QDOLO is:

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

Important information about QDOLO:

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

Important Information Guiding Use in Pediatric Patients:

• Do not give QDOLO to a child younger than 12 years of age.
• Do not give QDOLO to anyone younger than 18 years of age after surgery to remove the tonsils, adenoids, or both.
• Avoid giving QDOLO 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.

Tell your healthcare provider if you are:

• noticing your pain getting worse. If your pain gets worse after you take QDOLO, do not take more of QDOLO without first talking to your healthcare provider. Talk to your healthcare provider if the pain that you have increases, if you feel more sensitive to pain, or if you have new pain after taking QDOLO.
• pregnant or planning to become pregnant. Use of QDOLO for an extended period of time 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 QDOLO; it may harm your baby.
• taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking QDOLO with certain other medicines can cause serious side effects that could lead to death.

When taking QDOLO:

• Do not change your dose. Take QDOLO exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed.
• For acute (short-term) pain, you may only need to take QDOLO for a few days. You may have some QDOLO left over that you did not use. See disposal information at the bottom of this section for directions on how to safely throw away (dispose of) your unused QDOLO.
• Always use a calibrated oral syringe or other oral dosing device obtained from your doctor or pharmacist to
  correctly measure your dose. Never use a household teaspoon or tablespoon to measure QDOLO.
• Take your prescribed dose as indicated by your healthcare provider. The maximum dosage is 10 mL to 20 mL every 4 to 6 hours, as needed for pain. Do not take more than your prescribed dose and do not take more than 80 mL 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 QDOLO regularly, do not stop taking QDOLO without talking to your healthcare provider.
• Dispose of expired, unwanted, or unused QDOLO by taking your drug to an authorized Drug Enforcement
  Administration (DEA)-registered collector or drug take-back program. If one is not available, you can dispose of
  QDOLO by mixing QDOLO with dirt, cat litter, or used coffee grounds; placing the mixture in a container such as a
  sealed plastic bag; and throwing the container in the household trash. Visit www.fda.gov/drugdisposalfor additional information on disposal of unused medicines.

While taking QDOLO DO NOT:

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

The possible side effects of QDOLO:

• constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, abdominal pain. Call your healthcare provider if you have any of these symptoms and they are severe.