Label: FLORAFOL FE 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) iron (as ferrous sulfate) fluoride- as sodium fluoride solution/ drops
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Contains inactivated NDC Code(s)
NDC Code(s): 81279-101-50 - Packager: Pangea Pharmaceuticals, LLC
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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 December 22, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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DESCRIPTION
Supplement Facts
Serving Size : 1mL
Servings per container: 50% Daily Value
Amount per serving 1mL
Infants 7-12 months
Children
1-3 yrsChildren
4-8 yrsVITAMIN 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%
Iron (as Ferrous Sulfate)
9.5 mg 86% 136% 95% 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.
- 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.
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).
- DESCRIPTION
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HOW SUPPLIED
Florafol™ FE 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: 81279-101-50).
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. - TAMPER EVIDENT
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton
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INGREDIENTS AND APPEARANCE
FLORAFOL FE 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) iron (as ferrous sulfate) fluoride (as sodium fluoride) solution/ dropsProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:81279-101 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) (VITAMIN A - UNII:81G40H8B0T) VITAMIN A 450 ug 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 10 ug in 1 mL .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1) .ALPHA.-TOCOPHEROL 3.35 mg 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 PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE 0.4 mg in 1 mL FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 117 ug in 1 mL CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN 2 ug in 1 mL SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.25 mg in 1 mL FERROUS SULFATE (UNII: 39R4TAN1VT) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION 9.5 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) SODIUM BENZOATE (UNII: OJ245FE5EU) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) POTASSIUM CARBONATE (UNII: BQN1B9B9HA) .ALPHA.-D-GLUCURONIC ACID (UNII: M7Y086VB5G) 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:81279-101-50 1 in 1 CARTON 12/20/2023 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 12/20/2023 Labeler - Pangea Pharmaceuticals, LLC (117751012)