MULTI-VITAMIN FLUORIDE ascorbic acid cholecalciferol .alpha.-tocopherol acetate thiamine hydrochloride riboflavin 5-phosphate so

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Vitamin A (UNII: 81G40H8B0T) (Vitamin A - UNII:81G40H8B0T)

Available from:

Stratus Pharmaceuticals

INN (International Name):

Vitamin A

Composition:

Vitamin A 1500 [iU] in 1 mL

Prescription type:

PRESCRIPTION DRUG

Authorization status:

unapproved drug other

Summary of Product characteristics

MULTI-VITAMIN FLUORIDE- VITAMIN A, ASCORBIC ACID, CHOLECALCIFEROL,
.ALPHA.-TOCOPHEROL
ACETATE, THIAMINE HYDROCHLORIDE, RIBOFLAVIN 5-PHOSPHATE SODIUM,
NIACINAMIDE, PYRIDOXINE
HYDROCHLORIDE, CYANOCOBALAMIN, AND SODIUM FLUORIDE LIQUID
STRATUS PHARMACEUTICALS
_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 FLUORIDE DROPS 0.5 MG PER ML
DESCRIPTION
PERCENTAGE OF U.S. RECOMMENDED DAILY
ALLOWANCE
EACH 1.0 ML SUPPLIES:
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)
0.5 mg
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,
glycerin, methylparaben, oil of
orange, polysorbate 80, purified water, sodium benzoate and sodium
hydroxide.
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 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 + 20H-
(Hydroxyapatite) (Fluorapatite)
Three stages of fluoride deposition in t