"March 11, 2014 - The U.S. Food and Drug Administration allowed marketing of the first device as a preventative treatment for migraine headaches. This is also the first transcutaneous electrical nerve stimulation (TENS) device specifically "...
*Based on a review of this drug (isometheptene mucate) by the National Academy of Sciences-National Research Council and/or other information, FDA has classified the other indication as "possibly" effective in the treatment of migraine headache. Final classification of the less-than-effective indication requires further investigation.
DOSAGE AND ADMINISTRATION
FOR RELIEF OF MIGRAINE HEADACHE: The usual adult dosage is two capsules at once, followed by one capsule every hour until relieved, up to 5 capsules within a twelve hour period.
FOR RELIEF OF TENSION HEADACHE: The usual adult dosage is one or two capsules every four hours up to 8 capsules a day.
Red capsules imprinted with the word MIDRIN (acetaminophen, isometheptene and dichloralphenazone) in pink letters. Bottles of 100 capsules, NDC 14508-304-08. Store at controlled room temperature 15°-30°C (59°-86° F) in a dry place.
Manufactured and distributed by: CARACO PHARMACEUTICAL LABORATORIES, LTD. DETROIT, MI 48202 Under license from: Sun Pharmaceutical Industries. FDA Rev date: n/aThis monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 6/26/2008
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