FLUORIDE

Each Fluoride Chewable Tablet 0.25 mg is erythrosine (FD&C Red Dye No.3) free. Each tablet contains 0.25 mg F* from 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, croscarmellose sodium, D&C Red No. 27 aluminum lake, magnesium stearate, mannitol, microcrystalline cellulose, sucrose.

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*.

Dissolve in the mouth or chew before swallowing, preferably at bedtime after brushing teeth.

Fluoride Chewable Tablets 0.25 mg 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 3 years of age when the fluoride content of drinking water is 0.3 ppm F* or more. Do not administer Fluoride Chewable Tablets (any strength) to pediatric patients under age 6 months.

Allergic rash and other idiosyncrasies have rarely been reported. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1 (800) FDA-1088.

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.

STORAGE Store at Controlled Room Temperature, 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. *F from sodium fluoride.