LUDENT- sodium fluoride tablet, chewable

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Sancilio & Company Inc

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 0.25 mg Fluoride from 0.55 mg Sodium Fluoride. White to off-white, orange flavor, round-shaped chewable tablet. Debossed "SCI" on one side and 1006 on the other. NDC 44946-1015-2 (60 count) , NDC 44946-1015-3 (120 count), NDC 44946-1015-6 (30 count blister). Each tablet contains 0.5 mg Fluoride from 1.1 mg Sodium Fluoride. White to off-white, orange flavor, round-shaped chewable tablet. Debossed "SCI" on one side and 1007 on the other. NDC 44946-1016-7 (7 count sample size), NDC 44946-1016-2 (60 count), NDC 44946-1016-3 (120 count), NDC 44946-1016-6 (30 count blister). Each tablet contains 1.0 mg Fluoride from 2.2 mg Sodium Fluoride. White to off-white, orange flavor, round-shaped chewable tablet. Debossed "SCI" on one side and 1004 on the other. NDC 44946-1017-2 (60 count) , NDC 44946-1017-3 (120 count), NDC 44946-1017-6 (30 count blister). Store at 25° C (77° F); excursions permitted to 15° - 30° C (59° - 86° F). See USP Controlled Room Temperature. Protect from light and moisture.

Authorization status:

unapproved drug other

Summary of Product characteristics

LUDENT- SODIUM FLUORIDE TABLET, CHEWABLE
SANCILIO & COMPANY 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
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.
7, 60 and120 Tablets per bottle and 30 count blister
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
ACTIVE INGREDIENT: Fluoride (as Sodium Fluoride) 0.25 mg / 0.5 mg /
1.0 mg
INACTIVE INGREDIENTS: Xylitol, microcrystalline cellulose, malic acid,
magnesium stearate, talc, citric
acid, orange flavor, sucralose.
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