Sodium Fluoride Chewable
Generic: SODIUM FLUORIDE
Basic Information
Manufacturer
Bryant Ranch Prepack
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
efb09948-ea45-4fea-a3c5-b98182271066
Indications & Usage
INDICATIONS AND USAGE For once daily self-applied systemic use as a dental caries preventive in pediatric patients.
It has been established that ingestion of fluoridated drinking water (1 ppm F¯) during the period of tooth development results in a significant decrease in the incidence of dental caries.
Sodium Fluoride Chewable Tablets were developed to provide systemic fluoride for use as a supplement in pediatric patients from age 3 years to age 16 years and older living in areas where the drinking water fluoride contents does not exceed 0.6 ppm F¯.
It has been established that ingestion of fluoridated drinking water (1 ppm F¯) during the period of tooth development results in a significant decrease in the incidence of dental caries.
Sodium Fluoride Chewable Tablets were developed to provide systemic fluoride for use as a supplement in pediatric patients from age 3 years to age 16 years and older living in areas where the drinking water fluoride contents does not exceed 0.6 ppm F¯.
Warnings
WARNING 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.
This product, as all chewable tablets, is not recommended for children under age 3 due to risk of choking.
Keep out of the reach of infants and children.
Read directions carefully before using.
This product, as all chewable tablets, is not recommended for children under age 3 due to risk of choking.
Keep out of the reach of infants and children.
Adverse Reactions
ADVERSE REACTIONS Allergic rash and other idiosyncrasies have been rarely reported.