NDC 58657-160-12 (120 count). 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. For accidental ingestion of more than 15 mg fluoride/kg body weight (i.e., more than 6.9 mg fluoride/lb body weight), induce vomiting and admit immediately to a hospital facility. If more than 5 mg fluoride/kg body weight (i.e., more than 2.3 mg fluoride/lb body weight) have been ingested, induce vomiting, give orally soluble calcium (e.g., milk, 5% calcium gluconate or calcium lactate solution) and immediately seek medical assistance. Protect from light and moisture. Heavy exposure to fluoride during in utero development may result in skeletal fluorosis which becomes evident in childhood. Accidental ingestion of large amounts of fluoride may result in acute burning in the mouth and sore tongue. 3. Allergic rash and other idiosyncrasies have been rarely reported. All prescription substitutions using this product shall be pursuant to state statutes as applicable. NaturesPlus Animal Parade Source of Life Tooth Fairy Children's Chewable - Natural Vanilla Flavor - 9… Label: SODIUM FLUORIDE CHEWABLE- sodium fluoride tablet. Fluoride is a natural mineral that can slow or even reverse tooth decay. See schedule below to determine dosage. Animal studies (rats, mice, rabbits) have shown that fluoride is not a teratogen. It is not known if fluoride is excreted in human milk. Maternal exposure to 12.2 mg fluoride/kg of body weight (rats) or 13.1 mg/kg of body weight (rabbits) did not affect the litter size or fetal weight and did not increase the frequency of skeletal or visceral malformations. This product is a prescription product for the clinical dietary management of the metabolic processes of caries prophylaxis. (From 2.2 mg Sodium Fluoride) This is not an Orange Book product. Overdosage Prolonged daily ingestion of excessive fluoride will result in varying degrees of fluorosis. For once daily self-applied systemic use as a dental caries preventive in pediatric patients. 120 Tablets In a study conducted in rodents, no carcinogenesis was found in male and female rats treated with fluoride at dose levels ranging from 4.1 to 9.1 mg/kg of body weight. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. 5. Did you know that oral fluoride supplements—such as lozenges, tablets and drops—are recommended for cavity prevention for certain population groups? If less than 5 mg fluoride/kg body weight (i.e., less than 2.3 mg fluoride/lb body weight) have been ingested, give calcium (e.g., milk) orally to relieve gastrointestinal symptoms and observe for a few hours. See our timeline of dental care tips for each stage of child development. Erin is a detail-oriented writer with over seven years' experience writing unique SEO-friendly medical, health, food, cooking, dental, nutrition, weight loss, and fitness articles for reputable websites -- such as reidhospital.org, unitedconcordia.com, lovetoknow.com, fitday.com, jillianmichaels.com, livestrong.com, devinecaroline.com, and medifastblog.com. Please refer to the CONTRAINDICATIONS, WARNINGS and OVERDOSAGE sections for overdosage concerns. Fluoride 0.25 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 3 years when the fluoride content of drinking water is 0.3 ppm F¯ or more. Rx Only, NDC 58657-161-10 "Fluoride-Vitamin Supplements: Effects on Dental Caries and Fluorosis When Used in Areas with Suboptimum Fluoride in the Water Supply", JADA, 95, 965-971 (1977). Debossed with "M162" on one side. Each tablet contains 0.5 mg Fluoride from 1.1 mg Sodium Fluoride. According to the American Dental Association, children aged 6 months to 16 years who aren’t drinking fluoridated water and have a high risk for tooth decay can reap crucial benefits from oral fluoride supplements. Adverse effects on reproduction were reported for rats, mice, fox, and cattle exposed to 100 ppm or greater concentrations of fluoride in their diet or drinking water. White to off-white, orange flavor, round-shaped chewable tablet. A bottle of 120 1.0 mg tablets contains 120 mg fluoride. No fluoride in your drinking water? The treatment of choice depends upon the age of the child and the water fluoride content. She is exceptional at meeting tight deadlines and communicating professionally with clients. J. Jakush, New Fluoride Schedule Adopted, ADA News, 12, 14 (May 16, 1994). Rx Only, Other brands: Epiflur, Fluor-A-Day, Fluorabon Drops, Fluoritab, Flura-Drops, Prevident 5000 Plus, Denta 5000 Plus, Biotene, Clinpro 5000, Dentagel, SF 5000 Plus. Active Ingredient: Fluoride (as Sodium Fluoride). Many tablets do not contain fluoride which is the recommendation of dentists. Caution: Do not eat or drink dairy products within one hour of fluoride administration. Children and teens who get fluoride in their water or food supply generally shouldn’t take supplements. Prolonged daily ingestion of quantities greater than the recommended amount may result in various degrees of dental fluorosis in pediatric patients under age 6 years, especially if the water fluoridation exceeds 0.6 ppm. So knowing who should take oral fluoride supplements—and the correct dosage—is a must. Keep in mind that young children using fluoride toothpaste ingest fluoride if they accidentally swallow small amounts of toothpaste. Natural health advocates, however, question the safety of fluoride. Fort Worth, TX 76118, NDC 58657-160-12 Aasenden, R., and Peebles, T.C. All Rights Reserved. In case of accidental overdose, seek professional assistance or contact a poison control center immediately. A treatment dose of Sodium Fluoride Chewable Tablets contains 0.25, 0.5 or 1.0 mg fluoride. Oral, Biol., 23, 111–115 (1974). 1000 Tablets These symptoms may persist for 24 hours. See USP Controlled Room Temperature. Some people do not ingest enough fluoride to keep their teeth cavity-free, but consuming too much fluoride can also damage your teeth. This list includes both tablets with and without fluoride. For further information about unapproved drugs, click here. In vivo data is conflicting. This insert is for 1.0 mg strength tablets, 0.5 mg strength tablets, and 0.25 mg strength tablets. Fluoride, a mineral, is naturally present in many foods and available as a dietary supplement. 1. Do not administer Sodium Fluoride Chewable Tablets (any strength) to pediatric patients under age 3 years. 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