FLUORIDE- sodium fluoride tablet, chewable

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

PureTek Corporation

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

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. Fluoride Chewable Tablets were developed to provide systemic fluoride for use as a supplement in pediatric patients from 6 months to 3 years of age and older living in areas where the drinking water fluoride content does not exceed 0.6 ppm F*. Fluoride Chewable Tablets 0.5 mg 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 6 years of age when the fluoride content of drinking water is 0.3 ppm F* or to pediatric patients under age 3 years. Do not administer Fluoride Chewable Tablets (any strength) to pediatric patients under age 6 months.

Ürün özeti:

Chewable tablets containing 0.5 mg fluoride are purple-colored, grape flavor, un-scored, round, debossed “105”. Available in bottles of 120’s and 1000’s. NDC:59088-105-73

Yetkilendirme durumu:

unapproved drug other

Ürün özellikleri

FLUORIDE- SODIUM FLUORIDE TABLET, CHEWABLE
PURETEK CORPORATION
_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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PRESCRIBING INFORMATION
DESCRIPTION
Each FLUORIDE CHEWABLE TABLET 0.5 MG is erythrosine (FD&C Red Dye No.
3) free. Each tablet
contains 0.5 mg F* from 1.1 mg sodium fluoride (NaF). Each tablet for
oral administration contains
sodium fluoride equivalent to fluoride 0.5 mg and the following
inactive ingredients: croscarmellose
sodium, D&C Red No. 27 aluminum lake, FD&C Blue No. 1 aluminum lake,
grape flavor, magnesium
stearate, mannitol, microcrystalline cellulose, sucrose.
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. Fluoride Chewable
Tablets were developed to provide systemic fluoride for use as a
supplement in pediatric patients from
6 months to 3 years of age and older living in areas where the
drinking water fluoride content does not
exceed 0.6 ppm F*.
CONTRAINDICATIONS
FLUORIDE CHEWABLE TABLETS 0.5 MG 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 6 years of age when the
fluoride content of drinking water is 0.3 ppm F* or to pediatric
patients under age 3 years.
Do not administer Fluoride Chewable Tablets (any strength) to
pediatric patients under age 6 months.
WARNINGS
Prolonged daily ingestion of quantities greater than the recommended
amount may result in var