What is the most important information I should know about acetaminophen, dichloralphenazone, and isometheptene?

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

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.

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

You should not take acetaminophen, dichloralphenazone, and isometheptene if you are allergic to acetaminophen (Tylenol), dichloralphenazone, isometheptene, or chloral hydrate (Somnote), or if you have glaucoma or if you are also taking sodium oxybate (Xyrem).

Do not take more than 5 capsules in 12 hours to treat a migraine, or 8 capsules in 24 hours to treat a tension headache.

Ask a doctor or pharmacist before using any other pain, cold, allergy, 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.

Do not use acetaminophen, dichloralphenazone, and isometheptene 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.

What is acetaminophen, dichloralphenazone, and isometheptene?

Acetaminophen is a pain reliever and a fever reducer.

Dichloralphenazone is a sedative that slows the central nervous system.

Isometheptene causes narrowing of blood vessels (vasoconstriction).

The combination of acetaminophen, dichloralphenazone, and isometheptene is used to treat migraine headaches or severe tension headaches.

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

What should I discuss with my healthcare provider before taking acetaminophen, dichloralphenazone, and isometheptene?

Do not take this medicine 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.

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.

You should not take this medication if you are allergic to acetaminophen (Tylenol), dichloralphenazone, isometheptene, or chloral hydrate (Somnote), or if you have:

• glaucoma; or
• if you are also taking sodium oxybate (Xyrem).

To make sure you can safely take acetaminophen, dichloralphenazone, and isometheptene, tell your doctor if you have any of these other conditions:

• liver disease or cirrhosis;
• kidney disease;
• coronary artery disease, circulation problems;
• high blood pressure;
• stomach ulcer or problems with your esophagus;
• depression;
• a history of drug or alcohol addiction; or
• if you have recently had a stroke or heart attack.

FDA pregnancy category C. It is not known whether acetaminophen, dichloralphenazone, and isometheptene 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 this medication without telling your doctor if you are breast-feeding a baby.

How should I take acetaminophen, dichloralphenazone, and isometheptene?

Take 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 this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death.

You may take this medication with or without food.

Take the medicine with a full glass of water.

To treat migraine headache pain:

• Take the first dose of this medication as soon as you notice headache symptoms, or after an attack has already begun.
• If your headache does not completely go away, take 1 capsule every hour until you feel relief.
• Do not take more than a total of 5 capsules in any 12-hour period to treat a migraine.
• If you still have migraine symptoms after taking a total of 5 capsules, call your doctor.

To treat tension headache pain:

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

Call your doctor if this medication seems to stop working as well in relieving your pain. Also call your doctor if your headaches get worse or you have more than 2 headaches per week.

Do not stop using this medicine suddenly if you have been using it for longer than 2 weeks in a row, or you could have unpleasant withdrawal symptoms. Talk to your doctor about how to avoid withdrawal symptoms when you stop using acetaminophen, dichloralphenazone, and isometheptene.

If you need surgery, tell the surgeon ahead of time that you are using this medication.

This medication can cause unusual results with certain lab tests for glucose (sugar) in the urine. Tell any doctor who treats you that you are using acetaminophen, dichloralphenazone, and isometheptene.

Store at room temperature away from moisture, heat, and light.

What happens if I miss a dose?

Since this medicine is used as needed, it does not have a daily dosing schedule. Call your doctor promptly if your symptoms do not improve after using acetaminophen, dichloralphenazone, and isometheptene.

Do not take more than 5 capsules in 12 hours to treat a migraine, or 8 capsules in 24 hours to treat a tension headache.

What happens if I overdose?

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.

Other overdose symptoms may include severe dizziness or drowsiness, feeling restless or cold, changes in your breathing or heart rate, and fainting.

What should I avoid while taking acetaminophen, dichloralphenazone, and isometheptene?

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

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

Ask a doctor or pharmacist before using any other pain, cold, allergy, 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 acetaminophen, dichloralphenazone, and isometheptene?

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.

Stop using the medicine 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, jaundice (yellowing of the skin or eyes);
• fast or uneven heart rate;
• easy bruising or bleeding, unusual weakness; or
• fever, chills, sore throat, body aches, flu symptoms.

Less serious side effects may include:

• dizziness, drowsiness;
• mild nausea; or
• mood changes.

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 acetaminophen, dichloralphenazone, and isometheptene?

Before using this medication, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by acetaminophen, dichloralphenazone, and isometheptene.

Tell your doctor about all other medications you use, especially:

• a blood thinner such as warfarin (Coumadin, Jantoven);
• isoniazid (for treating tuberculosis); or
• an antidepressant such as amitriptyline (Elavil, Limbitrol, Vanatrip), doxepin (Sinequan), desipramine (Norpramin), imipramine (Janimine, Tofranil), nortriptyline (Pamelor), and others.

This list is not complete and other drugs may interact with acetaminophen, dichloralphenazone, and isometheptene. 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.

Where can I get more information?

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