QUFLORA PEDIATRIC DROPS- vitamin a acetate, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, d-, thiamine hydrochlori

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

VITAMIN A ACETATE (UNII: 3LE3D9D6OY) (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), NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4), P

Available from:

CarWin Pharmaceutical Associates, LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Quflora® 0.25 mg/mL F* Pediatric Drops is a prescription dietary supplement providing essential vitamins, minerals and fluoride. Do not use in areas where drinking water exceeds 0.6 ppm F. Do not administer to pediatric patients less than 6 months old.

Product summary:

Quflora® 0.25 mg/mL F* Pediatric Drops in 50 mL (1 2/3 FL. OZ.) child-resistant bottles with accompanying calibrated dropper (Product Code: 15370-100-50). Rx Only Store at controlled room temperature 20°C to 25°C (68°F to 77°F). Protect from light, moisture and heat. SHAKE BEFORE USING TAMPER EVIDENT: Do not use if seal is broken or missing.

Authorization status:

unapproved drug other

Summary of Product characteristics

QUFLORA PEDIATRIC DROPS- VITAMIN A ACETATE, ASCORBIC ACID,
CHOLECALCIFEROL, .ALPHA.-
TOCOPHEROL ACETATE, D-, THIAMINE HYDROCHLORIDE, RIBOFLAVIN,
NIACINAMIDE, PYRIDOXINE
HYDROCHLORIDE, LEVOMEFOLIC ACID, CYANOCOBALAMIN, MAGNESIUM OXIDE,
CUPRIC SULFATE, AND SODIUM
FLUORIDE LIQUID
CARWIN PHARMACEUTICAL ASSOCIATES, LLC
_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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QUFLORA 0.25 MG/ML F* PEDIATRIC FLUORIDE DROPS
SUPPLEMENT FACTS
SERVING SIZE: 1 ML
SERVINGS PER CONTAINER: 50
AMOUNT PER 1 ML
% DAILY
VALUE
CHILDREN
6 MONTHS
TO UNDER
4 YEARS OF
AGE
% DAILY VALUE
FOR ADULTS AND
CHILDREN 4 OR
MORE YEARS OF
AGE
*
Vitamin A (as Acetate)
1,000 IU
40%
20%
Vitamin C (as Ascorbic Acid)
35 mg
88%
58%
Vitamin D3 (as Cholecalciferol)
400 IU
100%
100%
Vitamin E (as D-Alpha-
Tocopheryl Acetate)
5 IU
50%
17%
Thiamin (as Thiamine HCl,
Vitamin B1)
0.5 mg
71%
33%
Riboflavin (Vitamin B2)
0.6 mg
75%
35%
Niacin (as Niacinamide)
0.8 mg
9%
4%
Vitamin B6 (as Pyridoxine HCl)
0.4 mg
57%
20%
Folate (as 65 mcg Quatrefolic
((6S-5-methyltetrahydrofolic
acid, glucosamine salt
, molar
equivalent to 35 mcg of Folic
Acid))
35 mcg
18%
9%
Vitamin B12 (as
Cyanocobalamin)
2 mcg
67%
33%
Magnesium (as Magnesium
Oxide)
10 mg
5%
3%
Copper (as Cupric Sulfate)
1 mg
100%
50%
Fluoride (as Sodium Fluoride)
0.25 mg
OTHER INGREDIENTS: Purified Water, Carrageenan, Sorbitol, Propylene
Glycol, Glycerin, Grape Flavor,
Potassium Sorbate, Sodium Benzoate, Citric Acid and Sucralose.
INDICATIONS AND USAGE
Quflora® 0.25 mg/mL F* Pediatric Drops is a prescription dietary
supplement providing essential
®
Daily Value (DV) not established
®
*
*
*
vitamins, minerals and fluoride.
CONTRAINDICATIONS
Do not use in areas where drinking water exceeds 0.6 ppm F. Do not
administer to pediatric patients less
than 6 months old.
PRECAUTIONS
GENERAL
Do not use this product if you are allergic to any of the ingredients.
The suggested dose should