{"boxed_warning":["WARNINGS Keep out of the reach of children. In case of accidental overdose, seek professional emergency assistance or contact a Poison Control Center immediately."],"contraindications":["CONTRAINDICATIONS Do not use in areas where drinking water exceeds 0.6 ppm Fluoride. Do not administer to pediatric patients less than 6 months old."],"description":["Supplement Facts Serving Size : 1mL Servings per container: 50 % Daily Value Amount per serving 1mL Infants 7-12 months Children 1-3 yrs Children 4-8 yrs VITAMIN A (as Retinyl Palmitate) 450 mcg 90% 150% 113% VITAMIN C (as Ascorbic Acid) 36 mg 72% 240% 144% VITAMIN D3 (as Cholecalciferol) 10 mcg 100% 67% 67% VITAMIN E (as d-Alpha-Tocopherol Acetate) 3.35 mg 45% 38% 32% VITAMIN B1 (as Thiamine HCl) 0.5 mg 167% 100% 83% VITAMIN B2 (as Riboflavin Phosphate Sodium) 0.6 mg 150% 120% 100% NIACIN (as Niacinamide) 4 mg 100% 67% 50% VITAMIN B6 (Pyridoxine HCl) 0.4 mg 133% 80% 67% Folate (as 69 mcg Quatrefolic® ((6S)-5 Methyltetrahydrofolate, glucosamine salt, molar equivalent to 37.5 mcg of Folic Acid)) 117 mcg DFE 147% 78% 59% VITAMIN B12 (as Cyanocobalamin) 2 mcg 400% 222% 167% FLUORIDE (as Sodium Fluoride) 0.25 mg 50% 36% 25% Other Ingredients: Purified Water, Glycerin, Sorbitol, Sucralose, Sodium Benzoate, Potassium Sorbate, Sodium Carbonate, Monoammonium glycyrrhizinate, Grape Flavor.","DESCRIPTION Florafol™ Pediatric 0.25 mg/mL Fluoride, multivitamin and fluoride liquid drops is a dye free and gluten free grape flavored product."],"description_table":["
Supplement Facts Serving Size : 1mL Servings per container: 50
% Daily Value
Amount per serving 1mLInfants 7-12 monthsChildren 1-3 yrs Children 4-8 yrs
VITAMIN A(as Retinyl Palmitate) 450 mcg90%150%113%
VITAMIN C(as Ascorbic Acid) 36 mg72%240%144%
VITAMIN D3(as Cholecalciferol) 10 mcg100%67%67%
VITAMIN E(as d-Alpha-Tocopherol Acetate) 3.35 mg45%38%32%
VITAMIN B1(as Thiamine HCl) 0.5 mg167%100%83%
VITAMIN B2(as Riboflavin Phosphate Sodium) 0.6 mg150%120%100%
NIACIN(as Niacinamide) 4 mg100%67%50%
VITAMIN B6(Pyridoxine HCl) 0.4 mg133%80%67%
Folate(as 69 mcg Quatrefolic® ((6S)-5 Methyltetrahydrofolate, glucosamine salt, molar equivalent to 37.5 mcg of Folic Acid)) 117 mcg DFE147%78%59%
VITAMIN B12(as Cyanocobalamin) 2 mcg400%222%167%
FLUORIDE (as Sodium Fluoride) 0.25 mg50%36%25%
"],"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)* Age Less than 0.3ppm 0.3-0.6 ppm Greater than 0.6 ppm Birth-6 months 6 months-3 years 3-6 years None 0.25 mg/day† 0.50 mg/day† None None 0.25 mg/day None None None 6-16 years 1.0 mg/day 0.50 mg/day None * 1.0 part per million (ppm) = 1 milligram/liter (mg/L) † 2.2 mg sodium fluoride contains 1 mg fluoride ion 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":["
Age Less than 0.3ppm 0.3-0.6 ppm Greater than 0.6 ppm
Birth-6 months6 months-3 years3-6 years None 0.25 mg/day† 0.50 mg/day† None None 0.25 mg/day None None None
6-16 years 1.0 mg/day 0.50 mg/day None
