MULTIVITAMIN WITH FLUORIDE- sodium fluoride tablet, chewable

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O), VITAMIN A (UNII: 81G40H8B0T) (VITAMIN A - UNII:81G40H8B0T), ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R), SODIUM ASCORBATE (UNII: S033EH8359) (ASCORBIC ACID - UNII:PQ6CK8PD0R), CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41), .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01), THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J94

Dostupno od:

PureTek Corporation

INN (International ime):

SODIUM FLUORIDE

Sastav:

FLUORIDE ION 0.5 mg

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

Supplementation of the diet with ten essential vitamins. Supplementation of the diet with fluoride for caries prophylaxis. The American Academy of Pediatrics recommends that children up to the age 16, in areas where drinking water contains less than optimal levels of fluoride, receive daily fluoride supplementation. Multivitamin with Fluoride 0.5 mg Chewable Tablets provide 0.5 mg fluoride in tablet form for children 4-6 years of age in areas where the drinking water fluoride level is less than 0.3 ppm, and for children 6 years of age and above where the drinking water contains 0.3 through 0.6 ppm of fluoride. Multivitamin with Fluoride 0.5 mg Chewable Tablets supply significant amounts of Vitamins A, C, D, E, thiamine, riboflavin, niacin, vitamin B6, vitamin B12, and folate to supplement the diet, and to help assure that nutritional deficiencies of these vitamins will not develop. Thus, in a single easy-to-use preparation, children obtain ten essential vitamins and the im

Proizvod sažetak:

Multivitamin chewable tablets containing 0.5 mg fluoride are purple-colored, grape flavor, un-scored, square debossed “108” tablets are available on prescription only in bottles of 100 tablets. NDC: 59088-108-59 Store at 20° - 25°C (68°-77°F); excursions permitted to 15°– 30°C (59°– 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light resistant container with a child–resistant closure as defined in the USP/NF. All prescription substitutions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product.

Status autorizacije:

unapproved drug other

Svojstava lijeka

MULTIVITAMIN WITH 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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MULTIVITAMIN WITH FLUORIDE 0.5 MG
PRESCRIBING INFORMATION
DESCRIPTION:
OTHER
INGREDIENTS: Aspartame, Croscarmellose Sodium, Grape Flavor, Magnesium
Stearate
(vegetable source), Microcrystalline Cellulose, Stearic Acid
(vegetable source), Sucrose,
CI 45410 (Red 27 Lake), CI 42090 (FD&C Blue No. 1 Aluminum Lake).
CLINICAL PHARMACOLOGY
It is well established that fluoridation of the water supply (1 ppm
fluoride) during the
period of tooth development leads to a significant decrease in the
incidence of dental
caries.
MULTIVITAMIN WITH 0.5 MG FLUORIDE CHEWABLE TABLETS provide sodium
fluoride and
ten essential vitamins in a chewable tablet. Because the tablets are
chewable, they
provide a topical as well as systemic source of fluoride.
Hydroxyapatite is the principal
crystal for all calcified tissue in the human body. The fluoride ion
reacts with the
hydroxyapatite in the tooth as it is formed to produce the more
caries-resistant crystal,
fluorapatite. The reaction may be expressed by the equation:
Ca 10(PO 4) 6(OH) 2 + 2F- ------- Ca 10(PO 4) 6F 2 + 2OH-
(Hydroxyapatite) (Fluorapatite)
Three stages of fluoride deposition in tooth enamel can be
distinguished:
1. Small amounts (reflecting the low levels of fluoride in tissue
fluids) are incorporated
into the enamel crystals while they are being formed.
2. After enamel has been laid down, fluoride deposition continues in
the surface enamel.
Diffusion of fluoride from the surface inward is apparently
restricted.
3. After eruption, the surface enamel acquires fluoride from the
water, food,
supplementary fluoride and smaller amounts from saliva.
INDICATIONS AND USAGE
Supplementation of the diet with ten essential vitamins.
Supplementation of the diet with fluoride for caries prophylaxis.
The America