IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

ISOMETHEPTENE/ACETAMINOPHEN/DICHLORALPHENAZONE - ORAL

(EYE-soe-meth-EP-teen/a-SEET-a-MIN-oh-fen/ DYE-klor-al-FEN-a-zone)

COMMON BRAND NAME(S): Amidrine, Isocom, Midchlor, Midrin

WARNING: One ingredient in this product is acetaminophen. Taking too much acetaminophen may cause serious (possibly fatal) liver disease. Adults should not take more than 4000 milligrams (4 grams) of acetaminophen a day. If you have liver problems, consult your doctor or pharmacist for a safe dosage of this medication. Daily use of alcohol, especially when combined with acetaminophen, may increase your risk for liver damage. Avoid alcohol. Check with your doctor or pharmacist for more information. Get medical help right away if you have any symptoms of liver damage, including: dark urine, persistent nausea/vomiting, stomach/abdominal pain, extreme tiredness, or yellowing eyes/skin.

Acetaminophen is an ingredient found in many nonprescription products and in some combination prescription medications (such as pain/fever drugs or cough-and-cold products). Carefully check the labels on all your medicines because they may also contain acetaminophen. Ask your pharmacist about using those products safely. Get medical help right away if you have taken more than 4000 milligrams of acetaminophen a day, even if you feel well.

USES: This combination medication is used to relieve tension and migraine headaches. Acetaminophen helps to decrease the pain from the headache. Isometheptene helps to narrow the widened blood vessels in the head. Headache pain can be caused by these widened blood vessels. Dichloralphenazone helps to relax the body.

HOW TO USE: See also Warning section.

Take this medication by mouth with or without food as directed by your doctor.

Dosage is based on your medical condition and response to therapy.

For migraine headaches, take at the first sign of the headache as directed by your doctor. Then you will usually take 1 capsule every hour as needed until the headache is relieved, or take as directed by your doctor. Do not take more than 5 capsules in a 12-hour period.

For tension headaches, take every 4 hours as needed or as directed by your doctor. Do not take more than 8 capsules in a 24-hour period.

This medication may cause withdrawal reactions, especially if it has been used regularly for a long time (longer than 2 weeks) or in high doses. In such cases, withdrawal symptoms (such as mental/mood changes, shaking, seizures) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions immediately.

Though it is very unlikely to occur, this medication can also result in abnormal drug-seeking behavior (addiction/habit forming). Do not increase your dose, take it more frequently, or use it for a longer time than prescribed. Properly stop the medication when so directed. This will lessen the chances of becoming addicted.

Inform your doctor if you notice increased use of this medication, the medication not working as well, a worsening of headaches, an increase in the number of headaches, or use of this medication for more than 2 headache episodes a week. Your doctor may need to change your medication and/or add a separate medication to prevent the headaches.