MigraTen contains a combination of acetaminophen, caffeine, and isometheptene. Acetaminophen is a pain reliever and a fever reducer. Caffeine is a stimulant that causes narrowing of blood vessels (vasoconstriction). Isometheptene also causes narrowing of blood vessels. This is important in the treatment of headaches.

MigraTen is used to treat migraine headaches or severe tension headaches.

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

Tell your doctor if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You may not be able to take medicine that contains acetaminophen.

Do not take more MigraTen than is recommended. An overdose of acetaminophen can damage your liver or cause death.

Do not use MigraTen if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects. Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen.

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.

Take MigraTen exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Do not take more of MigraTen than is recommended. An overdose of acetaminophen can damage your liver or cause death.

To treat migraine headache pain:

• Take the first dose of MigraTen as soon as you notice headache symptoms, or after an attack has already begun.

• If your headache does not completely go away, take 1 tablet or capsule every hour until you feel relief.

• Do not take more than a total of 5 tablets or capsules in any 12-hour period to treat a migraine.

• If you still have migraine symptoms after taking a total of 5 tablets or capsules, call your doctor.

Store MigraTen at room temperature away from moisture and heat.

To treat tension headache pain:

• Take the first dose of MigraTen as soon as you notice tension headache symptoms.

• If your headache does not completely go away, take 1 tablet or capsule every 4 hours until you feel relief.

• Do not take more than a total of 8 tablets or capsules in any 24-hour period to treat a tension headache.

• If you still have tension headache pain after taking a total of 8 tablets or capsules, call your doctor.

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 MigraTen.

Tell your doctor if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You may not be able to take medicine that contains acetaminophen. Do not use MigraTen if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

You should not take MigraTen if you are allergic to acetaminophen (Tylenol), caffeine, or isometheptene, or if you have:

• glaucoma;

• severe kidney disease;

• severe liver disease (especially cirrhosis);

• severe or uncontrolled high blood pressure; or

• heart disease.

To make sure you can safely take MigraTen, tell your doctor if you have any of these other conditions:

• kidney or liver disease;

• a history of alcoholism;

• high blood pressure;

• blood circulation problems; or

• if you have recently had a heart attack.

FDA pregnancy category C. It is not known whether MigraTen will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. This medication can pass into breast milk and may harm a nursing baby. Do not use MigraTen without telling your doctor if you are breast-feeding a baby.

Since MigraTen 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 MigraTen can be fatal.

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.

Avoid drinking alcohol. Alcohol may increase your risk of liver damage while taking acetaminophen. Avoid coffee, tea cola, diet pills, energy drinks or other sources of caffeine while taking MigraTen. They can add to the side effects of the caffeine in the medication. 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.

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

Stop using MigraTen and call your doctor at once if you have a serious side effect such as:

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

• dark urine, clay-colored stools; or

• jaundice (yellowing of the skin or eyes).

Less serious MigraTen side effects may include:

• dizziness;

• mild skin rash;

• 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.

There may be other drugs that can interact with MigraTen. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.