Country: United States
Language: English
Source: NLM (National Library of Medicine)
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)
Bryant Ranch Prepack
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. Sodium Fluoride Chewable Tablets were developed to provide systemic fluoride for use as a supplement in pediatric patients from age 3 years to age 16 years and older living in areas where the drinking water fluoride contents does not exceed 0.6 ppm F¯. Fluoride 1.0 mg Tablets are contraindicated when the fluoride content of drinking water is >0.3 ppm F¯ and should not be administered to pediatric patients under 6 years. Fluoride 0.5 mg Tablets 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 age 6 when the fluoride content of drinking water is 0.3 ppm F¯ or more or to pediatric patients under age 3 years. Fluoride 0.25 mg Tablets are co
Each tablet contains 0.25 mg Fluoride from 0.55 mg Sodium Fluoride. White to off-white, orange flavor, round-shaped chewable tablet. Debossed with "M160" on one side. NDC 63629-1130-1 (120 count).
unapproved drug other
SODIUM FLUORIDE CHEWABLE- SODIUM FLUORIDE TABLET BRYANT RANCH PREPACK _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._ ---------- SODIUM FLUORIDE CHEWABLE TABLETS SODIUM FLUORIDE CHEWABLE TABLETS THIS INSERT IS FOR 1.0 MG STRENGTH TABLETS, 0.5 MG STRENGTH TABLETS, AND 0.25 MG STRENGTH TABLETS. RX ONLY This product is a prescription product for the clinical dietary management of the metabolic processes of caries prophylaxis. WATER F¯ CONTENT AGES 0 PPM F¯ TO <0.3 PPM F¯ 0.3 PPM F¯ TO 0.6PPM F¯ >0.6PPM F¯ 3 yrs. to 6 yrs. 0.5mg* 0.25mg* 0 >6yrs. to 16 yrs. 1.0mg* 0.5mg* 0 * Per day ACTIVE INGREDIENT: Fluoride (as Sodium Fluoride) 0.25 mg / 0.5 mg / 1.0 mg INACTIVE INGREDIENTS: citric acid, magnesium stearate, malic acid, microcrystalline cellulose, orange flavor, sucralose, talc, xylitol. CAUTION: Do not eat or drink dairy products within one hour of fluoride administration. Incompatibility of fluoride with dairy foods has been reported due to formation of calcium fluoride which is poorly absorbed. 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. Sodium Fluoride Chewable Tablets were developed to provide systemic fluoride for use as a supplement in pediatric patients from age 3 years to age 16 years and older living in areas where the drinking water fluoride contents does not exceed 0.6 ppm F¯. CONTRAINDICATIONS Fluoride 1.0 mg Tablets are contraindicated when the fluoride content Read the complete document