Label: 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
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Contains inactivated NDC Code(s)
NDC Code(s): 15370-102-50 - Packager: Carwin Pharmaceutical Associates, LLC
- Category: HUMAN PRESCRIPTION DRUG LABEL
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.
Drug Label Information
Updated April 19, 2017
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- Official Label (Printer Friendly)
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DESCRIPTION
Supplement Facts 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 - *
- Daily Value not established
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% Biotin 3 mcg 2% 1% 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
- CONTRAINDICATIONS
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PRECAUTIONS
General
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
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.
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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.
Fluoride Ion Level In Drinking Water (ppm)* 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).
- DESCRIPTION
- HOW SUPPLIED
- TAMPER EVIDENT
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton
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INGREDIENTS AND APPEARANCE
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 liquidProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:15370-102 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) (VITAMIN A - UNII:81G40H8B0T, RETINOL - UNII:G2SH0XKK91) VITAMIN A 1500 [iU] in 1 mL ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 36 mg in 1 mL CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL 400 [iU] in 1 mL .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) (.ALPHA.-TOCOPHEROL, D- - UNII:N9PR3490H9) .ALPHA.-TOCOPHEROL, D- 5 [iU] in 1 mL THIAMINE HYDROCHLORIDE (UNII: M572600E5P) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE 0.5 mg in 1 mL RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN 0.6 mg in 1 mL NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE 4 mg in 1 mL PANTOTHENIC ACID (UNII: 19F5HK2737) (PANTOTHENIC ACID - UNII:19F5HK2737) PANTOTHENIC ACID 1 mg in 1 mL PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE 0.4 mg in 1 mL BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN 3 ug in 1 mL LEVOMEFOLATE GLUCOSAMINE (UNII: Q65PL71Q1A) (LEVOMEFOLATE GLUCOSAMINE - UNII:Q65PL71Q1A) LEVOMEFOLATE GLUCOSAMINE 37.5 ug in 1 mL CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN 2 ug in 1 mL FERROUS SULFATE (UNII: 39R4TAN1VT) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION 9.5 mg in 1 mL SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.25 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) GLYCERIN (UNII: PDC6A3C0OX) SORBITOL (UNII: 506T60A25R) PROPYLENE (UNII: AUG1H506LY) SUCRALOSE (UNII: 96K6UQ3ZD4) SODIUM BENZOATE (UNII: OJ245FE5EU) Product Characteristics Color YELLOW Score Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:15370-102-50 1 in 1 CARTON 04/21/2017 1 50 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 04/21/2017 Labeler - Carwin Pharmaceutical Associates, LLC (079217215)
