FDA records indicate that there are no current recalls for this drug.
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Side Effects & Adverse Reactions
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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
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:
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 519.03 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:
Acetaminophen raises the threshold of painful stimuli, thus exerting an analgesic affect against certain types of headaches.
The inactive ingredients are: Colloidal Silicon Dioxide, FD&C Blue #1, FD&C Red #40, Gelatin, Magnesium Stearate, Microcrystalline Cellulose and Titanium Dioxide.
Sources
Nodolor Manufacturers
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Macoven Pharmaceuticals
Nodolor | Macoven Pharmaceuticals
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 HEADACHEThe 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 HEADACHEThe usual adult dosage is one or two capsules every four hours up to 8 capsules a day.
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