Indications
Indications and Usage As a supplemental source of Fluoride. 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.
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.
Warnings and precautions
Warnings Prolonged daily ingestion of quantities greater than the recommended amount may result in various degrees of dental fluorosis in pediatric patients under age 6 years, especially if the water fluoridation exceeds 0.6 ppm. Read directions carefully before using. Keep out of the reach of infants and children.
Adverse reactions
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 Method Pharmaceuticals, LLC at 877-250-3427. Store at controlled room temperature 15° to 30°C (59° to 86°F).
Official product information
This product has no Drugs@FDA application number in our table. DailyMed holds the labels the manufacturers submit.
Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.
At a glance
- Brand name
- Sodium Fluoride
- Application
- LABEL-Sodium Fluoride
- NDC
- 58657-322-50