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Sodium fluoride chewable tablets for use as a dental caries preventive in pediatric patients. Sugar-free. Saccharin-free. Each 1 mg tablet (full-strength) contains 1 mg fluoride ion (F) from 2.2 mg sodium fluoride (NaF).
Active Ingredient: Sodium Fluoride 2.2 mg.
Other Ingredients: Cherry flavor, FD&C Red #40, mannitol, magnesium stearate, and microcrystalline cellulose.
It has been established that ingestion of fluoridated drinking water (1 ppm F) during the period of tooth development results in significant decrease in the incidence of dental caries. 1 Sodium fluoride tablets were developed to provide systemic fluoride for use as a supplement in pediatric patients from age 6 months to 16, living in areas where the drinking water fluoride level does not exceed 0.6 ppm F.
See schedule below to determine dosage. Dissolve in the mouth or chew before swallowing, preferably at bedtime after brushing teeth.
|
AGE |
0- 0.03PPM | Water F conten 0.3- 0.6 PPM |
|
6 Mo- 3 Yrs |
0.25 mg |
0 |
|
3 - 6 Yrs |
0.5 mg |
0.25 mg |
|
6 - 16 Yrs |
1 mg |
0.5 mg |
Store between 15°-30°C (59°-86°F).
Dispense in a tight, light resistant container as defined in the USP.
Fluoride 1 mg* Tablets are supplied in bottles of 1000 (NDC 38245-131-20) as chewable, round, pink, unscored tablets debossed "COPLEY 131" on one side and plain on the other side.
CAUTION: Federal (U. S. A.) law prohibits dispensing without prescription.
Allergic rash and other idiosyncrasies have been rarely reported.
No information provided.
See CONTRAINDICATIONS. As in the case of all medications, keep out of reach of infants and children.
See OVERDOSAGE. Incompatibility of fluoride with dairy foods has been reported due to formation of calcium fluoride which is poorly absorbed.
Prolonged daily ingestion of excessive fluoride will result in varying degrees of dental fluorosis.
Do not use in areas where the drinking water exceeds 0.3 ppm F or more. These tablets should not be administered to pediatric patients under age 6.
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.
See WARNINGS, CONTRAINDICATIONS and PRECAUTIONS.
