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.
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¯.
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 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. Do not administer Sodium Fluoride Chewable Tablets (any strength) to pediatric patients under age 3 years. Sodium Fluoride Chewable Tablets (any strength) are not indicated for use in adults.
Prolonged daily ingestion of excessive fluoride will result in varying degrees of fluorisis. Accidental ingestion of large amounts of fluoride may result in acute burning in the mouth and sore tongue. Nausea, vomiting, and diarrhea may occur soon after ingestion (within 30 minutes) and are accompanied by salivation, hematemesis, and epigastric cramping abdominal pain. These symptoms may persist for 24 hours. 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. 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. 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. A treatment dose of Sodium Fluoride Chewable Tablets contains 0.25, 0.5 or 1 mg fluoride. The treatment of choice depends upon the age of the child and the water fluoride content. A bottle of 120 0.25 mg tablets contains 30 mg fluoride. A bottle of 120 0.5 mg tablets contains 60 mg fluoride. A bottle of 120 1 mg tablets contains 120 mg fluoride. [The total amount of sodium fluoride in a bottle of 120 Fluoride Chewable Tablets (all strengths) conforms with the recommended amount of the American Dental Association for the maximum to be dispensed at one time for safety purposes.]
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. Read directions carefully before using. This product, as all chewable tablets, is not recommended for children under age 3 due to risk of choking. Keep out of the reach of infants and children.