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Nodolor (Isometheptene Mucate / Dichloralphenazone / Acetaminophen) - Indications and Dosage

 
 



INDICATIONS AND USAGE

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.

DOSAGE AND ADMINISTRATION

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.

HOW SUPPLIED

Red capsules imprinted with 617 in bottles of 100ct, NDC 44183-442-01.

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

Dispense in a tight, light-resistant container (USP/NF) with a child-resistant closure.

Keep out of reach of children.

All prescription substitutions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product.

Rx only

Manufactured for:
Macoven Pharmaceuticals, LLC
Magnolia, TX 77354

Rev. 04-2013

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