Acetaminophen and oxycodone is a combination medicine used to relieve moderate to severe pain.

Acetaminophen and oxycodone contains an opioide medicine and may be habit-forming.

Acetaminophen and oxycodone may also be used for purposes not listed in this medication guide.

You should not use this medicine if you are allergic to acetaminophen or oxycodone, or if you have:

• severe asthma or breathing problems; or
• a blockage in your stomach or intestines.

Tell your doctor if you have ever had:

• breathing problems, sleep apnea;
• liver disease;
• a drug or alcohol addiction;
• kidney disease;
• a head injury or seizures;
• urination problems; or
• problems with your thyroid, pancreas, or gallbladder.

If you use opioid medicine 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 opioids may need medical treatment for several weeks.

Ask a doctor before using opioid medicine if you are breastfeeding. Tell your doctor if you notice severe drowsiness or slow breathing in the nursing baby.

Use Endocet 2.5/325 (Oral) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

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

Opioid medicine 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.

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

Call your doctor at once if you have:

• noisy breathing, sighing, shallow breathing, breathing that stops;
• a light-headed feeling, like you might pass out;
• weakness, tiredness, fever, unusual bruising or bleeding;
• confusion, unusual thoughts or behavior;
• problems with urination;
• liver problems--nausea, upper stomach pain, tiredness, 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 side effects include:

• dizziness, drowsiness, feeling tired;
• feelings of extreme happiness or sadness;
• nausea, vomiting, stomach pain;
• constipation; or
• headache.

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.

Avoid driving or operating machinery until you know how this medicine will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Do not drink alcohol. Dangerous side effects or death could occur.

Ask a doctor or pharmacist before using any other medicine that may contain acetaminophen (sometimes abbreviated as APAP). Taking certain medications together can lead to a fatal overdose.