Acephen is a pain reliever and a fever reducer.

Acephen is given as a suppository to treat many conditions such as headache, muscle aches, arthritis, backache, toothaches, colds, and fevers.

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

Do not use 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).

In rare cases, Acephen may cause a severe skin reaction. Stop using this medicine and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

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

If you are treating a child, use a pediatric form of acetaminophen. Carefully follow the dosing directions on the medicine label.

Do not take a rectal suppository by mouth. It is for use only in your rectum.

Wash your hands before and after inserting the rectal suppository.

Remove the wrapper before inserting the suppository. Avoid handling the suppository too long or it will melt in your hands.

Gently insert the suppository into your rectum, pointed tip first.

For best results, stay lying down for a few minutes. The suppository will melt quickly and you should feel little or no discomfort while holding it in.

Stop using Acephen and call your doctor if:

• you still have a fever after 3 days of use;

• you still have pain after 10 days of use (or 5 days if treating a child);

• you have a sore throat, high fever, or nausea and vomiting;

• you have a skin rash, ongoing headache, or any redness or swelling; or

• if your symptoms get worse, or if you have any new symptoms.

The rectal suppositories may also be stored in the refrigerator. Do not allow the medicine to freeze.

Store at room temperature away from heat and moisture.

You should not use Acephen if you are allergic to it.

Do not use Acephen without a doctor's advice if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day.

Your doctor will determine whether Acephen is safe for you to use during pregnancy. Do not use Acephen without the advice of your doctor if you are pregnant.

Acetaminophen can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breastfeeding a baby.

Do not give this medicine to a child without medical advice.

Since Acephen is used as needed, you may not be on a dosing schedule. If you are using the medication regularly, use the missed dose as soon as you remember. Skip the 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 acetaminophen can be fatal.

The first signs of an Acephen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.

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

Avoid drinking alcohol. It may increase your risk of liver damage while using Acephen.

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

In rare cases, Acephen may cause a severe skin reaction that can be fatal. This could occur even if you have taken this medicine in the past and had no reaction. Stop using Acephen and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling. If you have this type of reaction, you should never again take any medicine that contains this medicine.

This medicine may cause serious side effects. Stop using this medicine and call your doctor at once if you have:

• nausea, upper stomach pain, loss of appetite;

• itching, dark urine, clay-colored stools; or

• jaundice (yellowing of the skin or eyes).

Less serious side effects may be more likely, and you may have none at all.

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.

Other drugs may affect Acephen, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.