About Covidien's Mallinckrodt Business

Mallinckrodt LLC is the Pharmaceuticals business of Covidien, a global healthcare products company. We are proud to be the world's largest supplier of both controlled substance pain medication and acetaminophen and to have over a century of leadership in helping to diagnose disease through imaging procedures.

Our mission is to make diagnostics and medicines better and safer for you and your family. Our strategy is to provide patients with access to advanced medications that expand the limits of therapy by combining proven drugs with innovative delivery systems.

For more than 140 years, the Mallinckrodt name has been synonymous with high quality, innovative pharmaceutical products, and we continue to strive to deliver value through clinical leadership and excellence in everything we do.

For more information, please visit pharmaceuticals.covidien.com.

You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit http://www.fda.gov/medwatch, or call 1-800-FDA-1088.

Scroll down for Important Risk Information including boxed warning

INDICATION

EXALGO® is a strong opioid pain medicine. EXALGO is used in people who are opioid tolerant. EXALGO is used to manage moderate to severe pain that is continuous and is expected to last for a long time.

IMPORTANT RISK INFORMATION

IMPORTANT WARNINGS

Potential for Abuse

EXALGO is a federally controlled substance (CII). It contains hydromorphone, a strong opioid drug. Prevent theft, misuse, or abuse. Keep EXALGO in a safe place to protect it from theft. EXALGO can be a target for people who misuse or abuse prescription medicines or street drugs. Never give EXALGO to others, even if they have the same symptoms you have. It may harm them or cause death. Selling or giving away this medicine is against the law.

Proper Patient Selection

EXALGO is used in people who are opioid tolerant to help them manage moderate to severe pain that is continuous and is expected to last for a long time. Opioid tolerant means you are already regularly taking opioid pain medicine around-the-clock. Opioid tolerant also means that your body is used to taking these medicines.

Do not use EXALGO if you are NOT opioid tolerant. Use of EXALGO by people who are not opioid tolerant can cause life-threatening breathing problems that can cause death.

IMPORTANT: Keep EXALGO in a safe place away from children. Accidental use by a child is a medical emergency and can cause death. If a child accidentally takes EXALGO, get emergency help right away, even if the child is not having any side effects.

Limitations of Use

EXALGO is not for use to treat pain that you only have once in a while ("as needed").

EXALGO is not for use for short-term pain relief from injuries or surgery.

Swallow the EXALGO tablet whole. Do not break, chew, crush, or dissolve EXALGO before swallowing. Do not inject the contents. You could receive the full daily dose of medicine too fast. This is very dangerous. It may cause you to have trouble breathing and lead to death. Tell your doctor if you cannot swallow EXALGO whole. You will need a different pain medicine.

  • You should also not take EXALGO if you:
    • - need management of mild pain or pain that is not expected to continue for a long time
    • - are having an asthma attack or have severe asthma, trouble breathing, or certain other lung problems
    • - have or are suspected to have a bowel blockage called paralytic ileus
    • - have narrowing of the stomach or intestines
    • - have had surgery to your stomach or intestines
    • - are allergic to any of the ingredients in EXALGO or to medicines that contain sulfite. See the Medication Guide for EXALGO for a complete list of its ingredients.
  • Do not drive or operate heavy machinery or other dangerous activities until you know how EXALGO affects you. EXALGO can make you sleepy and cause you to feel dizzy or lightheaded. This may affect your ability to think and react.
  • Do not drink alcohol or use prescription or non-prescription medicines that contain alcohol while taking EXALGO. Using alcohol while taking EXALGO may cause overdose and death.
  • Do not take EXALGO if you already take a monoamine oxidase inhibitor medicine (MAOI). Do not take EXALGO within 14 days after you stop taking an MAOI medicine.
  • Tell your healthcare provider about all your medicines. This includes prescription and non-prescription medicines, vitamins, and herbal supplements. Some medicines may cause serious or life-threatening medical problems when taken with EXALGO.
  • Breathing problems, which occur more often in older people or weakened patients, is the chief hazard with EXALGO. Call your doctor or get emergency medical help if you have any symptoms listed below. It can mean that you have taken too much (overdose) EXALGO. You have trouble breathing. You have extreme drowsiness with slowed breathing. You have shallow breathing (little chest movement with breathing). You feel faint, dizzy, or confused. You have other unusual symptoms.
  • Common side effects of EXALGO include constipation, nausea, vomiting, drowsiness or sleepiness, headache and dizziness. Serious events can include drop in blood pressure, symptoms of stomach or intestinal blockage, allergic reactions, and physical dependence symptoms from stopping EXALGO all at once.

Please see Medication Guide for Important Risk Information and Full Prescribing Information.

IMPORTANT RISK INFORMATION

IMPORTANT WARNINGS

Potential for Abuse

EXALGO® is a federally controlled substance (CII). It contains hydromorphone, a strong opioid drug. Prevent theft, misuse, or abuse.
Keep EXALGO in a safe place to protect it from theft. Click here for more Important Risk Information, including boxed warning