Isometheptene-dichloral-apap Oral Recall
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For relief of tension and vascular headaches.
|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.|
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Each red capsule contains:
Isometheptene Mucate, USP 65 mg
Dichloralphenazone, USP 100 mg
Acetaminophen, USP 325 mg
Isometheptene Mucate is a white crystalline powder having a characteristic aromatic odor and bitter taste. It is an unsaturated aliphatic amine with sympathomimetic properties. Its molecular weight is 492.65 and it has the following structural formula:
Acetaminophen, a non-salicylate, occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Its molecular weight is 151.16 and it has the following structural formula:
Dichloralphenazone is a white, microcrystalline powder, with slight odor and tastes saline at first, becoming acrid. It is a mild sedative. Its molecular weight is 519.07 and it has the following structural formula:
The inactive ingredients are: FD&C Blue #1, Gelatin, Magnesium Stearate, FD&C Red #40, Colloidal Silicon Dioxide, Talc, Titanium Dioxide.