloride tablet 


Oxycodone (ox-i-KOE-done) HCl Tablets USP, CII

Oxycodone HCl tablets are:

A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage 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 oxycodone HCl tablets:

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

Do not take oxycodone HCl tablets if you have:

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

Before taking oxycodone HCl tablets, 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 oxycodone HCl tablets during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.
breastfeeding. Oxycodone HCl passes into breast milk and may harm your baby.
taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking oxycodone HCl tablets with certain other medicines can cause serious side effects that could lead to death.

When taking oxycodone HCl tablets:

Do not change your dose. Take oxycodone HCl tablets exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed.
Take your prescribed dose every 4 to 6 hours. 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 oxycodone HCl tablets regularly, do not stop taking oxycodone HCl tablets without talking to your healthcare provider.
After you stop taking oxycodone HCl tablets, flush any unused tablets down the toilet.

While taking oxycodone HCl tablets DO NOT:

Drive or operate heavy machinery, until you know how oxycodone HCl tablets affects you. Oxycodone HCl 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 tablets may cause you to overdose and die.

The possible side effects of oxycodone HCl 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, 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 oxycodone HCl 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

Manufactured by:
Amneal Pharmaceuticals of NY LLC
Brookhaven, NY 11719

www.amneal.com or call 1-877-835-5472

This Medication Guide has been approved by the U.S. Food and Drug Administration.
Rev. 03-2017-00

Revised: 8/2019