Data from FDA - Curated by Toby Galbraith - Last updated 28 July 2017

Indication(s)

Directions USE AS DIRECTED BY YOUR PHYSICIAN.

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Advisory information

Special warnings and precautions
Caution Do not use this product if you are allergic to any of the ingredients. Take this product at least 2 hours before or after taking any products containing calcium (including milk, yogurt, other dairy products) or aluminum/magnesium hydroxide (e.g., certain antacids/laxatives). Prolonged daily ingestion of excessive fluoride may result in varying degrees of dental fluorosis. Account for all daily sources of fluoride intake.

Usage information

Dosing and administration
This medical food product is formulated to be administered orally, under the ongoing supervision of a physician and is intended for the dietary management of dental caries for which a distinctive nutritional requirement of fluoride, based on recognized scientific principles, has been established by medical evaluation.

More information

Category Value
Agency product number X66NSO3N35
Orphan designation No
Product NDC 44946-1021
Date Last Revised 05-06-2017
Type HUMAN PRESCRIPTION DRUG
List of excipients Other Ingredients Xylitol, microcrystalline cellulose, mannitol, talc, magnesium stearate, sucralose, natural fruit flavor, citric acid.
Storage and handling Storage Store in a cool, dry place at room temperature 20° - 25°C (68° - 77°F) away from heat and sunlight. Store in original container.
Marketing authorisation holder Sancilio & Company Inc.