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...
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% | |
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.
Florafol™ Pediatric 0.25 mg/mL Fluoride, is a multivitamin and fluoride prescription product providing essential vitamins, minerals and fluoride.
Do not use in areas where drinking water exceeds 0.6 ppm Fluoride. Do not administer to pediatric patients less than 6 months old.
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 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.
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.
Keep out of the reach of children. In case of accidental overdose, seek professional emergency assistance or contact a Poison Control Center immediately.
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).
Florafol™ Pediatric 0.25 mg/mL Fluoride, multivitamin and fluoride liquid drops is a dye free and gluten free grape flavored product.
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
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
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.
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
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.)
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 81279-100-50 | 2025-05-28 | C162847 | 48780-1 | 2cef2736-59fc-d83d-e063-dadaa90ab31f | Florafol™ Pediatric 0.25 mg/mL Multivitamin and Fluoride Liquid Drops |
| 81279-100-50 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-59fc-d83d-e063-dadaa90ab31f | Florafol™ Pediatric 0.25 mg/mL Multivitamin and Fluoride Liquid Drops |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 81279-100 | 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)) SOLUTION/ DROPS [PANGEA PHARMACEUTICALS, LLC] | 1 | Unmatched | 20231227_263e77a5-4d0e-4cec-b2d8-04fd28ce3338.zip |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 81279-100-50 | ML - Milliliter | 81279-100 | 79873895-d672-41cf-b35a-c5cf3bb441b9 | 1 | 2024-12-10 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 81279-100 | 81279-100-50 |
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 |
| 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 |
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 |
|---|---|---|---|---|---|---|
| 35304d25-acea-4abd-e063-6394a90a3acf | 263e77a5-4d0e-4cec-b2d8-04fd28ce3338 | 2025-05-15 | Boxed warning | 263e77a5-4d0e-4cec-b2d8-04fd28ce3338 |
Adverse event summaries are temporarily unavailable. Other product information remains available.