Excedrin contains a combination of acetaminophen, aspirin, and caffeine. Acetaminophen is a pain reliever and a fever reducer. Aspirin is in a group of drugs called salicylates. It works by reducing substances in the body that cause pain, fever, and inflammation. Caffeine is a central nervous system stimulant. It relaxes muscle contractions in blood vessels to improve blood flow.

Excedrin is used to treat pain caused by tension headaches, migraine headaches, muscle aches, menstrual cramps, arthritis, toothaches, the common cold, or nasal congestion.

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

Do not give Excedrin to a child or teenager with a fever, flu symptoms, or chicken pox. Aspirin can cause Reye's syndrome, a serious and sometimes fatal condition in children.

Do not take more Excedrin 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).

Aspirin may cause stomach or intestinal bleeding, which can be fatal. Call your doctor at once if you have symptoms such as bloody or tarry stools, or coughing up blood or vomit that looks like coffee grounds.

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

Before taking this medicine

Do not give Excedrin to a child or teenager with a fever, flu symptoms, or chicken pox. Aspirin can cause Reye's syndrome, a serious and sometimes fatal condition in children.

You should not use Excedrin if you are allergic to acetaminophen (Tylenol), aspirin, caffeine, or any NSAIDs (Advil, Motrin, Aleve, Orudis, Indocin, Lodine, Voltaren, Toradol, Mobic, Relafen, Feldene, and others).

Aspirin may cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are taking Excedrin.

Ask a doctor or pharmacist if it is safe for you to take Excedrin if you have other medical conditions, especially:

• liver disease, cirrhosis, a history of alcoholism, or if you drink more than 3 alcoholic beverages per day;

• asthma or seasonal allergies;

• fever with a stiff neck;

• stomach ulcer, stomach or intestinal bleeding, ulcerative colitis;

• a bleeding or blood clotting disorder such as hemophilia;

• kidney disease; or

• if you use medicine to treat glaucoma or prevent blood clots.

If you take Excedrin to treat headache pain, seek medical attention if you have:

• a headache so bad you have to lie down;

• a headache that causes vomiting;

• what feels like the worst headache you've ever had;

• a headache that seems different from your usual headaches;

• a headache every day;

• a headache after coughing, bending, exercising, or head injury;

• if you have never had migraines diagnosed by a doctor; or

• if you are having your first headache after age 50.

Aspirin may be harmful to an unborn baby's heart, and may also reduce birth weight or have other dangerous effects. Tell your doctor if you are pregnant or plan to become pregnant while you are taking Excedrin.

Aspirin, acetaminophen, and caffeine can pass into breast milk and may harm a nursing baby. You should not breast-feed while using Excedrin.

Use Excedrin exactly as directed on the label, or as it has been prescribed by your doctor. Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death.

Take Excedrin with food or milk if it makes your stomach upset.

Call your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever lasting longer than 3 days, or any swelling or pain lasting longer than 10 days.

This medication can cause unusual results with certain lab tests for glucose (sugar) in the urine. Tell any doctor who treats you that you are using Excedrin.

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

Store Excedrin at room temperature away from moisture and heat.

Do not give Excedrin to a child or teenager with a fever, flu symptoms, or chicken pox. Aspirin can cause Reye's syndrome, a serious and sometimes fatal condition in children.

You should not use Excedrin if you are allergic to acetaminophen (Tylenol), aspirin, caffeine, or any NSAIDs (Advil, Motrin, Aleve, Orudis, Indocin, Lodine, Voltaren, Toradol, Mobic, Relafen, Feldene, and others).

Aspirin may cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are taking Excedrin.

Ask a doctor or pharmacist if it is safe for you to take Excedrin if you have other medical conditions, especially:

• liver disease, cirrhosis, a history of alcoholism, or if you drink more than 3 alcoholic beverages per day;

• asthma or seasonal allergies;

• fever with a stiff neck;

• stomach ulcer, stomach or intestinal bleeding, ulcerative colitis;

• a bleeding or blood clotting disorder such as hemophilia;

• kidney disease; or

• if you use medicine to treat glaucoma or prevent blood clots.

If you take Excedrin to treat headache pain, seek medical attention if you have:

• a headache so bad you have to lie down;

• a headache that causes vomiting;

• what feels like the worst headache you've ever had;

• a headache that seems different from your usual headaches;

• a headache every day;

• a headache after coughing, bending, exercising, or head injury;

• if you have never had migraines diagnosed by a doctor; or

• if you are having your first headache after age 50.

Aspirin may be harmful to an unborn baby's heart, and may also reduce birth weight or have other dangerous effects. Tell your doctor if you are pregnant or plan to become pregnant while you are taking Excedrin.

Aspirin, acetaminophen, and caffeine can pass into breast milk and may harm a nursing baby. You should not breast-feed while using Excedrin.

Since Excedrin is used when needed, you may not be on a dosing schedule. If you are on a schedule, 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 damage your liver or cause death.

The first signs of an acetaminophen 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.

Overdose symptoms may also include ringing in your ears, headache, diarrhea, hallucinations, fast or slow heart rate, or seizure (convulsions).

Avoid drinking alcohol while you are taking Excedrin. Alcohol may increase your risk of stomach bleeding while taking aspirin, or liver damage while taking acetaminophen.

Ask a doctor or pharmacist before using any other cough, cold, allergy, pain, menstrual symptom, or fever 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. Aspirin and caffeine are also contained in many combination medicines. Check the label to see if a medicine contains acetaminophen, APAP, aspirin, or caffeine.

Avoid taking another NSAID (nonsteroidal anti-inflammatory drug) such as aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.

Avoid coffee, tea, cola, energy drinks or other sources of caffeine while taking this medication. They can add to the side effects of the caffeine in the medication.

Get emergency medical help if you have any of these signs of an allergic reaction to Excedrin: 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 Excedrin 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 acetaminophen.

Stop using Excedrin and call your doctor at once if you have:

• severe anxiety, agitation, confusion, panic;

• easy bruising or bleeding;

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

• if you feel very thirsty or hot, are unable to urinate, and have heavy sweating or hot and dry skin;

• symptoms of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;

• high potassium--slow heart rate, weak pulse, muscle weakness, tingly feeling; or

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

Common Excedrin side effects may include:

• upset stomach, heartburn;

• depressed mood, feeling anxious or restless; or

• sleep problems (insomnia).

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 interact with Excedrin, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.