Excedrin Extra Strength

Acetaminophen is a pain reliever and a fever reducer. Aspirin is a salicylate (sa-LIS-il-ATE). Caffeine is a stimulant for the central nervous system.

Excedrin Extra Strength is a combination medicine used to treat pain from tension headaches, migraine headaches, muscle aches, menstrual cramps, arthritis, toothaches, the common cold, or nasal congestion.

Do not use aspirin for heart or blood vessel conditions unless your doctor tells you to.

Excedrin Extra Strength may also be used for reasons not listed in this medication guide.

Use exactly as directed on the label, or as prescribed by your doctor. Never use more than the recommended dose. An overdose of acetaminophen can damage your liver or cause death.

Take with food or milk if the medicine upsets your stomach.

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

Overuse of migraine headache medicine (more than 10 days per month) can make headaches worse. Tell your doctor if this medicine seems to stop working as well.

This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using Excedrin Extra Strength.

If you need surgery, dental work, or a medical procedure, you may need to stop taking this medicine for a short time.

Store at room temperature away from moisture and heat.

Do not give this medicine to a child or teenager who has a fever, flu symptoms, or chicken pox. Aspirin can lead to Reye's syndrome, a serious and sometimes deadly condition in children.

Do not take more than the recommended dose. An acetaminophen overdose can harm your liver or lead to death.

Call your doctor immediately if you experience: nausea, upper stomach pain, loss of appetite, dark urine, yellowing of your skin or eyes, clay-colored stools, bloody or tarry stools, coughing up blood, or vomit that looks like coffee grounds.

In rare instances, acetaminophen may cause a severe skin reaction. Stop taking this medicine and contact your doctor right away if you notice skin redness or a rash that spreads and causes blistering and peeling.

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

You should not use this medicine if you are allergic to acetaminophen (Tylenol), aspirin, caffeine, or any NSAIDs (diclofenac, ibuprofen, indomethacin, meloxicam, naproxen, Advil, Aleve, Motrin, and others).

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

Ask a doctor or pharmacist if this medicine is safe for you to use if you have ever had:

• 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;
• bleeding problems;
• kidney disease; or
• if you use medicine to treat glaucoma or to prevent blood clots.

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

• a headache so severe that 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 a head injury;
• if you have never had migraines diagnosed by a doctor; or
• if you are having your first headache after age 50.

Ask a doctor before using this medicine if you are pregnant or breastfeeding.

Taking aspirin during late pregnancy may cause bleeding in the mother or the baby during delivery. Ask a doctor before using this medicine if you are pregnant.

Do not give this medicine to anyone younger than 18 years old without medical advice.

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, acetaminophen may cause a severe skin reaction that can be fatal. This could happen even if you have taken acetaminophen before without any 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. If you have this type of reaction, you should never take any medicine that contains acetaminophen again.

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

• severe anxiety, agitation, confusion, panic;
• easy bruising or bleeding;
• a light-headed feeling, like you might pass out;
• dehydration symptoms--feeling very thirsty or hot, being unable to urinate, 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--nausea, weakness, tingly feeling, chest pain, irregular heartbeats, loss of movement; or
• liver problems--nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects of Excedrin Extra Strength 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 the FDA at 1-800-FDA-1088.

Since Excedrin Extra Strength is used as needed, you might not have a regular dosing schedule. If you miss a dose and it's nearly time for your next dose, just skip the missed dose. Do not take two doses at the same time.

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.

Early signs of acetaminophen overdose include loss of appetite, nausea, vomiting, sweating, or weakness. Later symptoms may include upper stomach pain, dark urine, and yellowing of your skin or eyes.

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

Avoid drinking alcohol. It may increase your risk of liver damage or stomach bleeding.

Ask a doctor or pharmacist before using other medicines for pain, fever, swelling, or cold/flu symptoms. They may contain ingredients similar to acetaminophen or aspirin (such as ibuprofen, ketoprofen, or naproxen).

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.

Other drugs may impact Excedrin Extra Strength, including both prescription and over-the-counter medicines, vitamins, and herbal products. Inform your doctor about all the medicines you are currently taking and any medicine you begin or discontinue using.