SODIUM FLUORIDE CHEWABLE- sodium fluoride tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)

Available from:

Bryant Ranch Prepack

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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¯. Fluoride 1.0 mg Tablets are contraindicated when the fluoride content of drinking water is >0.3 ppm F¯ and should not be administered to pediatric patients under 6 years. Fluoride 0.5 mg Tablets are contraindicated when the fluoride content of drinking water is more than 0.6 ppm F¯ and should not be administered to pediatric patients under age 6 when the fluoride content of drinking water is 0.3 ppm F¯ or more or to pediatric patients under age 3 years. Fluoride 0.25 mg Tablets are co

Product summary:

Each tablet contains 0.5 mg Fluoride from 1.1 mg Sodium Fluoride. White to off-white, orange flavor, round-shaped chewable tablet. Debossed with "M161" on one side. NDC 63629-1132-1 (120 count).

Authorization status:

unapproved drug other

Summary of Product characteristics

SODIUM FLUORIDE CHEWABLE- SODIUM FLUORIDE TABLET
BRYANT RANCH PREPACK
_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 CHEWABLE TABLETS
SODIUM FLUORIDE CHEWABLE TABLETS
THIS INSERT IS FOR 1.0 MG STRENGTH TABLETS, 0.5 MG STRENGTH TABLETS,
AND 0.25
MG STRENGTH TABLETS.
RX ONLY
This product is a prescription product for the clinical dietary
management of the
metabolic processes of caries prophylaxis.
WATER F¯ CONTENT
AGES
0 PPM F¯ TO <0.3
PPM F¯
0.3 PPM F¯ TO
0.6PPM F¯
>0.6PPM F¯
3 yrs. to 6 yrs.
0.5mg*
0.25mg*
0
>6yrs. to 16 yrs.
1.0mg*
0.5mg*
0
* Per day
ACTIVE INGREDIENT: Fluoride (as Sodium Fluoride)
0.25 mg / 0.5 mg / 1.0 mg
INACTIVE INGREDIENTS: citric acid, magnesium stearate, malic acid,
microcrystalline
cellulose, orange flavor, sucralose, talc, xylitol.
CAUTION: Do not eat or drink dairy products within one hour of
fluoride administration.
Incompatibility of fluoride with dairy foods has been reported due to
formation of
calcium fluoride which is poorly absorbed.
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 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¯.
CONTRAINDICATIONS
Fluoride 1.0 mg Tablets are contraindicated when the fluoride content