{"adverse_reactions":["ADVERSE REACTIONS Allergic rash and other idosyncrasies have been rarely reported. To report SUSPECTED ADVERSE REACTIONS, contact Hi-Tech Pharmacal Co., Inc. at 1-800-262-9010"],"clinical_pharmacology":["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."],"contraindications":["CONTRAINDICATIONS Do not use in areas where drinking water exceeds 0.6 ppm F. Do not administer to pediatric patients less than 6 months old."],"description":["DESCRIPTION Each mL of Sodium Fluoride Drops contains 0.5 mg fluoride ion (F-) from 1.1 mg sodium fluoride (Naf). For use as a dental caries preventive in pediatric patients. Sugar-free Saccharin-free. Active Ingredients: Sodium Fluoride 0.11% (w/v). Other Ingredients: D&C red #33, FD&C yellow #6, glycerin, methylparaben, peach flavor, propylparaben, purified water. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN."],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Daily oral dose: (in areas where the drinking water contains less than 0.3 ppm F) 6 months to age 3: one half dropperful (1/2 mL); age 3-6, one dropperful (1 mL); age 6-16, two dropperfuls (2 mL). When drinking water is partially fluoridated (0.3 to 0.6 ppm F inclusive) dose as follows: 6 months to age 3, fluoride supplementation not indicated; age 3-6, one half dropperful (1/2 mL); age 6-16 , one dropperful (1mL). DOSAGE SCHEDULE* Conforms to new ADA and AAP guidelines for supplementation. * WATER F CONTENT AGE 0-0.3 PPM 0.3-0.6 PPM > 0.6 PPM 6 months to 3 years 0.25 mg F = 1/2 mL = Half dropperful 0 0 3-6 years 0.5 mg F = 1 mL = One dropperful 0.25 mg F = 1/2 mL = Half dropperful 0 6-16 years 1 mg F = 2 mL = Two dropperfuls 0.5 mg F = 1 mL = One dropperful 0 Image of Dropper"],"dosage_and_administration_table":["
DOSAGE SCHEDULE*Conforms to new ADA and AAP guidelines for supplementation.* WATER F CONTENT
AGE 0-0.3 PPM 0.3-0.6 PPM > 0.6 PPM
6 months to 3 years 0.25 mg F = 1/2 mL = Half dropperful 0 0
3-6 years 0.5 mg F = 1 mL = One dropperful 0.25 mg F = 1/2 mL = Half dropperful 0
6-16 years 1 mg F = 2 mL = Two dropperfuls 0.5 mg F = 1 mL = One dropperful 0
"],"effective_time":"20120328","how_supplied":["HOW SUPPLIED 50 mL bottles (NDC 50383-656-50) TAMPER EVIDENT: Do not accept if printed bottle seal around cap is broken or missing."],"id":"a6c5dba4-d7ca-4140-9b5d-91baf39e7ade","indications_and_usage":["INDICATIONS AND USAGE 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 Drops were developed to provide systemic fluoride for use as a supplement in pediatric patients from 6 months to age 3 and older, living in areas where the drinking water fluoride level does not exceed 0.6 ppm F."],"openfda":{},"overdosage":["OVERDOSAGE Prolonged daily ingestion of excessive fluoride will result in varying degrees of dental fluorosis. (The total amount of sodium fluoride in a bottle of 50 mL Sodium Fluoride Drops (25 mg F) conforms with the recommendations of the American Dental Association for the maximum to be dispensed at one time for safety purposes)."],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL NDC 50383-656-50 Sodium Fluoride Drops PEACH FLAVORED SUGAR AND SACCHARIN FREE Rx Only 1 2/3 FL. OZ. (50 mL) Image of Container Label - 50 mL"],"precautions":["PRECAUTIONS See “ Overdosage ” section. Incompatibility of fluoride with dairy foods has been reported due to formation of calcium fluoride which is poorly absored. Not for use in the eyes."],"references":["*REFERENCES Accepted Dental Therapeutics, Ed. 40. American Dental Association. Chicago, 1984. p.399-402. Jakush, J., New Fluoride schedule adopted. ADA News. May 16, 1994, p. 12, 14. Manufactured by: HI-TECH PHARMACAL CO., INC. AMITYVILLE, N.Y. 11701 MADE IN U.S.A. Rev. 656:03 4/09"],"set_id":"805baf40-da86-4559-9ca1-c491233fc811","spl_product_data_elements":["Sodium Fluoride Sodium Fluoride SODIUM FLUORIDE FLUORIDE ION D&C RED NO. 33 FD&C YELLOW NO. 6 GLYCERIN METHYLPARABEN PROPYLPARABEN WATER"],"version":"3","warnings":["WARNINGS See “ Contraindications ” above."]}