Acetaminophen, dichloralphenazone, and isometheptene

Name: Acetaminophen, dichloralphenazone, and isometheptene

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

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.

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 medicine if you are allergic to acetaminophen (Tylenol), dichloralphenazone, isometheptene, or chloral hydrate (Somnote), or if you have:

  • liver disease;

  • severe kidney disease;

  • glaucoma;

  • peripheral vascular disease such as Raynaud's syndrome;

  • high blood pressure, heart disease, coronary artery disease, blood circulation problems; or

  • if you have recently had a stroke or heart attack.

To make sure acetaminophen, dichloralphenazone, and isometheptene is safe for you, tell your doctor if you have a history of kidney disease.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

Acetaminophen, dichloralphenazone, and isometheptene 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 medication than is recommended. An overdose of acetaminophen can damage your liver or cause death.

You may take this medication with or without food.

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.

This medication can cause unusual results with certain medical tests. 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 should I avoid while taking this medicine?

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.

This medicine side effects

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 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:

  • severe drowsiness or restless feeling, feeling like you might pass out;

  • fast, slow, or uneven heart rate;

  • rapid breathing, weak or shallow breathing;

  • little or no urinating;

  • cold feeling; or

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

Common side effects may include:

  • dizziness, drowsiness; or

  • upset stomach.

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?

Taking this medicine with other drugs that make you sleepy or slow your breathing can worsen these effects. Ask your doctor before taking acetaminophen, dichloralphenazone, and isometheptene with a sleeping pill (especially sodium oxybate), narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, mental illness, or seizures.

Other drugs may interact with acetaminophen, dichloralphenazone, 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.

Usual Adult Dose for Headache

Migraine Headache: 2 capsules at once orally, followed by one capsule every hour until relieved, up to 5 capsules within a 12 hour period

Tension Headache: 1 to 2 capsules every 4 hours, up to 8 capsules a day