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.
Keep out of the reach of children.
There is currently no manufacturer warning information available for this 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. Fluoride Chewable Tablets were developed to provide systemic fluoride for use as a supplement in pediatric patients from 6 months to 3 years of age and older living in areas where the drinking water fluoride content does not exceed 0.6 ppm F*.
Each Fluoride Chewable Tablet 0.25 mg is erythrosine (FD&C Red Dye No.3) free. Each tablet 0.25 mg (quarter strength) contains 0.25 mg F* from 0.55 mg sodium fluoride (NaF)
Each tablet for oral administration contains sodium fluoride equivalent to fluoride 0.25 mg and the following inactive ingredients: cherry flavor, compressible sugar, croscarmellose sodium, D and C Red No. 27 aluminum lake, magnesium stearate, mannitol, microcrystalline cellulose.
