Excedrin Tension Headache

Acetaminophen is a medicine that relieves pain and reduces fever.

Caffeine is included in this product to enhance the pain-relieving effects of acetaminophen.

Excedrin Tension Headache is a combination medicine used to treat various conditions like headache or muscle pain.

Excedrin Tension Headache may also be used for reasons not mentioned in this medication guide.

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.

Store at room temperature away from heat and moisture.

Do not take more of this medication than is recommended. Taking too much acetaminophen can harm your liver or lead to death. Call your doctor immediately if you experience nausea, pain in your upper stomach, itching, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of your skin or eyes).

Before using any other cold, allergy, pain, or sleep medication, ask a doctor or pharmacist. Acetaminophen (sometimes called APAP) is found in many combination medicines. Taking certain products together can result in too much acetaminophen, which can cause a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP.

In rare instances, acetaminophen may lead to a serious skin reaction. If you notice skin redness or a rash that spreads and causes blistering and peeling, stop taking this medicine and call your doctor right away.

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

Ask a doctor or pharmacist if it is safe for you to take Excedrin Tension Headache 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 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.

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 happen even if you have taken acetaminophen before and had no reaction. Stop taking Excedrin Tension Headache 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 may cause serious side effects. Stop using Excedrin Tension Headache and call your doctor immediately 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 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.

Since Excedrin Tension Headache is taken as needed, you may not have a regular dosing schedule. If you are taking the medication regularly and miss a dose, take it as soon as you remember. If it is almost time for your next scheduled dose, skip the missed dose. Do not take extra medicine to compensate for 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 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.

Other drugs may interact with acetaminophen and caffeine, including prescription and over-the-counter medicines, vitamins, and herbal products. Inform all of your health care providers about every medicine you are currently using and any medicine you begin or stop using.