DailyMed Label: FLUORIDE DROPS

DailyMed Label: Fluoride

2024

DailyMed Prescription

Fluoride

Sodium Fluoride

WINDER LABORATORIES, LLC

NDC: 75826-163

NDC: 75826-164

NDC: 75826-165

NDC: 75826-163

NDC: 75826-163

NDC: 75826-164

NDC: 75826-164

NDC: 75826-165

NDC: 75826-165

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¯.

(for dosage see table) Dissolve in the mouth or chew before swallowing, preferably at bedtime after brushing teeth. See schedule below to determine dosage.

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.

Please refer to the CONTRAINDICATIONS , WARNINGS and OVERDOSAGE sections for overdosage concerns. Use in pediatric patients below the age of 3 years is not recommended by current American Dental Associations and American Academy of Pediatrics guidelines. 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. 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. Equivocal evidence of carcinogenesis was reported for male rats treated with 2.5 and 4.1 mg/kg of body weight. In a second study, no carcinogenesis was observed in rats, males or females, treated with fluoride up to 11.3 mg/kg of body weight. This dose is at least 400 times greater than the recommended daily dose of Sodium Fluoride Chewable Tablets. Fluoride ion is not mutagenic in standard bacterial systems. 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. In vivo data is conflicting. Some studies report chromosome damage in rodents while other studies using similar protocols report negative results. Potential adverse reproductive effects of fluoride exposure in humans has not been adequately evaluated. 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. 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. This dose is approximately 200 times greater than the recommended daily dose of Sodium Fluoride Chewable Tablets. Teratogenic Effects Pregnancy Category B It has been shown that fluoride crosses the placenta of rats, but only 0.01% of the amount administered is incorporated in fetal tissue. Animal studies (rats, mice, rabbits) have shown that fluoride is not a teratogen. 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. Epidemiological studies conducted in areas with high levels of naturally fluoridated water showed no increase in birth defects. Heavy exposure to fluoride during in utero development may result in skeletal fluorosis which becomes evident in childhood. It is not known if fluoride is excreted in human milk. However, many drugs are excreted in human milk and caution should be exercised when Sodium Fluoride Chewable Tablets are administered to a nursing woman. Reduced milk production was reported in farm raised fox when the animals were fed a diet containing a high concentration of fluoride (98-137 mg/kg of body weight). No adverse effects on parturition, lactation, or offspring were seen in rats administered fluoride up to 5 mg/kg of body weight. This dose is at least 200 times greater than the recommended daily dose of Sodium Fluoride Chewable Tablets. Sodium Fluoride Chewable Tablets (any strength) are not indicated for use in geriatric patients. The use of Sodium Fluoride Chewable Tablets as a caries preventive in pediatric age groups 3 years to 16 years is supported by evidence from adequate and well controlled studies on fluoride supplementation from birth through adolescence.

Allergic rash and other idiosyncrasies have been rarely reported.

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.

120 count Chewable tablets Each tablet contains 0.25 mg Fluoride from 0.55 mg Sodium Fluoride. Pink-colored, grape flavor, un-scored, round chewable tablet, debossed with "WL" "163" on one side and plain on other side of tablet. NDC 75826-163-20 (120 count). Each tablet contains 0.5 mg Fluoride from 1.1 mg Sodium Fluoride. Peach-colored, grape flavor, un-scored, round chewable tablet, debossed with “WL" "164” on one side and plain on other side of tablet. NDC 75826-164-20 (120 count). Each tablet contains 1.0 mg Fluoride from 2.2 mg Sodium Fluoride. Purple-colored, grape flavor, un-scored, round chewable tablet, debossed with “WL” “165” on one side and plain on other side of tablet. NDC 75826-165-20 (120 count).

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.

FLUORIDE CHEWABLE TABLETS 0.25mg 120 count pack size