MULTI-VITAMIN FLUORIDE DROPS- vitamin a, vitamin c, vitamin d, vitamin e, vitamin b1, vitamin b2, vitamin b12, niacin, vitamin b

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

VITAMIN A (UNII: 81G40H8B0T) (VITAMIN A - UNII:81G40H8B0T), THIAMINE (UNII: X66NSO3N35) (THIAMINE - UNII:X66NSO3N35), RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR), ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R), CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41), NIACIN (UNII: 2679MF687A) (NIACIN - UNII:2679MF687A), PYRIDOXINE (UNII: KV2JZ1BI6Z) (PYRIDOXINE - UNII:KV2JZ1BI6Z), CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)

Available from:

H.J. Harkins Company, Inc.

INN (International Name):

VITAMIN A

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 and D. Multi-Vitamin Fluoride Drops 0.25 mg also provide 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. The American Academy of Pediatrics recommend 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 mg of supplemental fluoride daily which is provided in a dose of 1 mL of Multi-Vitamin Fluoride 0.25 mg drops. (see Dosage and Administration). Multi-Vitamin Fluoride 0.25 mg drops supply significant amounts of vitamins A, C and D 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, children obtain e

Product summary:

Multi-Vitamin and Fluoride 0.25 mg drops is available in 50 mL bottles with accompanying calibrated dropper.

Authorization status:

unapproved drug other

Summary of Product characteristics

MULTI-VITAMIN FLUORIDE DROPS - VITAMIN A, VITAMIN C, VITAMIN D,
VITAMIN E, VITAMIN B1,
VITAMIN B2, VITAMIN B12, NIACIN, VITAMIN B6, FLOURIDE SOLUTION
H.J. HARKINS COMPANY, 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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UNKNOWN TITLE
MULTI-VITAMIN FLUORIDE DROPS
0.25 mg per mL
Rx Only
DESCRIPTION
EACH 1.0 ML SUPPLIES:
PERCENTAGE OF U.S. RECOMMENDED DAILY ALLOWANCE
CHILDREN 6 MOS TO 4 YEARS OLD
Vitamin A (as Vitamin A
palmitate)
1500
IU
60%
Vitamin C (as Ascorbic Acid)
35
mg
88%
Vitamin D (as Cholecalciferol)
400
IU
100%
Vitamin E (as D-Alpha-
Tocopheryl Acid Succinate)
5 IU
50%
Vitamin B1 (as Thiamine HCl)
0.5
mg
71%
Vitamin B2 (as Riboflavin
Phosphate Sodium)
0.6
mg
75%
Vitamin B12 (as
Cyanocobalamine)
2
mcg
67%
Niacin (as Niacinamide)
8 mg
89%
Vitamin B6 (as Pyridoxine HCl)
0.4
mg
57%
Fluoride (as Sodium Fluoride)
0.25
mg
*
* Daily Value not established
See INDICATIONS AND USAGE section for use by children 6 months to 6
years of age.
This product does not contain the essential vitamin folic acid.
ACTIVE INGREDIENT FOR CARIES PROPHYLAXIS: Fluoride as sodium fluoride.
Does not contain folic acid.
OTHER INGREDIENTS: Caramel color, cherry flavor, ferrous sulfate, oil
of orange, glycerin,
methylparaben, polysorbate 80, purified water, sodium benzoate and
sodium hydroxide.
CLINICAL PHARMACOLOGY
It is well established that fluoridation of 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:
Ca
(PO ) (OH) + 2F- CA (PO ) F + 2OH-
(Hydroxyapatite) (Fluorapatite)
Three stages of fluoride deposition in tooth enamel can be
disti