• A strong prescription pain medicine that contains an opioid (narcotic) that is used for the management pain in adults, 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.

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

• Do not give ULTRAM to a child younger than 12 years of age.
• Do not give ULTRAM to a child younger than 18 years of age after surgery to remove the tonsils and/or adenoids.
• Avoid giving ULTRAM to children between 12 to 18 years of age who have risk factors for breathing problems such as obstructive sleep apnea, obesity, or underlying lung problems.

• Severe asthma, trouble breathing, or other lung problems.
• A bowel blockage or have narrowing of the stomach or intestines.
• An allergy to tramadol.
• Taken a Monoamine Oxidase Inhibitor, MAOI, (medicine used for depression) within the last 14 days.

Tell your healthcare provider if you are:

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

• Do not change your dose. Take ULTRAM exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed.
• Take your prescribed dose as indicated by your healthcare provider. The maximum dosage is 1 or 2 tablets every 4 to 6 hours, as needed for pain relief. Do not take more than your prescribed dose and do not take more than 8 tablets per day. 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 ULTRAM regularly, do not stop taking ULTRAM without talking to your healthcare provider.
• After you stop taking ULTRAM, ask your pharmacist how to dispose of any unused tablets.

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