Florafol FE Pediatric 0.25 mg/mL Multivitamin and Fluoride Liquid Drops
Florafol™ FE Pediatric 0.25 mg/mL Multivitamin and Fluoride Liquid Drops
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HUMAN PRESCRIPTION DRUG LABEL
Dec 22, 2023
Pangea Pharmaceuticals, LLC
DUNS: 117751012
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
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)
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (20)
Drug Labeling Information
PRECAUTIONS SECTION
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.
HOW SUPPLIED SECTION
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.