Acetaminophen is a pain reliever and a fever reducer.

Caffeine is used in this product to increase the pain relieving effects of acetaminophen.

Excedrin Tension Headache Express Gels is a combination medicine used to treat many conditions such as headache or muscle pain.

Excedrin Tension Headache Express Gels may also be used for purposes not listed in this medication guide.

Do not take 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).

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.

In rare cases, acetaminophen may cause a severe skin 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.

Use this medication exactly as directed on the label, or as 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.

The orally disintegrating tablet (Excedrin QuickTabs) should be placed directly on the tongue. Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing. Swallow several times as the tablet dissolves. If desired, you may drink liquid to help swallow the dissolved tablet.

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.

Acetaminophen may cause false urine glucose test results. Talk to your doctor if you have diabetes and you notice changes in glucose test results while taking Excedrin Tension Headache Express Gels.

Store at room temperature away from heat and moisture.

You should not take Excedrin Tension Headache Express Gels if you are allergic to it.

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

• liver disease or cirrhosis;

• stomach ulcer;

• a history of alcoholism; or

• if you drink more than 3 alcoholic beverages per day.

It is not known whether this medicine will harm an unborn baby. Do not take Excedrin Tension Headache Express Gels without medical advice if you are pregnant.

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

Since Excedrin Tension Headache Express Gels is taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take 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.

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.

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

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: 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 Tension Headache Express Gels 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.

Excedrin Tension Headache Express Gels may cause serious side effects. Stop using Excedrin Tension Headache Express Gels and call your doctor at once if you have:

• low fever with nausea, stomach pain, and loss of appetite;

• dark urine, clay-colored stools; or

• jaundice (yellowing of the skin or eyes).

Common side effects of Excedrin Tension Headache Express Gels may include:

• sleep problems (insomnia); or

• feeling nervous, irritable, or jittery.

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 acetaminophen and caffeine, 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.