Codeine is an opioid pain medication. An opioid is sometimes called a narcotic. Acetaminophen is a less potent pain reliever that increases the effects of codeine.

The combination of acetaminophen and codeine is used to relieve moderate to severe pain.

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

Tell your doctor if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You may not be able to take acetaminophen.

Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death.

Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen.

Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP.

Codeine may be habit-forming and should be used only by the person it was prescribed for. Keep the medication in a secure place where others cannot get to it.

This medication may impair your thinking or reactions. Avoid driving or operating machinery until you know how acetaminophen and codeine will affect you.

Do not use this medication if you are allergic to acetaminophen (Tylenol) or codeine.

Codeine may be habit-forming and should be used only by the person it was prescribed for. Never share acetaminophen and codeine with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.

Tell your doctor if you drink more than three alcoholic beverages per day or if you have ever had alcoholic liver disease (cirrhosis). You may not be able to take medication that contains acetaminophen.

If you have any of these other conditions, you may need a dose adjustment or special tests:

• asthma, COPD, sleep apnea, or other breathing disorders;

• liver or kidney disease;

• a history of head injury or brain tumor;

• epilepsy or other seizure disorder;

• low blood pressure;

• a stomach or intestinal disorder;

• underactive thyroid;

• Addison's disease or other adrenal gland disorder;

• enlarged prostate, urination problems;

• curvature of the spine;

• mental illness; or

• a history of drug or alcohol addiction.

FDA pregnancy category C. It is not known whether this medication is harmful to an unborn baby, but it could cause breathing problems or addiction/withdrawal symptoms in a newborn. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

Acetaminophen and codeine can pass into breast milk and may harm a nursing baby. The use of codeine by some nursing mothers may lead to life-threatening side effects in the baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.