Quflora fe Pediatric Drops
Generic Name: multi-vitamins and iron
Dosage Form: oral drops
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 (Mark on dropper)|
|Servings per Container: 50|
|Amount Per 1 mL||% DV Children 6 months to under 4 years of age||% DV for Adults and Children 4 or more years of age|
|Vitamin A (as Palmitate)||1500 IU||60%||30%|
|Vitamin C (as Ascorbic Acid)||36 mg||90%||60%|
|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)||4 mg||45%||20%|
|Pantothenic Acid||1 mg||20%||10%|
|Vitamin B6 (as Pyridoxine HCl)||0.4 mg||57%||20%|
|Folate (as 69 mcg Quatrefolic® ((6S)-5 Methyltetrahydrofolic acid, glucosamine salt, molar equivalent to 37.5 mcg of Folic Acid))||37.5 mcg||20%||10%|
|Vitamin B12 (as Cyanocobalamin)||2 mcg||67%||33%|
|Iron (as Ferrous Sulfate)||9.5 mg||95%||53%|
|Fluoride (as Sodium Fluoride)||0.25 mg||*||*|
Other Ingredients: Purified Water, Citric Acid, Glycerin, Grape Flavor, Sorbitol, Propylene Glycol, Sucralose, Sodium Benzoate.
Indications and Usage for Quflora fe Pediatric Drops
Quflora® FE Pediatric Liquid Drops is a prescription dietary supplement providing essential vitamins, iron 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.
Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. KEEP THIS PRODUCT OUT OF REACH OF CHILDREN. In case of accidental overdose, call a doctor or poison control center immediately.
Call your doctor for medical advice about side effects. You may report serious side effects or obtain product information by calling Carwin Pharmaceutical Associates, LLC at 1-844-700-5011.
Quflora fe 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. Each dropper full 1mL contains: 0.55 mg sodium fluoride, USP.
|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 fe Pediatric Drops Description
Quflora® FE Pediatric Liquid Drops is a yellow, dye free, grape flavored liquid.
How is Quflora fe Pediatric Drops Supplied
Quflora® FE Pediatric Liquid Drops in a 50 mL (1 ⅔ fl. oz.) child-resistant bottle with accompanying calibrated dropper. (Product Code: 15370-102-50).
Store in a cool, dry place at room temperature 20°C to 25°C (68°F to 77°F) away from heat and sunlight.
SHAKE WELL BEFORE USING
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
Dietary Supplement with
Iron & 0.25 mg/mL Fluoride
Rx Only • Grape Flavor
(1⅔ fl oz.)
|Quflora fe Pediatric Drops
vitamin a palmitate, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, d-, thiamine hydrochloride, riboflavin, niacinamide, pantothenic acid, pyridoxine hydrochloride, biotin, levomefolate glucosamine, cyanocobalamin, ferrous sulfate, and sodium fluoride liquid
|Labeler - Carwin Pharmaceutical Associates, LLC (079217215)|
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