Data from FDA - Curated by Toby Galbraith - Last updated 28 July 2017
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.
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.
|Agency product number||X66NSO3N35|
|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.|