Country: Ամերիկայի Միացյալ Նահանգներ
language: անգլերեն
source: NLM (National Library of Medicine)
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)
Mayne Pharma Inc
SODIUM FLUORIDE
FLUORIDE ION 0.5 mg in 1 mL
ORAL
PRESCRIPTION DRUG
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. Sodium Fluoride Drops 0.5 mg 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. Do not use in areas where drinking water exceeds 0.6 ppm F. Do not administer to pediatric patients less than 6 months old.
Sodium Fluoride Drops 0.5 mg is supplied in 50 mL bottles with calibrated dropper, NDC 51862-165-50. TAMPER EVIDENT: Do not accept if printed bottle seal around cap is broken or missing. Accepted Dental Therapeutics, Ed. 40. American Dental Association, Chicago, 1984, p.339-402. Jakush, J, New Fluoride schedule adopted. ADA News, May 16, 1994, p.12,14. Store at controlled room temperature 15˚ to 30˚ C (59˚ to 86˚ F). Manufactured for: Libertas Pharma, Inc. Lawrenceville, GA 30043 Iss. 03/11 165-50 743631
unapproved drug other
SODIUM FLUORIDE- SODIUM FLUORIDE SOLUTION/ DROPS MAYNE PHARMA INC _Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been_ _approved by FDA. For further information about unapproved drugs, click here._ ---------- SODIUM FLUORIDE DROPS 0.5 MG DROPS PEACH FLAVORED * Conforms to new ADA and AAP guidelines for supplementation. DOSAGE SCHEDULE * 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 DESCRIPTION Each mL of Sodium Fluoride Drops 0.5 mg 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 and saccharin- free. ACTIVE INGREDIENTS: Sodium Fluoride 0.11% (w/v). OTHER INGREDIENTS: Citric acid, methyl paraben, peach flavor, purified water, red #33, sodium benzoate, sucralose, yellow #6. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. 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. 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. Sodium Fluoride Drops 0.5 mg 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. 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. WARNINGS (See "CONTRAINDICATIONS" above. PRECAUTIONS See ""OVERDOSAGE"" section. Incompatibility of fluorid read_full_document