Label:
FLORRAXYL- beta carotene, ascorbic acid, cholecalciferol, dl-alpha tocopherol acetate, pyridoxine hci, biotin, folate, c...
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  • NDC Code(s): 84460-903-30
  • Packager: Florrax Pharmaceutical
  • 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 January 3, 2025

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  • DESCRIPTION
    Florraxyl is a prescription multivitamin/multimineral dietary supplement.
  • INDICATIONS & USAGE
    Florraxyl is a prescription multivitamin/multi­mineral dietary supplement formulated for the clinical dietary management of a buoptimal nutritional status in patients where advanced folate, vitamin ...
  • CONTRAINDICATIONS
    Florraxyl is contraindicated in patients with a known hypersensitivity to any of the ingredients.
  • PRECAUTIONS
    Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B 12 deficient. Felic acid in doses above 1.0 mg daily may obscure ...
  • WARNINGS AND PRECAUTIONS
    Accidental overdose of iron-containing products is a leading cause of fatal poising in children under 6. Keep this product out of the reach of children. In the case of accidental overdose, call a ...
  • ADVERSE REACTIONS
    Allergic sensitization has been reported following both oral and parenteral administration of folic acid. You should call your doctor for medical advice about serious adverse events. To reports ...
  • DOSAGE & ADMINISTRATION
    One tablet daily or as directed by a physician.
  • HOW SUPPLIED
    Bottles of 30 Tablets (84460-903-30). Tablet is light blue, oblong.
  • SPL UNCLASSIFIED SECTION
    *Florrax Pharmaceuticals does not represent this products code to be National Drug Code INDC). Products codes are formatted according to standard industry practice, to meet the formatting ...
  • STORAGE AND HANDLING
    STORAGE: Store at 20- 25 degree C (68-77 F) excersions permitted to 15 -30 degree C (59-86 F) {See USP controlled Room Temperature} Avoid excessive heat, light and moisture. TAMPER EVIDENT: Do ...
  • PRINCIPAL DISPLAY PANEL
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  • INGREDIENTS AND APPEARANCE
    Product Information