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|Acetaminophen/Caffeine/Isometheptene

Acetaminophen/Caffeine/Isometheptene

Acetaminophen/Caffeine/Isometheptene is used for:

Treating certain types of headaches (tension, vascular). It may also be used to treat migraine headaches or for other conditions as determined by your doctor.

Acetaminophen/Caffeine/Isometheptene is a combination analgesic, xanthene derivative, and sympathomimetic. It works by decreasing pain and narrowing the blood vessels in the head and brain.

Do NOT use Acetaminophen/Caffeine/Isometheptene if:

• you are allergic to any ingredient in Acetaminophen/Caffeine/Isometheptene
• you have glaucoma, severe kidney problems, high blood pressure, heart problems, or liver problems
• you are taking droxidopa or have taken furazolidone or a monoamine oxidase (MAO) inhibitor (eg, phenelzine) within the past 14 days

Contact your doctor or health care provider right away if any of these apply to you.

Before using Acetaminophen/Caffeine/Isometheptene :

Some medical conditions may interact with Acetaminophen/Caffeine/Isometheptene . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have alcoholism or if you consume 3 or more alcohol-containing drinks every day
• if you have liver or kidney problems, hepatitis, high blood pressure, heart problems, blood vessel problems, or the blood disease porphyria
• if you have had a recent heart attack
• if you have anxiety or trouble sleeping

Some MEDICINES MAY INTERACT with Acetaminophen/Caffeine/Isometheptene . Tell your health care provider if you are taking any other medicines, especially any of the following:

• Catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), quinolones (eg, ciprofloxacin), or tricyclic antidepressants (eg, amitriptyline) because the side effects of Acetaminophen/Caffeine/Isometheptene may be increased
• Droxidopa because the risk of severe heart problems, including irregular heartbeat or heart attack, may be increased
• Furazolidone or MAO inhibitors (eg, phenelzine) because the risk of severe side effects, such as severe headache, high blood pressure, or high fever, may be increased
• Isoniazid or other medicines that may harm the liver (eg, methotrexate, ketoconazole) because the risk of side effects on the liver may be increased. Talk with your doctor if you are unsure if any of your medicines may harm the liver.
• Anticoagulants (eg, warfarin), bromocriptine, or theophylline because the side effects may be increased by Acetaminophen/Caffeine/Isometheptene
• Guanadrel or guanethidine because their effectiveness may be decreased by Acetaminophen/Caffeine/Isometheptene

This may not be a complete list of all interactions that may occur. Ask your health care provider if Acetaminophen/Caffeine/Isometheptene may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Acetaminophen/Caffeine/Isometheptene :

Use Acetaminophen/Caffeine/Isometheptene as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Acetaminophen/Caffeine/Isometheptene may be taken with or without food.
• For a migraine headache - Take Acetaminophen/Caffeine/Isometheptene at the first sign of a headache. If the initial dose does not relieve your headache, additional doses may be needed according to your doctor"s instructions. Do not take a dose of Acetaminophen/Caffeine/Isometheptene within 60 minutes of your last dose. Do not take more than 5 capsules within a 12-hour period.
• For a tension headache - Do not take more than 8 capsules within a 24-hour period.
• If you miss a dose of Acetaminophen/Caffeine/Isometheptene and you still have a headache, take it as soon as you remember. If you need to take additional doses, continue to follow your doctor"s dosing instructions. Do not take Acetaminophen/Caffeine/Isometheptene more often than directed. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Acetaminophen/Caffeine/Isometheptene .

Important safety information:

• Acetaminophen/Caffeine/Isometheptene may cause dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Acetaminophen/Caffeine/Isometheptene . Using Acetaminophen/Caffeine/Isometheptene alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
• Acetaminophen/Caffeine/Isometheptene contains acetaminophen. Before you begin taking any new prescription or over-the-counter medicine, read the ingredients to see if it also contains acetaminophen. If it does or if you are uncertain, contact your doctor or pharmacist.
• If you consume 3 or more alcohol-containing drinks every day, ask your doctor whether you should take Acetaminophen/Caffeine/Isometheptene or other pain relievers/fever reducers. Acetaminophen may cause liver damage. Alcohol use combined with Acetaminophen/Caffeine/Isometheptene may increase your risk for liver damage.
• Use Acetaminophen/Caffeine/Isometheptene with extreme caution in CHILDREN. Safety and effectiveness have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Acetaminophen/Caffeine/Isometheptene during pregnancy. Acetaminophen/Caffeine/Isometheptene is excreted in breast milk. If you are or will be breast-feeding while you are using Acetaminophen/Caffeine/Isometheptene , check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Acetaminophen/Caffeine/Isometheptene :

All medicines may cause side effects, but many people have no, or minor, side effects. If any of the following most COMMON side effects continue or become bothersome, check with your doctor: Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Temporary dizziness.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); dark urine or pale stools; right-sided abdominal pain or tenderness; unusual fatigue; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include bloody vomit; dark urine; excessive sweating; extreme fatigue; irregular heartbeat; nausea and vomiting; stomach pain.

Store Acetaminophen/Caffeine/Isometheptene at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Acetaminophen/Caffeine/Isometheptene out of the reach of children and away from pets.

General information:

• If you have any questions about Acetaminophen/Caffeine/Isometheptene , please talk with your doctor, pharmacist, or other health care provider.
• Acetaminophen/Caffeine/Isometheptene is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Acetaminophen/Caffeine/Isometheptene . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.