Χώρα: Ηνωμένες Πολιτείες
Γλώσσα: Αγγλικά
Πηγή: NLM (National Library of Medicine)
Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O)
Sancilio & Company Inc
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 "SCI" on one side and 1006 on the other. NDC 44946-1015-2 (60 count) , NDC 44946-1015-3 (120 count), NDC 44946-1015-6 (30 count blister). Each tablet contains 0.5 mg Fluoride from 1.1 mg Sodium Fluoride. White to off-white, orange flavor, round-shaped chewable tablet. Debossed "SCI" on one side and 1007 on the other. NDC 44946-1016-7 (7 count sample size), NDC 44946-1016-2 (60 count), NDC 44946-1016-3 (120 count), NDC 44946-1016-6 (30 count blister). Each tablet contains 1.0 mg Fluoride from 2.2 mg Sodium Fluoride. White to off-white, orange flavor, round-shaped chewable tablet. Debossed "SCI" on one side and 1004 on the other. NDC 44946-1017-2 (60 count) , NDC 44946-1017-3 (120 count), NDC 44946-1017-6 (30 count blister). Store at 25° C (77° F); excursions permitted to 15° - 30° C (59° - 86° F). See USP Controlled Room Temperature. Protect from light and moisture.
unapproved drug other
LUDENT- SODIUM FLUORIDE TABLET, CHEWABLE SANCILIO & COMPANY INC _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 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. 7, 60 and120 Tablets per bottle and 30 count blister 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 ACTIVE INGREDIENT: Fluoride (as Sodium Fluoride) 0.25 mg / 0.5 mg / 1.0 mg INACTIVE INGREDIENTS: Xylitol, microcrystalline cellulose, malic acid, magnesium stearate, talc, citric acid, orange flavor, sucralose. 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 Διαβάστε το πλήρες έγγραφο