Label: FLUORIDE- sodium fluoride tablet, chewable

Each Fluoride Chewable Tablet 0.5 mg is erythrosine (FD&C Red Dye No. 3) free. Each tablet contains 0.5 mg F* from 1.1 mg sodium fluoride (NaF). Each tablet for oral administration contains sodium fluoride equivalent to fluoride 0.5 mg and the following inactive ingredients: croscarmellose sodium, D&C Red No. 27 aluminum lake, FD&C Blue No. 1 aluminum lake, grape flavor, magnesium stearate, mannitol, microcrystalline cellulose, sucrose.

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.

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*.

Fluoride Chewable Tablets 0.5 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 6 years of age when the fluoride content of drinking water is 0.3 ppm F* or to pediatric patients under age 3 years.

Do not administer Fluoride Chewable Tablets (any strength) to pediatric patients under age 6 months.

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.

General: Please refer to CONTRAINDICATIONS, WARNINGS, OVERDOSAGE sections for overdosage concerns. Use in pediatric patients below the age of 6 months is not recommended by current American Dental Association and American Academy of Pediatrics guidelines.

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.

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) has 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) has 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 of body weight (i.e. more than 6.9 mg fluoride/lb body weight), induce vomiting and admit immediately to a hospital facility.

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

Chewable tablets containing 0.5 mg fluoride are purple-colored, grape flavor, un-scored, round, debossed “105”. Available in bottles of 120’s and 1000’s. NDC:59088-105-73

Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].

*F from sodium fluoride.

croscarmellose sodium, D&C Red No. 27 aluminum lake, FD&C Blue No. 1 aluminum lake, grape flavor, magnesium stearate, mannitol, microcrystalline cellulose, sucrose.