SODIUM FLUORIDE CHERRY- sodium fluoride tablet, chewable

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

现在购买

产品特点 产品特点 (SPC)
11-09-2019

有效成分:

Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O)

可用日期:

HTO Nevada Inc.

INN(国际名称):

Sodium Fluoride

组成:

Fluoride Ion 0.5 mg

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

For once daily, self-administered, 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.  Kirkman's 1.1 mg Sodium Fluoride Tablets were developed to provide systemic fluoride for use as a supplement in pediatric patients form 6 months to 16 years of age living in areas where the drinking water fluoride content does not exceed 0.6 ppm (F). Krikman's 1.1 mg Sodium Fluoride Tablets, are contraindicated when the fluoride content of drinking water is 0.6 ppm (F) or more and should not be administered to pediatric patients under the age of 6 months.  Do not administer fluoride (any strength) to pediatric patients under age 6 months. The use of Kirkman's 1.1 mg Sodium Fluoride Tablets as a caries preventive in pediatric age groups 6 months to 16 years is supported by evidence from adequate and well-controlled studies

授权状态:

unapproved drug other

产品特点

                                SODIUM FLUORIDE CHERRY- SODIUM FLUORIDE TABLET, CHEWABLE
HTO NEVADA 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 CHEWABLE TABLETS
DESCRIPTION:
Kirkman's 1.1 mg (0.5 mg fluoride ion) Sodium Fluoride Tablets are dye
free. Each 1.1 mg (half
strength) tablet contains 0.5 mg of the fluoride ion (F) from 1.1 mg
sodium fluoride (NaF). Each tablet
for oral administration contain sodium fluoride equivalent to 0.5 mg
of the fluoride ion and the
following inactive ingredients: Lactose, Cherry Flavor, Saccharin
Sodium and Magnesium Stearate.
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-administered, 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. Kirkman's 1.1 mg Sodium
Fluoride Tablets were developed to provide systemic fluoride for use
as a supplement in pediatric
patients form 6 months to 16 years of age living in areas where the
drinking water fluoride content does
not exceed 0.6 ppm (F).
CONTRAINDICATIONS:
Krikman's 1.1 mg Sodium Fluoride Tablets, are contraindicated when the
fluoride content of drinking
water is 0.6 ppm (F) or more and should not be administered to
pediatric patients under the age of 6
months. Do not administer fluoride (any strength) to pediatric
patients under age 6 months.
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
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