Страна: САЩ
Език: английски
Източник: NLM (National Library of Medicine)
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)
PureTek Corporation
ORAL
PRESCRIPTION DRUG
For once daily self-applied systemic use as a dental caries preventive in pediatric patients. It has been established that 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. Fluoride Chewable Tablets were developed to provide systemic fluoride for use as a supplement in pediatric patients from 6 months to 3 years of age and older living in areas where the drinking water fluoride content does not exceed 0.6 ppm F*. 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 pediatric patients under 6 years of age when the fluoride content of drinking water is 0.3 ppm F* or to pediatric patients under age 3 years. Do not administer Fluoride Chewable Tablets (any strength) to pediatric patients under age 6 months.
Chewable tablets containing 0.5 mg fluoride are purple-colored, grape flavor, un-scored, round, debossed “105”. Available in bottles of 120’s and 1000’s. NDC:59088-105-73
unapproved drug other
FLUORIDE- SODIUM FLUORIDE TABLET, CHEWABLE PURETEK CORPORATION _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._ ---------- PRESCRIBING INFORMATION DESCRIPTION Each FLUORIDE CHEWABLE TABLET 0.5 MG is erythrosine (FD&C Red Dye No. 3) free. Each tablet contains 0.5 mg F* from 1.1 mg sodium fluoride (NaF). Each tablet for oral administration contains sodium fluoride equivalent to fluoride 0.5 mg and the following inactive ingredients: croscarmellose sodium, D&C Red No. 27 aluminum lake, FD&C Blue No. 1 aluminum lake, grape flavor, magnesium stearate, mannitol, microcrystalline cellulose, sucrose. CLINICAL PHARMACOLOGY Sodium fluoride acts systemically (before tooth eruption) and topically (post eruption) by increasing tooth resistance to acid dissolution, by promoting remineralization, and by inhibiting the cariogenic microbial process. INDICATIONS AND USAGE For once daily self-applied systemic use as a dental caries preventive in pediatric patients. It has been established that 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. Fluoride Chewable Tablets were developed to provide systemic fluoride for use as a supplement in pediatric patients from 6 months to 3 years of age and older living in areas where the drinking water fluoride content does not exceed 0.6 ppm F*. CONTRAINDICATIONS 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 pediatric patients under 6 years of age when the fluoride content of drinking water is 0.3 ppm F* or to pediatric patients under age 3 years. Do not administer Fluoride Chewable Tablets (any strength) to pediatric patients under age 6 months. WARNINGS Prolonged daily ingestion of quantities greater than the recommended amount may result in var Прочетете целия документ