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1) CLINICAL PHARMACOLOGY: 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.

2) INDICATIONS AND USAGE: As an aid in the prevention of dental caries.

3) CONTRAINDICATIONS: sodium fluoride should not be used in areas where the community water supply contains more than 0.6 ppm of fluoride ion.

4) WARNINGS: The recommended dosage of sodium fluoride should not be exceeded. Excessive doses may produce mottling of the tooth enamel and bone changes. The dosage of fluoride should be adjusted if the local water supply contains natural or added fluoride.

5) PRECAUTIONS: Incompatability of fluoride with dairy foods has been reported due to formation of calcium fluoride, which is poorly absorbed.

6) ADVERSE REACTIONS: Allergic rash has been rarely reported.

7) OVERDOSAGE: In children, acute ingestion of 10 to 20 mg of sodium fluoride may cause excessive salivation and gastrointestinal disturbances.

8) DOSAGE AND ADMINISTRATION: sodium fluoride should be taken on a continual basis through the tooth forming period to be fully effective. Specific product dosage information on each product label.

Fluoride Content of Drinking Water Birth to 6 months 6 months to Age 3 Age 3 to Age 6 Age 6 to Age 16
Less than 0.3 ppm 0 0.55 mg NaF 1.1 mg NaF 2.21 mg NaF
0.3 to 0.6 ppm 0 0 0.55 mg NaF 1.1 mg NaF
Greater than 0.6 ppm
Fluoride Supplements Contraindicated