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Generic name: 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
Drops · CarWin Pharmaceutical Associates, LLC
Dosage Form
Drops
Manufacturer
CarWin Pharmaceutical Associates, LLC
This medication contains important usage instructions, warnings, and side effect information that you should review before use.
Quflora® 0.5 mg/mL F* Pediatric Drops is a prescription dietary supplement providing essential vitamins, minerals and fluoride.
See schedule below to determine dosage. Administer orally as prescribed by a healthcare practitioner. Use with calibrated dropper for measuring doses.
| Age | Less than 0.3ppm | 0.3-0.6 ppm | Greater than 0.6 ppm |
|---|---|---|---|
| Birth-6 months | None | None | None |
| 6 months-3 years | 0.25 mg/day | None | None |
| 3-6 years | 0.50 mg/day | 0.25 mg/day | None |
| 6-16 years | 1.0 mg/day | 0.50 mg/day | None |
Dietary Fluoride Supplement dosing schedule approved by the American Dental Association (ADA), American Academy of Pediatrics (AAP) & American Academy of Pediatric Dentistry (AAPD).
Do not use in areas where drinking water exceeds 0.6 ppm F. Do not administer to pediatric patients less than 6 months old
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.
Quflora® 0.5 mg/mL F* Pediatric Drops is a light brown, dye free, grape flavored liquid.
15370-101-50
QUfLORA™
PEDIATRIC
Liquid Drops
Dietary Supplement
0.5 mg/mL Fluoride
Each dropperful (1 mL) contains:
1.1 mg sodium fluoride, USP
Rx Only • Grape Flavor
50 mL
(1⅔ fl oz.)
carwin
PHARMACEUTICAL ASSOCIATES
Quatrefolic ®
[image: MM1]Quflora® 0.5 mg/mL F* Pediatric Drops in 50 mL (1 2/3 FL. OZ.) child-resistant bottles with accompanying calibrated dropper (Product Code: 15370-101-50).
Rx Only
Photos of the product and/or packaging supplied by the manufacturer.
| 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) | 1,100 IU | 44% | 22% |
| Vitamin C (as Ascorbic Acid) | 45 mg | 113% | 75% |
| Vitamin D3 (as Cholecalciferol) | 400 IU | 100% | 100% |
| Vitamin E (as D-Alpha-Tocopheryl Acetate) | 12 IU | 120% | 40% |
| Thiamin (as Thiamine HCl, Vitamin B1) | 1 mg | 143% | 67% |
| Riboflavin (Vitamin B2) | 1 mg | 125% | 59% |
| Niacin (as Niacinamide) | 2 mg | 22% | 10% |
| Vitamin B6 (as Pyridoxine HCl) | 1 mg | 143% | 50% |
| Folate (as 150 mcg Quatrefolic® ((6S)-5-methyltetrahydrofolic acid, glucosamine salt, molar equivalent to 81 mcg of Folic Acid)) | 81 mcg | 41% | 20% |
| Vitamin B12 (as Cyanocobalamin) | 3 mcg | 100% | 50% |
| Magnesium (as Magnesium Oxide) | 12 mg | 6% | 3% |
| Copper (as Cupric Sulfate) | 1 mg | 100% | 50% |
| Fluoride (as Sodium Fluoride) | 0.5 mg |
Other Ingredients: Purified Water, Carrageenan, Sorbitol, Propylene Glycol, Glycerin, Grape Flavor, Potassium Sorbate, Sodium Benzoate, Citric Acid and Sucralose.
Folic Acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient. Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.
Call your doctor for medical advice about side effects. You may report serious side effects by calling Carwin Pharmaceutical Associates, LLC at 1-844-700-5011.
Quatrefolic® is a registered trademark of Gnosis, SpA. Covered by one or more claims of U.S. Patent # 7,947,662 CAS# 1181972-37-1
Manufactured for:
Carwin Pharmaceutical Associates, LLC
Hazlet, NJ 07730
CAR-101-02
Rev. 5/17
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