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Isometheptene Mucate/dichloralphenazone/acetaminophen Recall
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Side Effects & Adverse Reactions
There is currently no warning information available for this product. We apologize for any inconvenience.
Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
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FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
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.
History
There is currently no drug history available for this drug.
Other Information
Taken orally, each capsule contains Isometheptene Mucate USP, 65 mg, Dichloralphenazone USP, 100 mg, and Acetaminophen USP, 325 mg. Each capsule also contains Citric Acid, FD&C Blue #1, FD&C Red #40, Gelatin, Magnesium Stearate, Microcrystalline Cellulose, Povidone, Pregelatinized Starch, Silicon Dioxide, Sodium Starch Glycolate, Stearic Acid, Talc, and Titanium Dioxide.
Isometheptene Mucate is a white crystalline powder having a characteristic aromatic odor and bitter taste. It is an unsaturated aliphatic amine with sympathomimetic properties. Isometheptene Mucate is a sympathomimetic amine and its chemical name is 6-Methylamino-2-methylheptene, tetrahydroxyadipic acid. Isometheptene Mucate has the following structural formula.
Dichloralphenazone is a white, microcrystalline powder, with slight odor and tastes saline at first, becoming acrid. Dichloralphenazone is a sedative and its chemical name is 1,2-Dihydro-1,5-dimethyl-2-phenyl-3H-pyrazol-3-one, compound with 2,2,2-trichloro-1, 1-ethanediol (1:2). Dichloralphenazone has the following structural formula.
Acetaminophen, a non-salicylate, occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Acetaminophen is an analgesic and antipyretic and its chemical name is N-(4-hydroxyphenyl)-. It has the following structural formula:
Sources
Isometheptene Mucate/dichloralphenazone/acetaminophen Manufacturers
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Eci Pharmaceuticals Llc
Isometheptene Mucate/dichloralphenazone/acetaminophen | Eci Pharmaceuticals Llc
Take this medication by mouth with or without food as directed by your doctor.
FOR RELIEF OF MIGRAINE HEADACHEThe usual adult dosage is two capsules at the first sign of the headache as directed by your doctor, followed by one capsule every hour until relieved, up to 5 capsules within a twelve hour period.
FOR RELIEF OF TENSION HEADACHEThe usual adult dosage is one or two capsules every four hours up to 8 capsules a day.
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