constant Sodium Fluoride Drops Dosage Form: oral solution/drops Overview Side Effects Professional Reviews Images More Support Group Q & A Compare Alternatives Pricing & Coupons 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. * 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 Sodium Fluoride Drops 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. Slideshow Type 1 Diabetes: Symptoms, Treatments, and Breakthroughs Sodium Fluoride Drops - 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 for Sodium Fluoride Drops 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 fluoride with dairy foods has been reported due to formation of calcium fluoride which is poorly absorbed. Not for ophthalmic use. Adverse Reactions Allergic rash and other idiosyncrasies have been rarely reported. To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Overdosage Prolonged daily ingestion of excessive fluoride will result in varying degrees of dental fluorosis. For safety purposes, the total amount of sodium fluoride in a 50 mL bottle of Sodium Fluoride Drops 0.5 mg (25 mg F) conforms with the recommendations of the American Dental Association for the maximum to be dispensed at one time. Sodium Fluoride Drops 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 (1 mL)* * Conforms to new ADA and AAP guidelines for supplementation. How is Sodium Fluoride Drops Supplied 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. *REFERENCES 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. RECOMMENDED STORAGE: 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 Container Label NDC 51862-165-50 Rx Only Sodium Fluoride Drops 0.5 mg Drops Peach Flavored SUGAR and SACCHARIN FREE For Children and Adults 1 2/3 fl. oz. (50 mL) Libertas Pharma Inc. SODIUM FLUORIDE sodium fluoride solution/ drops Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:51862-165 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 0.5 mg in 1 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE METHYLPARABEN PEACH WATER D&C RED NO. 33 SODIUM BENZOATE SUCRALOSE FD&C YELLOW NO. 6 Product Characteristics Color ORANGE (peach) Score Shape Size Flavor PEACH Imprint Code Contains Packaging # Item Code Package Description 1 NDC:51862-165-50 1 BOTTLE in 1 CARTON 1 50 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 05/21/2011 09/30/2019 Labeler - Mayne Pharma Inc (867220261) Revised: 07/2017 Mayne Pharma Inc Next User Reviews Print this page Add to My Med List More about fluoride Side Effects Drug Images Compare Alternatives Support Group Pricing & Coupons En Español 0 Reviews Add your own review/rating Drug class: minerals and electrolytes Consumer resources Fluoride ... +5 more Professional resources Sodium Fluoride Chewable Tablets (FDA) Other brands: Flura-Drops , Fluor-A-Day , Epiflur , Fluorabon Drops , Fluoritab Related treatment guides Prevention of Dental Caries FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only N Pregnancy Category Not classified N/A CSA Schedule Not a controlled drug Manufacturer Libertas Pharma Drug Class Minerals and electrolytes Related Drugs minerals and electrolytes potassium chloride , calcium carbonate , Caltrate , magnesium oxide , Klor-Con , sodium chloride Prevention of Dental Caries Biotene , Prevident , fluoride topical , Prevident 5000 Plus , Denta 5000 Plus , SF , Fluoridex , SF 5000 Plus , Clinpro 5000 , Dentagel , Prevident 5000 Sensitive , PreviDent 5000 Booster , Gelato X , Zooby , Prevident Mouthwash , Perio Med , ACT Fluoride Rinse , Neutral Sodium Fluoride Rinse , Flura-Drops , Fluorinse , Nafrinse , More... 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