{"boxed_warning":["WARNING 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."],"contraindications":["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."],"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 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 Daily Value not established Other Ingredients: Purified Water, Citric Acid, Glycerin, Grape Flavor, Sorbitol, Propylene Glycol, Sucralose, Sodium Benzoate.","DESCRIPTION Quflora ® FE Pediatric Liquid Drops is a yellow, dye free, grape flavored liquid."],"description_table":["
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
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 Daily Value not established
"],"dosage_and_administration":["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) 1.0 part per million (ppm) = 1 milligram/liter (mg/L) 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 2.2 mg sodium fluoride contains 1 mg fluoride ion 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)."],"dosage_and_administration_table":["
Fluoride Ion Level In Drinking Water (ppm)1.0 part per million (ppm) = 1 milligram/liter (mg/L)
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/day2.2 mg sodium fluoride contains 1 mg fluoride ion 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
"],"effective_time":"20170419","general_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."],"how_supplied":["HOW 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). Rx Only STORAGE 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"],"id":"a843f709-c7ea-456b-8bdc-48901d1fd2d2","indications_and_usage":["INDICATIONS AND USAGE Quflora ® FE Pediatric Liquid Drops is a prescription dietary supplement providing essential vitamins, iron and fluoride."],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton 15370-102-50 QU f LORA ® FE PEDIATRIC Liquid Drops Dietary Supplement with Iron & 0.25 mg/mL Fluoride Rx Only • Grape Flavor 50 mL (1⅔ fl oz.) carwin PHARMACEUTICAL ASSOCIATES Quatrefolic ® PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton"],"precautions":["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. WARNING 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. Other information 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."],"set_id":"feb95882-69f1-4f30-91aa-505f45f3ab3f","spl_product_data_elements":["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 VITAMIN A PALMITATE VITAMIN A RETINOL ASCORBIC ACID ASCORBIC ACID CHOLECALCIFEROL CHOLECALCIFEROL .ALPHA.-TOCOPHEROL ACETATE, D- .ALPHA.-TOCOPHEROL, D- THIAMINE HYDROCHLORIDE THIAMINE ION THIAMINE RIBOFLAVIN RIBOFLAVIN NIACINAMIDE NIACINAMIDE PANTOTHENIC ACID PANTOTHENIC ACID PYRIDOXINE HYDROCHLORIDE PYRIDOXINE BIOTIN BIOTIN LEVOMEFOLATE GLUCOSAMINE LEVOMEFOLATE GLUCOSAMINE CYANOCOBALAMIN CYANOCOBALAMIN FERROUS SULFATE FERROUS CATION SODIUM FLUORIDE FLUORIDE ION WATER CITRIC ACID MONOHYDRATE GLYCERIN SORBITOL PROPYLENE SUCRALOSE SODIUM BENZOATE"],"spl_unclassified_section":["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 Manufactured for: Carwin Pharmaceutical Associates, LLC Hazlet, NJ 07730 www.carwinpharma.com Rev. 3/17"],"storage_and_handling":["STORAGE 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"],"version":"1"}