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Isometheptene-dichloral-apap Oral Recall
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Questions & Answers
Side Effects & Adverse Reactions
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Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
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
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.
Sources
Isometheptene-dichloral-apap Oral Manufacturers
- Avkare, Inc.
Isometheptene-dichloral-apap Oral | Avkare, Inc.
Do not exceed the recommended dosage because severe liver damage may occur.
Tell your doctor about all usage of pain relievers.
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.
- Avkare, Inc.
Isometheptene-dichloral-apap Oral | Harris Teeter, Llc
• adults 18 years of age and older • this product is to be used once a day (every 24 hours), every day for 14 days • it may take 1 to 4 days for full effect, although some people get complete relief of symptoms within 24 hours14-Day Course of Treatment
• swallow 1 capsule with a glass of water before eating in the morning • take every day for 14 days • do not take more than 1 capsule a day • swallow whole. Do not crush or chew capsules. • do not use for more than 14 days unless directed by your doctorRepeated 14-Day Courses (if needed)
• you may repeat a 14-day course every 4 months • do not take for more than 14 days or more often than every 4 months unless directed by a doctor • children under 18 years of age: ask a doctor before use. Heartburn in children may sometimes be caused by a serious condition. Other information • read the directions, warnings and package insert before use • keep the carton and package insert. They contain important information. • store at 20-25°C (68-77°F) • keep product out of high heat and humidity • protect product from moisture - Method Pharmaceuticals, Inc.
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