ESCAVITE LQ- vitamin a palmitate, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, d-, thiamine hydrochloride, ribofl

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, D- (UNII: A7E6112E4N) (.ALPHA.-TOCOPHEROL, D- - UNII:N9PR3490H9), THIAMINE HYDROCHLORIDE (UNII: M572600E5P) (Thiamine ION - UNII:4ABT0J945J), RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR), NIACIN (UNII: 2679MF687A) (NIACIN - UNII:2679MF687A), PYRIDOXINE HYDRO

Available from:

GM Pharmaceuticals, 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 and iron, and 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.2 Escavite® LQ Multi-vitamin with Iron and Fluoride 0.25 mg provides 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 3-6 years in areas where the drinking water contains 0.3 through 0.6 ppm of fluoride.2,3 Each 1.0 ml supplies sodium fluoride (0.25 mg fluoride per 1 mL) plus nine essential vitamins and iron. Escavite® LQ Multi-vitamin with Iron and Fluoride 0.25 mg supplies significant amounts of vitamins A,C,D,E, thiamin, riboflavin, niacin, vitamin B6, vitamin B12, and iron to supplement the diet, and to help assure the deficiencies of these nutrients will

Product summary:

Escavite® LQ Multi-vitamin with Iron and Fluoride 0.25 mg drops is an orange to dark orange liquid with an orange odor available in 50 mL bottles with accompanying calibrated dropper. (NDC 58809-877-50)

Authorization status:

unapproved drug other

Summary of Product characteristics

ESCAVITE LQ- VITAMIN A PALMITATE, ASCORBIC ACID, CHOLECALCIFEROL,
.ALPHA.-TOCOPHEROL ACETATE, D-
, THIAMINE HYDROCHLORIDE, RIBOFLAVIN, NIACIN, PYRIDOXINE
HYDROCHLORIDE, CYANOCOBALAMIN, FERRIC
PYROPHOSPHATE, FERROUS CYSTEINE GLYCINATE, AND SODIUM FLUORIDE LIQUID
GM PHARMACEUTICALS, 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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ESCAVITE LQ
ACTIVE INGREDIENT FOR CARIES PROPHYLAXIS:
EACH 1 ML CONTAINS 0.25 mg fluoride as sodium fluoride.
DES CRIPTION:
Prescription drug multi-vitamin with iron and fluoride 0.25 mg drops
EACH 1.0 ML CONTAINS (MARK ON DROPPER)
Vitamin A
1,500 IU
Vitamin C
35 mg
Vitamin D
400 IU
Vitamin E
7.5 IU
Thiamine
0.5 mg
Riboflavin
0.6 mg
Niacin
8 mg
Vitamin B6
0.4 mg
Vitamin B12
0.9 mcg
Iron
6 mg
Fluoride
0.25 mg
OTHER INGREDIENTS:
Ascorbic Acid (Vitamin C), Carrageenan, Cholecalciferol (Vitamin D3),
Citric Acid, Cyanocobalamin
(Vitamin B12), D-alpha-tocopheryl acetate (Vitamin E), Ferrous Glycine
Cysteinate,
Ferric Pyrophosphate, Glycerin, Niacin, Orange Flavor, Potassium
Sorbate, Propylene Glycol,
Purified Water, Pyridoxine Hydrochloride (Vitamin B6), Riboflavin
(Vitamin B2),
Thiamin Hydrochloride (Vitamin B1), Vitamin A Palmitate, and
Sucralose.
CLINICAL PHARMACOLOGY:
It is well established that fluoridation of the water supply (1ppm
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
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 contin