TRI-VIT WITH FLUORIDE AND IRON DROPS- vitamin a palmitate and ascorbic acid and cholecalciferol and ferrous sulfate and sodium f

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Compra

Scheda tecnica Scheda tecnica (SPC)
11-11-2019

Principio attivo:

VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) (VITAMIN A - UNII:81G40H8B0T), ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R), CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41), FERROUS SULFATE (UNII: 39R4TAN1VT) (FERROUS CATION - UNII:GW89581OWR), SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)

Commercializzato da:

Par Pharmaceutical

INN (Nome Internazionale):

VITAMIN A PALMITATE

Composizione:

VITAMIN A 1500 [iU] in 1 mL

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

Supplementation of the diet with vitamins A, D, C, and iron. Supplementation of the diet with fluoride for caries prophylaxsis. TRI-VIT with FLUORIDE 0.25 mg and IRON (vitamins A, D, C, iron and fluoride) drops provide fluoride in drop form for infants and young children from 6 months to 3 years of age in areas where the drinking water contains less than 0.3 ppm of fluoride and for children ages 3 to 6 years in areas where the drinking water contains 0.3 through 0.6 ppm of fluoride.2,3

Stato dell'autorizzazione:

unapproved drug other

Scheda tecnica

                                TRI-VIT WITH FLUORIDE AND IRON DROPS- VITAMIN A PALMITATE AND ASCORBIC
ACID AND
CHOLECALCIFEROL AND FERROUS SULFATE AND SODIUM FLUORIDE SOLUTION
PAR PHARMACEUTICAL
_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._
----------
TRI-VIT WITH FLUORIDE 0.25 MG AND IRON DROPS
RX ONLY
SUPPLEMENT FACTS
Dosage Size 1 mL (Mark on Dropper)
AMOUNT PER
1 ML
% DAILY VALUE
INFANTS
CHILDREN UNDER
AGE 4 YEARS
Vitamin A 1500 IU
100%
60%
Vitamin C 35 mg
100%
88%
Vitamin D 400 IU
100%
100%
Iron 10 mg
67%
100%
Fluoride 0.25 mg
*
*
*Daily Value (DV) not established
ACTIVE INGREDIENT FOR CARIES PROPHYLAXIS:
Each 1 mL contains 0.25 mg fluoride as sodium fluoride.
OTHER INGREDIENTS:
ascorbic acid (Vitamin C), caramel color, cholecalciferol (Vitamin D
), ferrous sulfate, flavor,
glycerin, polysorbate 80, purified water, vitamin A palmitate
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. 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_.
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 water, food, supplementary fluoride, and
smaller amounts from saliva.
INDICATIONS AND USAGE:
Supplementation of the diet with vitamins A, D, C, and iron.
Supplementation of the diet with fluoride
for caries prophyl
                                
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