ReNaf Fluoride Chewable Tablets
Generic name: sodium fluoride
Dosage form: tablet, chewable
Drug class:Minerals and electrolytes
Medically reviewed by Drugs.com. Last updated on Oct 22, 2021.
Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
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DESCRIPTION:
Each ReNaf Fluoride Chewable Tablet is sugar free and erythrosine (FD&C Red Dye No.3) free. Each ReNaf Fluoride Chewable Tablets 1 mg contain 1 mg fluoride ion (F-) from 2.2 mg sodium fluoride (NaF). Each ReNaf Fluoride Chewable Tablets 0.5 mg contains 0.5 mg F- from 1.1 mg NaF. Each ReNaf Fluoride Chewable Tablets 0.25 mg contains 0.25mg F- from 0.55 mg NaF.CLINICAL PHARMACOLOGY:
Sodium fluoride acts systemically and topically by increasing tooth resistance to cavities and acid dissolution, by promoting remineralization.
INDICATIONS AND USAGE:
ReNaf Fluoride Chewable Tablets 1.0 mg, 0.5 mg, 0.25 mg are to be used as a dental caries preventive in children. Ingestion of fluoridated drinking water (1 ppm F-) during the period of tooth development results in a significant decrease in the incidence of dental caries. ReNaf Fluoride Chewable Tablets were developed to provide systemic fluoride for use as a once daily supplement in children from 6 months to age 3 years and older living in areas where the drinking water fluoride content does not exceed 0.6 ppm F-.
CONTRAINDICATIONS:
ReNaf Fluoride Chewable Tablets 1.0 mg are contraindicated when the fluoride content of drinking water is 0.3 ppm F- or more and should not be administered to children under age 6 years. ReNaf Fluoride Chewable Tablets 0.5 mg are contraindicated when the fluoride content of drinking water is more than 0.6 ppm F- and should not be administered to children underage 6 when the fluoride content of drinking water is 0.3 ppm F- or more or to children under age 3 years. ReNaf Fluoride Chewable Tablets 0.25 mg are contraindicated when the fluoride content of drinking water is more than 0.6 ppm F- and should not be administered to children under age 3 years when the fluoride content of drinking water is 0.3 ppm F- or more. Do not administer any strength of ReNaf Fluoride Chewable Tablets to children under age 6 months. ReNaf Fluoride Chewable Tablets are not indicated for use in adults.
