VITAMINS A, C, D AND FLUORIDE- vitamins a, c, d 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), SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)

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 Vitamins A, C, D and Fluoride 0.25 mg Drops also provides 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. Vitamins A, C, D and Fluoride 0.25 mg Drops provide fluoride in drop form for infants and young children 6 months to 3 years of age, in areas where the drinking water contains children ages 2-3 years where the drinking water contains less than 0.3 ppm of fluoride and for children over 3 years, in areas where the drinking water contains 0.3 through 0.7 ppm of fluoride. Each 1.0 mL provides sodium fluoride (0.25 mg fluoride) plus eight essential vitamins and iron. The American Academy of Pediatrics recommends that infants and young children under 6 months to 3 years of age, in areas where drinking water contains less than 0.3 ppm of fluoride, and; and for children ages 3-6 years, in areas where the dri

Product summary:

Vitamins A, C, D and Fluoride 0.25 mg Drops are available in 50 mL bottles with accompanying calibrated dropper, NDC 51862-164-50. 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. TAMPER EVIDENT: Do not use if printed bottle seal around bottle cap is broken or missing. Manufactured for: Libertas Pharma, Inc. Lawrenceville, GA 30043 Iss. 03/11 164-50         743629

Authorization status:

unapproved drug other

Summary of Product characteristics

VITAMINS A, C, D AND FLUORIDE- VITAMINS A, C, D 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._
----------
VITAMINS A, C, D AND FLUORIDE 0.25 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 (Ascorbic Acid)
35 mg
100
88
Vitamin D
400 IU
100
100
Fluoride
0.25 mg
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, ferrous sulfate, flavor,
glycerin, methylparaben, niacinamide, polysorbate 80, purified water,
sodium benzoate, sodium
hydroxide, sucralose, 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.
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, C, D and Fluoride 0.25 mg
Dro