"],"effective_time":"20250515","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.","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 Pangea Pharmaceuticals, LLC, at 1-855-892-8224."],"how_supplied":["HOW SUPPLIED Florafol™ Pediatric 0.25 mg/mL Fluoride is supplied in 50 mL (1-2/3 fl. oz.) child-resistant bottles with accompanying calibrated dropper (Product Code: 81279-100-50). Rx Only STORAGE Store in a cool, dry place at room temperature 68 °F to 77 °F (20 °C to 25 °C) away from direct heat and sunlight. Do not refrigerate this product. SHAKE WELL BEFORE USE CAUTION Do not use this product if you are allergic to any of the ingredients. Take this product at least 2 hours before or after taking any products containing calcium (including milk, yogurt, other dairy products) or aluminum/magnesium hydroxide (e.g., certain antacids/laxatives) since these may decrease effectiveness. Prolonged daily ingestion of excessive fluoride may result in varying degrees of dental fluorosis."],"id":"35304d25-acea-4abd-e063-6394a90a3acf","indications_and_usage":["INDICATIONS & USAGE Florafol™ Pediatric 0.25 mg/mL Fluoride, is a multivitamin and fluoride prescription product providing essential vitamins, minerals and fluoride."],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton 81279-100-50 Florafol ™ PEDIATRIC Multivitamin & Fluoride Liquid Drops 0.25 mg/mL Fluoride Dye Free • Gluten Free Rx Only • Grape Flavor 50 mL (1⅔ fl oz.) label 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 Pangea Pharmaceuticals, LLC, at 1-855-892-8224. WARNINGS Keep out of the reach of children. In case of accidental overdose, seek professional emergency assistance or contact a Poison Control Center immediately."],"set_id":"263e77a5-4d0e-4cec-b2d8-04fd28ce3338","spl_product_data_elements":["Florafol Pediatric 0.25 mg/mL Multivitamin and Fluoride Liquid Drops VITAMIN A (as Retinyl Palmitate) VITAMIN C (as Ascorbic Acid) VITAMIN D3 (as Cholecalciferol) VITAMIN E (as d-Alpha-Tocopherol Acetate) VITAMIN B1 (as Thiamine HCl) VITAMIN B2 (as Riboflavin Phosphate Sodium) NIACIN (as Niacinamide) VITAMIN B6 (Pyridoxine HCl) Folate (as 69 mcg Quatrefolic ((6S)-5 Methyltetrahydrofolate, glucosamine salt, molar equivalent to 37.5 mcg of Folic Acid)) VITAMIN B12 (as Cyanocobalamin) FLUORIDE (as Sodium Fluoride) WATER GLYCERIN SORBITOL SUCRALOSE SODIUM BENZOATE POTASSIUM SORBATE POTASSIUM CARBONATE .ALPHA.-D-GLUCURONIC ACID VITAMIN A PALMITATE VITAMIN A ASCORBIC ACID ASCORBIC ACID CHOLECALCIFEROL CHOLECALCIFEROL .ALPHA.-TOCOPHEROL ACETATE .ALPHA.-TOCOPHEROL THIAMINE HYDROCHLORIDE THIAMINE ION THIAMINE RIBOFLAVIN RIBOFLAVIN NIACINAMIDE NIACINAMIDE PYRIDOXINE HYDROCHLORIDE PYRIDOXINE FOLIC ACID FOLIC ACID CYANOCOBALAMIN CYANOCOBALAMIN SODIUM FLUORIDE FLUORIDE ION"],"spl_unclassified_section":["","TAMPER EVIDENT Do not use if seal is broken or missing.","Quatrefolic® is a registered trademark of Gnosis, SpA. Manufactured for: Pangea Pharmaceuticals, LLC, Brielle, NJ 08730 Rev 12/2023"],"storage_and_handling":["STORAGE Store in a cool, dry place at room temperature 68 °F to 77 °F (20 °C to 25 °C) away from direct heat and sunlight. Do not refrigerate this product. SHAKE WELL BEFORE USE"],"version":"2"}