MULTI-VIT WITH FLUORIDE- dl-alpha-tocopheryl acetate and ascorbic acid and cholecalciferol and cyanocobalamin and niacinamide an

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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)

Available from:

Par Pharmaceutical

INN (International Name):

VITAMIN A PALMITATE

Composition:

VITAMIN A 1500 [iU] in 1 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Supplementation of the diet with nine essential vitamins. Supplementation of the diet with fluoride for caries prophylaxis. MULTI-VIT with FLUORIDE 0.25 mg drops were developed to 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 nine essential vitamins. MULTI-VIT with FLUORIDE 0.25 mg drops supply significant amounts of vitamins A, C, D, E, thiamin, riboflavin, niacin, vitamin B6 and vitamin B12 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, infants and children obtain nine essential vitamins plus fluoride.

Authorization status:

unapproved drug other

Summary of Product characteristics

MULTI-VIT WITH FLUORIDE- DL-ALPHA-TOCOPHERYL ACETATE AND ASCORBIC ACID
AND
CHOLECALCIFEROL AND CYANOCOBALAMIN AND NIACINAMIDE AND PYRIDOXINE
HYDROCHLORIDE AND RIBOFLAVIN
AND FLUORIDE AND THIAMINE HYDROCHLORIDE AND VITAMIN A PALMITATE
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 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%
Vitamin B
2 mcg
100%
67%
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
), cyanocobalamin (Vitamin B
),
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 ),
sodium hydroxide, 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 f