{"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":["DESCRIPTION Quflora® 0.25 mg/mL F* Pediatric Drops is a light brown, dye free, grape flavored liquid."],"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. 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":"20170803","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® 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). Rx Only STORAGE 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."],"id":"967ee6d0-2450-4fd9-ac7a-992f0ff69b71","indications_and_usage":["INDICATIONS AND USAGE Quflora® 0.25 mg/mL F* Pediatric Drops is a prescription dietary supplement providing essential vitamins, minerals and fluoride."],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton 15370-100-50 QU f LORA™ PEDIATRIC Liquid Drops Dietary Supplement 0.25 mg/mL Fluoride Each dropperful (1 mL) contains: 0.55 mg sodium fluoride, USP 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. Other information 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."],"set_id":"60375632-baf4-4f6d-9a8d-38604b8ad860","spl_product_data_elements":["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 VITAMIN A ACETATE VITAMIN A ASCORBIC ACID ASCORBIC ACID CHOLECALCIFEROL CHOLECALCIFEROL .ALPHA.-TOCOPHEROL ACETATE, D- .ALPHA.-TOCOPHEROL, D- THIAMINE HYDROCHLORIDE THIAMINE ION THIAMINE RIBOFLAVIN RIBOFLAVIN NIACINAMIDE NIACINAMIDE PYRIDOXINE HYDROCHLORIDE PYRIDOXINE LEVOMEFOLIC ACID LEVOMEFOLIC ACID CYANOCOBALAMIN CYANOCOBALAMIN MAGNESIUM OXIDE MAGNESIUM CATION CUPRIC SULFATE CUPRIC CATION SODIUM FLUORIDE FLUORIDE ION CARRAGEENAN CITRIC ACID MONOHYDRATE GRAPE POTASSIUM SORBATE SUCRALOSE WATER"],"spl_unclassified_section":["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) 1,000 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 Daily Value (DV) not established , 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.","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-100-02 Rev. 5/17"],"spl_unclassified_section_table":["
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) 1,000 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 saltDaily Value (DV) not established, 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
"],"storage_and_handling":["STORAGE 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."],"version":"2","warnings":["WARNINGS Keep out of the reach of children. In case of accidental overdose, seek professional emergency assistance or contact a Poison Control Center immediately."]}