Sodium Fluoride Drops 0.5 mg Drops Peach Flavored
Drug Labeling and Warnings
Drug Details [pdf]
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.
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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.
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.
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 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.
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 |
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| Labeler - Mayne Pharma Inc (867220261) |
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