CAUTION

Federal law prohibits dispensing without prescription.

Each red capsule with pink band contains Isometheptene Mucate 65 mg., Dichloralphenazone 100 mg., and Acetaminophen 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.

Dichloralphenazone is a white, microcrystalline powder, with slight odor and tastes saline at first, becoming acrid. It is a mild sedative.

Acetaminophen, a non-salicylate, occurs as a white, odorless, crystalline powder possessing a slightly bitter taste.

Midrin® capsules contain FD&C Yellow No. 6 as a color additive.

ACTIONS

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' 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.

INDICATIONS

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.

CONTRAINDICATIONS

Midrin® 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.

PRECAUTIONS

Caution should be observed in hypertension, peripheral vascular disease and after recent cardiovascular attacks.

ADVERSE REACTIONS

Transient dizziness and skin rash may appear in hypersensitive patients. This can usually be eliminated by reducing the dose.

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.

HOW SUPPLIED

Red capsules imprinted with pink band, the letter "C" and 86120. Bottles of 50 capsules, NDC 0086-0120-05. Bottles of 100 capsules, NDC 0086-0120-10. Bottles of 250 capsules, NDC 0086-0120-25. Store at controlled room temperature 15°-30°C (59°-86°F) in a dry place.

The most recent revision of this labeling is July 1997.

Manufactured for Carnrick Laboratories

PRODUCT PHOTO(S):

NOTE: These photos can be used only for identification by shape, color, and imprint. They do not depict actual or relative size.

The product samples shown here have been supplied by the manufacturer and reproduced in full color by PDR as a quick-reference identification aid. While every effort has been made to assure accurate reproduction, please remember that any visual identification should be considered preliminary. In cases of poisoning or suspected overdosage, the drug' identity should be verified by chemical analysis.