Quflora Pediatric Drops
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
Dosage Form: oral liquid
Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA.
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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 for Quflora Pediatric Drops
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.
Do not use this product if you are allergic to any of the ingredients. The suggested dose should not be exceeded, since dental fluorosis may result from continued ingestion of large amounts of fluoride. Do not eat or drink dairy products within one hour of fluoride administration since these may decrease effectiveness.
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.
Keep out of the reach of children. In case of accidental overdose, seek professional emergency assistance or contact a Poison Control Center immediately.
Quflora Pediatric Drops Dosage and Administration
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|
|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).
Quflora Pediatric Drops Description
Quflora® 0.25 mg/mL F* Pediatric Drops is a light brown, dye free, grape flavored liquid.
How is Quflora Pediatric Drops Supplied
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).
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.
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
Carwin Pharmaceutical Associates, LLC
Hazlet, NJ 07730
PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton
0.25 mg/mL Fluoride
Each dropperful (1 mL) contains:
0.55 mg sodium fluoride, USP
Rx Only • Grape Flavor
(1⅔ fl oz.)
|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
|Labeler - CarWin Pharmaceutical Associates, LLC (079217215)|
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