MULTI VITAMIN AND FLUORIDE- multivitamin and fluoride solution/ drops

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 (UNII: H4N855PNZ1) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1), THIAMINE HYDROCHLORIDE (UNII: M572600E5P) (THIAMINE ION - UNII:4ABT0J945J), RIBOFLAVIN 5'-PHOSPHATE SODIUM (UNII: 20RD1DZH99) (FLAVIN MONONUCLEOTIDE - UNII:7N464URE7E), NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X5

Available from:

Mayne Pharma Inc

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. The American Academy of Pediatrics recommends that children up to age 16, in areas where drinking water contains less than optimal levels of fluoride, receive daily fluoride supplementation. Multivitamin and Fluoride Supplemental Drops 0.5 mg provide fluoride in drop form for infants and young children 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 3-6 years, in areas where the drinking water contains 0.3 through 0.6 ppm of fluoride. Each 1.0 mL supplies sodium fluoride (0.5 mg fluoride) plus nine essential vitamins. The American Academy of Pediatrics recommended that infants and young children 6 months to 3 years of age, in areas where drinking water contains less than 0.3 ppm of fluoride, and children 3-6, years of age, in areas where the drinking water contains 0.3 through 0.6 ppm of fluoride, receive 0.25

Product summary:

Multivitamin and Fluoride Supplemental Drops 0.5 mg are available in 50 mL bottles with accompanying calibrated dropper, NDC 51862-162-50. Store at controlled room temperature, 20º-25ºC (68º-77ºF). [See USP Controlled Room Temperature]. After opening, store away from direct light. Close tightly after each use. REFRIGERATION IS NOT REQUIRED. Manufactured for: Libertas Pharma, Inc. Lawrenceville, GA 30043 Iss. 03/11 162-50         743625

Authorization status:

unapproved drug other

Summary of Product characteristics

MULTI VITAMIN AND FLUORIDE- MULTIVITAMIN AND FLUORIDE SOLUTION/ DROPS
MAYNE PHARMA 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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MULTI VITAMIN AND FLUORIDE SUPPLEMENTAL DROPS 0.5 MG DROPS
DESCRIPTION
*
EACH 1.0 ML SUPPLIES:
PERCENTAGE OF U.S. RECOMMENDED DAILY ALLOWANCE
INFANTS
CHILDREN UNDER 4
Vitamin A
1500 IU
100
60
Vitamin C
35 mg
100
88
Vitamin D
400 IU
100
100
Vitamin E
5 IU
100
50
Thiamine
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
0.5 mg
This product does not contain the essential vitamin folic acid.
See INDICATIONS AND USAGE section below for use by infants and young
children 6 months to 3
years of age.
ACTIVE INGREDIENT FOR CARIES PROPHYLAXIS: Fluoride as sodium fluoride.
OTHER INGREDIENTS: Ascorbic acid, caramel color, cholecalciferol,
citric acid, cyanocobalamin, D-
alpha tocopheryl acid succinate, ferrous sulfate, flavor, glycerin,
methylparaben, niacinamide,
polysorbate 80, purified water, pyridoxine HCL, riboflavin-5-phosphate
sodium, sodium benzoate,
sodium hydroxide, sucralose, thiamine HCL, 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. The reaction may be expressed by the equation:
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.
U.S. RDA not established
6
12
*
*
2. After enamel has been laid down, fluoride depos