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This combination medication is used to relieve tension and migraine headaches. Headache pain can sometimes be caused by widened blood vessels in the head. Isometheptene works by narrowing these widened blood vessels. Caffeine also works by narrowing widened blood vessels in the head, and is a mild stimulant. Acetaminophen relieves mild to moderate pain from various causes, including headache.
See also Warning section.
Take this medication by mouth with or without food as directed by your doctor. The dosage is based on your medical condition and response to treatment.
For migraine headache, take this medication at the first sign of a migraine as directed by your doctor, usually 1 to 2 tablets first, followed by 1 tablet every hour until the headache is relieved. Do not take more than 5 tablets in a 12-hour period.
For tension headache, take as directed by your doctor, usually every 4 hours as needed. Do not take more than 8 tablets in a 24-hour period.
Pain medications work best if they are used as the first signs of pain occur. If you wait until the pain has worsened, the medication may not work as well.
If you are using drugs for migraine attacks on 10 or more days each month, the drugs may actually make your headaches worse (medication overuse headache). Do not use medications more often or for longer than directed. Tell your doctor if you need to use this medication more often, or if the medication is not working as well, or if your headaches get worse.
See also Warning section.
Dizziness, trouble sleeping, nervousness, or nausea may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
See also Warning section.
Before taking this medication, tell your doctor or pharmacist if you are allergic to isometheptene, acetaminophen, or caffeine; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood circulation problems (for example, in your legs, arms/hands), high blood pressure, glaucoma, heart problems (such as chest pain, previous heart attack), kidney disease, liver disease, stroke or "mini-stroke" (transient ischemic attack), use/abuse of alcohol.
This drug may make you dizzy. Alcohol or marijuana can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana.
Before having surgery or certain medical procedures (such as a heart stress test or a procedure to restore a normal heart rhythm if you have an unusually fast heartbeat), tell your doctor or dentist that you use this medication and about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.
Acetaminophen and caffeine pass into breast milk. It is unknown if isometheptene passes into breast milk. Consult your doctor before breast-feeding.
Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
See also Warning section.
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
A product that may interact with this drug is: ketoconazole.
Taking MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Do not take any MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, safinamide, selegiline, tranylcypromine) during treatment with this medication. Most MAO inhibitors should also not be taken for two weeks before and after treatment with this medication. Ask your doctor when to start or stop taking this medication.
This medication may interfere with certain medical/laboratory tests (including urine catecholamine/5-HIAA levels, dipyridamole-thallium imaging), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.
If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: nausea, vomiting, loss of appetite, sweating, stomach/abdominal pain, extreme tiredness, yellowing eyes/skin, dark urine, irregular heartbeat.
Do not share this medication with others.
Laboratory and/or medical tests (such as liver function tests) may be performed periodically to check for side effects. Consult your doctor for more details.
Certain foods/beverages or food additives (such as red wine, cheese, chocolate, monosodium glutamate) as well as lifestyle patterns such as irregular eating/sleeping habits or stress may bring on a migraine headache. Avoiding these "triggers" may help lessen migraine attacks. Consult your doctor for more details.
Selected from the Licensed Solutions data included with permission and copyrighted by FDB, inc., 2014. This copyrighted material has been downloaded and Licensed data provider and is not for distribution in professional healthcare settings. This information is generalized and not intended as specific medical advice. Consult your healthcare professional before taking any drug or commencing or discontinuing any course of treatment.