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 58657-161-12 A treatment dose of Sodium Fluoride Chewable Tablets contains 0.25, 0.5 or 1 mg fluoride. Stookey, G.K. and Veiswanter, B.B. Allergic rash and other idiosyncrasies have been rarely reported. 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. 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. Caution: Do not eat or drink dairy products within one hour of fluoride administration. For once daily self-applied systemic use as a dental caries preventive in pediatric patients. This insert is for 1.0 mg strength tablets, 0.5 mg strength tablets, and 0.25 mg strength tablets. LUDENT- sodium fluoride tablet, chewable  No adverse effects on parturition, lactation, or offspring were seen in rats administered fluoride up to 5 mg/kg of body weight. Fluoride ion is not mutagenic in standard bacterial systems. These symptoms may persist for 24 hours. Chewable Tablets 0.5 mg No adverse effects on parturition, lactation, or offspring were seen in rats administered fluoride up to 5 mg/kg of body weight. Sodium Fluoride This product, as all chewable tablets, is not recommended for children under age 3 due to risk of choking. 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. Sugar-free. Each tablet contains 1.0 mg Fluoride from 2.2 mg Sodium Fluoride. Take with or without food. White to off-white, orange flavor, round-shaped chewable tablet. Protect from light and moisture. It has been shown that fluoride crosses the placenta of rats, but only 0.01% of the amount administered is incorporated in fetal tissue. 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. In vivo data is conflicting. 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. Each tablet contains 0.25 mg Fluoride from 0.55 mg Sodium Fluoride. Use this medicine (sodium fluoride tablets) before bedtime, after you brush your teeth, unless your doctor tells you otherwise. Read directions carefully before using. 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¯. Aasenden, R., and Peebles, T.C. In vivo data is conflicting. This product is a prescription product for the clinical dietary management of the metabolic processes of caries prophylaxis. For further information about unapproved drugs, click here. Tablets are typically manufactured as 0.25, 0.5, and 1.0 mg fluoride ion (equal to 0.55, 1.1, and 2.2 mg sodium fluoride, respectively). Keep out of the reach of infants and children. The treatment of choice depends upon the age of the child and the water fluoride content. Debossed "SCI" on one side and 1006 on the other. Dispense in a tight, light-resistant container with a child-resistant closure as defined in the USP/NF. Oral, Biol., 23, 111–115 (1974). White to off-white, orange flavor, round-shaped chewable tablet. Each tablet contains 0.5 mg Fluoride from 1.1 mg Sodium Fluoride. However, many drugs are excreted in human milk and caution should be exercised when Sodium Fluoride Chewable Tablets are administered to a nursing woman. A treatment dose of Sodium Fluoride Chewable Tablets contains 0.25, 0.5 or 1 mg fluoride. Please refer to the CONTRAINDICATIONS, WARNINGS and OVERDOSAGE sections for overdosage concerns. Each tablet contains 0.5 mg Fluoride from 1.1 mg Sodium Fluoride. This dose is approximately 200 times greater than the recommended daily dose of Sodium Fluoride Chewable Tablets. Aasenden, R., and Peebles, T.C. It has been shown that fluoride ion has potential to induce chromosome aberrations in cultured human and rodentcells at does much higher than those to which humans are exposed. NDC 58657-160-12 (120 count). Use this medicine (sodium fluoride tablets) as ordered by your doctor. Other studies conducted in rats demonstrated that lower doses of fluoride (5 mg/kg of body weight) did not result in impaired fertility and reproductive capabilities. It has been shown that fluoride ion has potential to induce chromosome aberrations in cultured human and rodent cells at does much higher than those to which humans are exposed.

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