• 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.

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

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

• 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 EMBEDA 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 EMBEDA. It may harm your baby.
• taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking EMBEDA with certain other medicines can cause serious side effects and could lead to death.

• Do not change your dose. Take EMBEDA exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed.
• Take your prescribed dose every 12 or 24 hours, at the same time every day, as instructed by your healthcare provider. Do not take more than your prescribed daily dose within a 24-hour period. If you miss a dose, take your next dose at your usual time.
• Swallow EMBEDA whole. Do not cut, break, chew, crush, dissolve, snort, or inject EMBEDA because this may cause you to overdose and die.
• You should not receive EMBEDA through a nasogastric tube or gastric tube (stomach tube).
• If you cannot swallow EMBEDA capsules, see the detailed Instructions for Use.
• Call your healthcare provider if the dose you are taking does not control your pain.
• Do not stop taking EMBEDA without talking to your healthcare provider.
• Dispose of expired, unwanted, or unused EMBEDA 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.

• Drive or operate heavy machinery until you know how EMBEDA affects you. EMBEDA can make you sleepy, dizzy, or lightheaded.
• Drink alcohol, or use prescription or over-the-counter medicines containing alcohol. Using products containing alcohol during treatment with EMBEDA may cause you to overdose and die.