Oxymorphone hydrochloride 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.

Important information about oxymorphone hydrochloride extended-release tablets:

• Get emergency help right away if you take too many oxymorphone hydrochloride extended-release tablets (overdose). When you first start taking oxymorphone hydrochloride 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.
• Taking oxymorphone hydrochloride extended-release 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 oxymorphone hydrochloride extended-release tablets. They could die from taking it. Selling or giving away oxymorphone hydrochloride extended-release tablets is against the law.
• Store oxymorphone hydrochloride extended-release 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 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 oxymorphone hydrochloride 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 oxymorphone hydrochloride extended-release tablets 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 oxymorphone hydrochloride extended-release tablets. It may harm your baby.
• taking prescription or over-the-counter medicines, vitamins, or herbal supplements.  Taking oxymorphone hydrochloride extended-release tablets with certain other medicines can cause serious side effects that could lead to death. 

When taking oxymorphone hydrochloride extended-release tablets:

• Do not change your dose. Take oxymorphone hydrochloride extended-release tablets exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed.
• Take your prescribed dose every 12 hours at the same time every day on an empty stomach, at least 1 hour before or 2 hours after meals. Do not take more than your prescribed dose in 24 hours. If you miss a dose, take your next dose at your usual time.
• Swallow oxymorphone hydrochloride extended-release tablets whole. Do not cut, break, chew, crush, dissolve, snort, or inject oxymorphone hydrochloride extended-release tablets because this may cause you to overdose and die.
• Call your healthcare provider if the dose you are taking does not control your pain.
• Do not stop taking oxymorphone hydrochloride extended-release tablets without talking to your healthcare provider.
• Dispose of expired, unwanted, or unused oxymorphone hydrochloride extended-release 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 extended-release tablets DO NOT:

• Drive or operate heavy machinery, until you know how oxymorphone hydrochloride extended-release tablets affect you. Oxymorphone hydrochloride 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 oxymorphone hydrochloride extended-release tablets may cause you to overdose and die.