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Drug Information For:
Ingredient Name:ISOMETHEPTENE (eye-soe-metyh-EP-teen), DICHLORALPHENAZONE (dye-klor-al-FEN-a-zone), and ACETAMINOPHEN (a-seat-a-MIN-oh-fen)
Common Uses:This medicine is an analgesic, vasoconstrictor, and sedative combination used to treat migraine and tension headaches.
Before Using This Medicine:WARNING: THIS MEDICINE CONTAINS ACETAMINOPHEN. Severe and sometimes fatal liver problems, including the need for liver transplant, have been reported with the use of acetaminophen. Most cases of these liver problems occurred in patients taking excessive doses of acetaminophen (more than 4,000 mg per day). Also, patients who developed these liver problems were often using more than 1 medicine that contained acetaminophen. Discuss any questions or concerns with your doctor. Some medicines or medical conditions may interact with this medicine. INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. DO NOT TAKE THIS MEDICINE if you are also taking furazolidone or monoamine oxidase inhibitors (MAOIs). ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking anticoagulants, bromocriptine, guanadrel, guanethidine, tricyclic antidepressants, or isoniazid. Inform your doctor of any other medical conditions, allergies, pregnancy, or breast-feeding. USE OF THIS MEDICINE IS NOT RECOMMENDED if you have a history of high blood pressure or heart or kidney conditions. Contact your doctor or pharmacist if you have any questions or concerns about using this medicine.
How to Use This Medicine:Follow the directions for using this medicine provided by your doctor. STORE THIS MEDICINE at room temperature, away from heat and light. IF YOU MISS A DOSE OF THIS MEDICINE, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Cautions:DO NOT DRIVE, OPERATE MACHINERY, OR DO ANYTHING ELSE THAT COULD BE DANGEROUS until you know how you react to this medicine. Using this medicine alone, with other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks. DO NOT TAKE MORE THAN 5 CAPSULES IN 12 HOURS or more than 8 capsules in 24 hours, unless directed otherwise by your doctor. THIS MEDICINE CONTAINS ACETAMINOPHEN. Do not take additional acetaminophen for pain or fever without checking with your doctor or pharmacist. Ask your pharmacist if you have questions about which medicines contain acetaminophen. ALCOHOL WARNING: If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/fever reducers. Acetaminophen may cause liver damage. BEFORE YOU BEGIN TAKING ANY NEW MEDICINE, either prescription or over-the-counter, check with your doctor or pharmacist.
Possible Side Effects:A SIDE EFFECT, that may go away during treatment, is dizziness. If it continues or is bothersome, check with your doctor. 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. CHECK WITH YOUR DOCTOR AS SOON AS POSSIBLE if you experience dark urine or pale stools, right-sided stomach pain or tenderness, unusual fatigue, or yellowing of the skin or eyes. AN ALLERGIC REACTION to this medicine is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash; hives; difficulty breathing; tightness in the chest; or swelling of the mouth, face, lips, or tongue. This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your healthcare provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Overdose:If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include vomiting, excessive sweating, dark urine, stomach pain, and extreme fatigue.
Additional Information:DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. DO NOT USE THIS MEDICINE for other health conditions. KEEP THIS MEDICINE out of the reach of children. IF USING THIS MEDICINE FOR AN EXTENDED PERIOD OF TIME, obtain refills before your supply runs out.
Copyright 2014 Wolters Kluwer Health, Inc.