Suggested Use:

INDICATIONS AND USAGE: For once daily self-applied systemic use as a dental caries preventative. 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.1

Warnings:

CONTRAINDICATIONS: Fluoride 1 mg F- Tablets are contraindicated when the fluoride content of drinking water is 0.3 ppm F- or more and should not be administered to pediatric patients under age 6 years. Fluoride 0.5 mg F- 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 For more or to pediatric patients under age 3 years. Fluoride 0.25 mg F- 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 Fluoride Chewable Tablets (any strength) to pediatric patients under age 3 years due to choking hazard.

Drug Interactions: 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.

WARNINGS: 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 reach of infants and children. PRECAUTIONS: General: Please refer to the CONTRAINDICATIONS, WARNINGS and OVERDOSAGE sections for overdosage concerns. Use in pediatric patients below the age of 3 years not recommended by current American Dental Association and American Academy of Pediatrics guidelines.

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

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.
Nursing Mothers: 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 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 Fluoride Chewable Tablets.

Geriatric Use: Fluoride Chewable Tablets (any strength) are not indicated for use in geriatric patients.

ADVERSE REACTIONS: Allergic rash and other idiosyncrasies have been rarely reported.

Storage:

STORAGE: Store in a cool, dry place at a controlled room temperature 20(0) - 25(0)C (68(0) - 77(0)F); excursions permitted to 15(0) - 30(0)C (59(0) - 86(0)F) and away from heat and sunlight. Store in original container. Dispense in a tight, light-resistant container with a child-resistant closure as defined in the USP/NF.

Does Not Contain:

DESCRIPTION: Each Fluoride Chewable Tablet is sugar free, saccharin free and erythrosine (FD&C Red Dye #3) free.