OXYMORPHONE HYDROCHLORIDE- oxymorphone hydrochloride tablet 
West-Ward Pharmaceuticals Corp.

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Medication Guide

Oxymorphone Hydrochloride Tablets, for oral use, CII

(ox” i mor’ fone hye” droe klor’ ide)

Rx only

Oxymorphone hydrochloride is:

A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage short-term (acute) pain 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 oxymorphone hydrochloride:

Get emergency help or call 911 right away if you take too much oxymorphone hydrochloride (overdose). When you first start taking oxymorphone hydrochloride, 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 oxymorphone hydrochloride 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 oxymorphone hydrochloride tablets. They could die from taking it. Selling or giving away oxymorphone hydrochloride tablets is against the law.
Store oxymorphone hydrochloride tablets securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home.

Do not take oxymorphone hydrochloride if you have:

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

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

head injury, seizures
problems urinating
liver, kidney, thyroid problems
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:

pregnant or planning to become pregnant. Prolonged use of oxymorphone hydrochloride during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.
breastfeeding. Oxymorphone hydrochloride passes into breast milk and may harm your baby.
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 oxymorphone hydrochloride with certain other medicines can cause serious side effects that could lead to death.

When taking oxymorphone hydrochloride:

Do not change your dose. Take oxymorphone hydrochloride exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed.
Oxymorphone hydrochloride should be taken on an empty stomach, at least one hour prior to or two hours after eating.
Take your prescribed dose at the same time every day. 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 oxymorphone hydrochloride regularly, do not stop taking oxymorphone hydrochloride without talking to your healthcare provider.
Dispose of expired, unwanted, or unused oxymorphone hydrochloride tablets 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 oxymorphone hydrochloride DO NOT:

Drive or operate heavy machinery, until you know how oxymorphone hydrochloride affects you. Oxymorphone hydrochloride 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 oxymorphone hydrochloride may cause you to overdose and die.

The possible side effects of oxymorphone hydrochloride:

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 or hands, hives, itching, rash, 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 oxymorphone hydrochloride. 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

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

Distr. by: West-Ward

Pharmaceuticals Corp.

Eatontown, NJ 07724

10005444/08

Revised July 2020

Revised: 7/2021
West-Ward Pharmaceuticals Corp.