(isometheptene mucate, dichloralphenazone and acetaminophen)
Each red capsule contains Isometheptene Mucate USP, 65 mg, Dichloralphenazone USP, 100 mg, and 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.
Acetaminophen, a non-salicylate, occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste.
Midrin (acetaminophen, isometheptene and dichloralphenazone) capsules contain FD&C Yellow No. 6 as a color additive.
What are the possible side effects of acetaminophen, dichloralphenazone, and isometheptene (Epidrin, Midrin, Migquin, Migragesic IDA)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using the medicine and call your doctor at once if you have a serious side effect such as:
- low fever with nausea, stomach pain, and loss of appetite;
- dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
- fast or uneven heart rate;
- easy bruising or bleeding, unusual weakness;...
*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/a
Transient dizziness and skin rash may appear in hypersensitive patients. This can usually be eliminated by reducing the dose.
No information provided.
No information provided.
Midrin® (acetaminophen, isometheptene and dichloralphenazone) is contraindicated in glaucoma and/or severe cases of renal disease, hypertension, organic heart disease, hepatic disease and in those patients who are on monoamine-oxidase (MAO) inhibitor therapy.
Isometheptene Mucate, a sympathomimetic amine, acts by constricting dilated cranial and cerebral arterioles, thus reducing the stimuli that lead to vascular headaches. Dichloralphenazone, a mild sedative, reduces the patient's emotional reaction to the pain of both vascular and tension headaches. Acetaminophen raises the threshold to painful stimuli, thus exerting an analgesic effect against all types of headaches.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.