acetaminophen, caffeine, and isometheptene

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Pronunciation: a SEET a MIN oh fen, KAF een, and EYE so meth EP tane

What is the most important information I should know about this medicine?

You should not use this medicine if you have liver disease, severe kidney disease, heart disease, high blood pressure, or glaucoma.

Do not use this medicine if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine.

Do not take more of this medicine 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).

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.

What is 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.

Acetaminophen, caffeine, and isometheptene is a combination medicine used to treat migraine headaches or severe tension headaches.

Acetaminophen, caffeine, and isometheptene may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking this medicine?

Do not use acetaminophen, caffeine, and isometheptene if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine.

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

  • glaucoma;
  • severe kidney disease;
  • liver disease, cirrhosis;
  • high blood pressure; or
  • heart disease.

To make sure this medicine is safe for you, tell your doctor if you have:

  • a history of alcoholism, or if you drink more than 3 alcoholic beverages per day;
  • blood circulation problems; or
  • if you have recently had a heart attack.

FDA pregnancy category C. It is not known whether acetaminophen, caffeine, and isometheptene will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

This medicine can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

How should I take this medicine?

Follow all directions on your prescription label. Do not take more of this medicine than is recommended. An overdose of acetaminophen can damage your liver or cause death.

To treat migraine headache pain:

  • Take the first dose of this medicine 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 every hour until you feel relief.
  • Do not take more than a total of 5 tablets in any 12-hour period to treat a migraine.
  • If you still have migraine symptoms after taking a total of 5 tablets, call your doctor.

To treat tension headache pain:

  • Take the first dose of this medicine as soon as you notice tension headache symptoms.
  • If your headache does not completely go away, take 1 tablet every 4 hours until you feel relief.
  • Do not take more than a total of 8 tablets in any 24-hour period to treat a tension headache.
  • If you still have tension headache pain after taking a total of 8 tablets, call your doctor.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Since this medicine 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.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of acetaminophen, caffeine, and isometheptene 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.

What should I avoid while taking this medicine?

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 this medicine. 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.

What are the possible side effects of this medicine?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult 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 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 again take any medicine that contains acetaminophen.

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

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

Common side effects may include:

  • dizziness;
  • sleep problems (insomnia); or
  • feeling anxious or restless.

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.

What other drugs will affect this medicine?

Other drugs may interact with acetaminophen, caffeine, and isometheptene, 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.

Where can I get more information?

Your pharmacist can provide more information about acetaminophen, caffeine, and isometheptene.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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