Endocet contains a combination of acetaminophen and oxycodone. Oxycodone is an opioid pain medication. An opioid is sometimes called a narcotic. Acetaminophen is a less potent pain reliever that increases the effects of oxycodone.

Endocet is used to relieve moderate to severe pain.

Endocet may also be used for purposes not listed in this medication guide.

You should not use Endocet if you have recently used alcohol, sedatives, tranquilizers, or other opioid medications.

Ooxycodone can slow or stop your breathing, and may be habit-forming. Use only your prescribed dose, and swallow the pill whole to avoid a potentially fatal dose. Never share Endocet with another person.

MISUSE OF THIS MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription.

Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death. Call your doctor at once if you have nausea, pain in your upper stomach, itching, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of your skin or eyes).

Oxycodone may cause life-threatening withdrawal symptoms in a newborn if the mother has taken Endocet during pregnancy.

An overdose of acetaminophen can damage your liver or cause death. Call your doctor at once if you have nausea, pain in your upper stomach, itching, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of your skin or eyes).

Stop taking this medicine and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling.

Fatal side effects can occur if you use this medicine with alcohol, or with other drugs that cause drowsiness or slow your breathing.

Take Endocet exactly as prescribed. Follow all directions on your prescription label. Oxycodone can slow or stop your breathing, especially when you start using this medicine or whenever your dose is changed. Never use Endocet in larger amounts, or for longer than prescribed. An overdose can damage your liver or cause death. Tell your doctor if you feel an increased urge to use more of this medicine.

Oxycodone may be habit-forming, even at regular doses. Never share Endocet with another person, especially someone with a history of drug abuse or addiction. MISUSE OF OPIOID MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription. Selling or giving away Endocet is against the law.

If you need surgery, tell the surgeon ahead of time that you are using Endocet. You may need to stop using the medicine for a short time.

Do not stop using this medicine suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using the medicine.

Store Endocet at room temperature away from moisture and heat. Keep track of the amount of medicine used from each new bottle. Oxycodone is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

Do not keep leftover Endocet tablets. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, flush any unused tablets down the toilet.

Never crush or break an Endocet tablet to inhale the powder or mix it into a liquid to inject the drug into your vein.

You should not use Endocet if you are allergic to acetaminophen (Tylenol) or oxycodone, or if:

• you have severe asthma or breathing problems;

• you have a blockage in your stomach or intestines, including paralytic ileus; or

• you have recently used alcohol, sedatives, tranquilizers, or other opioid medications.

Some medicines can interact with oxycodone and cause a serious condition called serotonin syndrome. Be sure your doctor knows if you also take medicine for depression, mental illness, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting. Ask your doctor before making any changes in how or when you take your medications.

To make sure Endocet is safe for you, tell your doctor if you have:

• breathing problems, sleep apnea;

• liver disease, cirrhosis, or if you drink alcohol daily;

• a history of drug abuse, alcohol addiction, or mental illness;

• kidney disease, urination problems;

• problems with your gallbladder, pancreas, thyroid, or adrenal gland;

• a history of head injury, brain tumor, or seizures; or

• if you use a sedative like Valium (diazepam, alprazolam, lorazepam, Ativan, Klonopin, Restoril, Tranxene, Versed, Xanax, and others).

Endocet is more likely to cause breathing problems in older adults and people who are severely ill, malnourished, or otherwise debilitated.

If you use oxycodone while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on habit-forming medicine may need medical treatment for several weeks. You should not breastfeed while using this medicine.

Acetaminophen and oxycodone may pass into breast milk and could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Since Endocet is used for pain, you are not likely to miss a dose. Skip any missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of this medicine can be fatal, especially in a child or other person using the medicine without a prescription. Overdose symptoms may include nausea, vomiting, sweating, severe drowsiness, pinpoint pupils, slow breathing, or no breathing.

Your doctor may recommend you get naloxone (a medicine to reverse an opioid overdose) and keep it with you at all times. A person caring for you can give the naloxone if you stop breathing or don't wake up. Your caregiver must still get emergency medical help and may need to perform CPR (cardiopulmonary resuscitation) on you while waiting for help to arrive.

Anyone can buy naloxone from a pharmacy or local health department. Make sure any person caring for you knows where you keep naloxone and how to use it.

Get emergency medical help if you have signs of an allergic reaction to Endocet: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

In rare cases, acetaminophen may cause a severe skin reaction that can be fatal. This could occur even if you have taken acetaminophen in the past and had no reaction. Stop taking Endocet and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling.

Oxycodone can slow or stop your breathing, and death may occur. A person caring for you should give naloxone and/or seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

Call your doctor at once if you have:

• noisy breathing, sighing, shallow breathing, breathing that stops during sleep;

• a light-headed feeling, like you might pass out;

• confusion, unusual thoughts or behavior;

• seizure (convulsions);

• problems with urination;

• infertility, missed menstrual periods;

• impotence, sexual problems, loss of interest in sex;

• liver problems - nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• low cortisol levels - nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness; or

• high levels of serotonin in the body - agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, diarrhea.

Serious breathing problems may be more likely in older adults and in those who are debilitated or have wasting syndrome or chronic breathing disorders.

Common Endocet side effects include:

• headache, drowsiness, tiredness;

• nausea, vomiting, stomach pain, constipation;

• blurred vision; or

• dry mouth.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Opioids can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:

• other opioids - opioid pain medicine or prescription cough medicine;

• drugs that make you sleepy or slow your breathing - a sleeping pill, muscle relaxer, sedative, tranquilizer, or antipsychotic medicine; or

• drugs that affect serotonin levels in your body - medicine for depression, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting.

This list is not complete. Other drugs may interact with acetaminophen and oxycodone, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.