Acetaminophen, caffeine, and isometheptene

Name: Acetaminophen, caffeine, and isometheptene

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.

Acetaminophen, caffeine, and isometheptene dosing information

Usual Adult Dose for Headache:

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

Tension headache: 1 to 2 capsules or caplets every 4 hours, up to 8 capsules or caplets a day

For the Consumer

Applies to acetaminophen / caffeine / isometheptene mucate: oral capsule, oral tablet

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
  • Not able to pass urine or change in how much urine is passed.
  • Feeling confused.
  • A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Dizziness.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Usual Adult Dose for Headache

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

Tension headache: 1 to 2 capsules or caplets every 4 hours, up to 8 capsules or caplets a day

Precautions

Contraindicated in patients with severe renal or hepatic dysfunction.

Patients who consume three or more alcohol containing drinks per day should be informed to consult with their physician for advice on when and how to take acetaminophen. Chronic, heavy alcohol users may be at increased risk of liver damage when taking more than recommended dosages.

Caffeine is a central nervous system stimulant and in cases of caffeine overdose, seizures have been reported.

Safety and effectiveness have not been established in pediatric patients (less than 18 years of age).

Acetaminophen / caffeine / isometheptene mucate Breastfeeding Warnings

One small study on acetaminophen has reported that following a 1000 mg dose of acetaminophen to nursing mothers, nursing infants receive less than 1.85% of the weight-adjusted maternal oral dose.

Acetaminophen is excreted into human milk in small concentrations. One case of a rash has been reported in a nursing infant. Acetaminophen is considered compatible with breast-feeding by the American Academy of Pediatrics. Caffeine is excreted into human milk in small amounts. Adverse effects in the nursing infant are unlikely. However, irritability and poor sleep patterns have been reported in nursing infants. The amount of caffeine generally found in caffeinated beverages is considered to usually be compatible with breast-feeding by the American Academy of Pediatrics. Because caffeine is excreted into human milk and because caffeine is metabolized slowly by nursing infants, consumption of more than moderate levels of caffeine by nursing mothers is not recommended. There are no data on the excretion of isometheptene into human milk.

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