MULTI-VIT WITH FLUORIDE AND IRON- vitamin a palmitate and ascorbic acid and cholecalciferol and .alpha.-tocopherol acetate, dl-

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

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Fachinformation Fachinformation (SPC)
11-11-2019

Wirkstoff:

VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) (VITAMIN A - UNII:81G40H8B0T), ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R), CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41), .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01), THIAMINE HYDROCHLORIDE (UNII: M572600E5P) (Thiamine ION - UNII:4ABT0J945J), RIBOFLAVIN 5'-PHOSPHATE SODIUM (UNII: 20RD1DZH99) (FLAVIN MONONUCLEOTIDE - UNII:7N464URE7E), NIACINAMIDE (UNII: 25X51I8RD4)

Verfügbar ab:

Par Pharmaceutical

INN (Internationale Bezeichnung):

VITAMIN A PALMITATE

Zusammensetzung:

VITAMIN A 1500 [iU] in 1 mL

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

Supplementation of the diet with eight essential vitamins and iron. Supplementation of the diet with fluoride for caries prophylaxis. MULTI-VIT with FLUORIDE 0.25 mg and IRON 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 Each 1 mL supplies sodium fluoride (0.25 mg fluoride) plus eight essential vitamins and iron. MULTI-VIT with FLUORIDE 0.25 mg and IRON drops supply significant amounts of vitamins A, C, D, E, thiamin, riboflavin, niacin, vitamin B6 and iron to supplement the diet, and to help assure that deficiencies of these nutrients will not develop. Thus, in a single easy-to-use preparation, infants and children obtain eight essential vitamins and iron, plus fluoride.

Berechtigungsstatus:

unapproved drug other

Fachinformation

                                MULTI-VIT WITH FLUORIDE AND IRON- VITAMIN A PALMITATE AND ASCORBIC
ACID AND
CHOLECALCIFEROL AND .ALPHA.-TOCOPHEROL ACETATE, DL- AND THIAMINE
HYDROCHLORIDE AND RIBOFLAVIN AND
NIACINAMIDE AND PYRIDOXINE HYDROCHLORIDE 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._
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MULTI-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%
Vitamin E 5 IU
100%
50%
Thiamin 0.5 mg
100%
71%
Riboflavin 0.6 mg
100%
75%
Niacin 8 mg
100%
89%
Vitamin B 0.4 mg
100%
57%
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
), citric acid, dl-alpha-tocopheryl
acetate (Vitamin E), ferrous sulfate, flavors, glycerin, niacinamide,
polysorbate 80, purified water,
pyridoxine hydrochloride (Vitamin B ), riboflavin 5’-phosphate
sodium (Vitamin B ), thiamine
hydrochloride (Vitamin B ), 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)
                                
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