Indications and uses
Florafol™ FE Pediatric 0.25 mg/mL Fluoride (with Iron), is a multivitamin and fluoride prescription product providing essential vitamins, minerals and fluoride.
Florafol FE Pediatric 0.25 mg/mL Multivitamin and Fluoride Liquid Drops
- Manufacturer
- Pangea Pharmaceuticals, LLC
- Effective date
- 2023-12-22
- Label type
- HUMAN PRESCRIPTION DRUG LABEL
- Version
- 1
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 21:16:52
Label at a glance#
ProductFlorafol FE Pediatric 0.25 mg/mL Multivitamin and Fluoride Liquid Drops
Active ingredientVITAMIN A PALMITATE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, THIAMINE HYDROCHLORIDE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, SODIUM FLUORIDE, FERROUS SULFATE
Label structure10 sections
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 mill...
Contacts and useful links#
Label contents#
Full prescribing information#
DESCRIPTION SECTION
Supplement Facts | |||||
% Daily Value | |||||
Amount per serving 1mL | Infants 7-12 months | Children | Children | ||
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® | 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
Florafol™ FE Pediatric 0.25 mg/mL Fluoride (with Iron), is a multivitamin and fluoride prescription product providing essential vitamins, minerals and fluoride.
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.
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
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, seek professional emergency assistance or contact a Poison Control Center immediately.
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
Florafol™ FE Pediatric 0.25 mg/mL Fluoride (with Iron), multivitamin and fluoride liquid drops is a dye free and gluten free grape flavored product.
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
Do not use if seal is broken or missing.
SPL UNCLASSIFIED SECTION
Quatrefolic® is a registered trademark of Gnosis, SpA.
Manufactured for:
Pangea Pharmaceuticals, LLC,
Brielle, NJ 08730
Rev 12/2023
PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton
81279-101-50
Florafol ™ FE
PEDIATRIC
Multivitamin & Fluoride Liquid Drops
0.25 mg/mL Fluoride
Dye Free • Gluten Free
Rx Only • Grape Flavor
50 mL
(1⅔ fl oz.)
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 81279-101-50 | 2025-05-28 | C162847 | 48780-1 | 2cef2736-aac8-d83d-e063-dadaa90ab31f | Florafol™ FE Pediatric 0.25 mg/mL Multivitamin and Fluoride Liquid Drops |
| 81279-101-50 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-aac8-d83d-e063-dadaa90ab31f | Florafol™ FE Pediatric 0.25 mg/mL Multivitamin and Fluoride Liquid Drops |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 81279-101 | 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 [PANGEA PHARMACEUTICALS, LLC] | 1 | Unmatched | 20231227_80f8f256-cbd0-44ed-8f49-5e5ff0beb358.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 81279-101-50 | ML - Milliliter | 81279-101 | 3feec62f-29b8-44d1-9ed9-83c5154b8b5a | 1 | 2024-12-10 |
Products#
Every source-derived product name is available through these pages.
- 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)
- VITAMIN A PALMITATE
- VITAMIN A
- ASCORBIC ACID
- CHOLECALCIFEROL
- .ALPHA.-TOCOPHEROL ACETATE
- .ALPHA.-TOCOPHEROL
- THIAMINE HYDROCHLORIDE
- THIAMINE ION
- THIAMINE
- RIBOFLAVIN
- NIACINAMIDE
- PYRIDOXINE HYDROCHLORIDE
- PYRIDOXINE
- FOLIC ACID
- CYANOCOBALAMIN
- SODIUM FLUORIDE
- FLUORIDE ION
- FERROUS SULFATE
- FERROUS CATION
- WATER
- GLYCERIN
- SORBITOL
- SUCRALOSE
- SODIUM BENZOATE
- POTASSIUM SORBATE
- POTASSIUM CARBONATE
- .ALPHA.-D-GLUCURONIC ACID
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 81279-101 | 81279-101-50 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| VITAMIN A PALMITATE | 1D1K0N0VVC | ACTIM |
| ASCORBIC ACID | PQ6CK8PD0R | ACTIB |
| CHOLECALCIFEROL | 1C6V77QF41 | ACTIB |
| .ALPHA.-TOCOPHEROL ACETATE | 9E8X80D2L0 | ACTIM |
| THIAMINE HYDROCHLORIDE | M572600E5P | ACTIR |
| RIBOFLAVIN | TLM2976OFR | ACTIB |
| NIACINAMIDE | 25X51I8RD4 | ACTIB |
| PYRIDOXINE HYDROCHLORIDE | 68Y4CF58BV | ACTIB |
| FOLIC ACID | 935E97BOY8 | ACTIB |
| CYANOCOBALAMIN | P6YC3EG204 | ACTIB |
| SODIUM FLUORIDE | 8ZYQ1474W7 | ACTIM |
| FERROUS SULFATE | 39R4TAN1VT | ACTIM |
| WATER | 059QF0KO0R | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| SORBITOL | 506T60A25R | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| POTASSIUM SORBATE | 1VPU26JZZ4 | IACT |
| POTASSIUM CARBONATE | BQN1B9B9HA | IACT |
| .ALPHA.-D-GLUCURONIC ACID | M7Y086VB5G | IACT |
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 353f64d7-d280-fda6-e063-6294a90afda1 | 80f8f256-cbd0-44ed-8f49-5e5ff0beb358 | 2025-05-16 | Boxed warning | 80f8f256-cbd0-44ed-8f49-5e5ff0beb358 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.