Label: FLORRAXYL- beta carotene, ascorbic acid, cholecalciferol, dl-alpha tocopherol acetate, pyridoxine hci, biotin, folate, cyanocobalamin, calcium carbonate, magnesium oxide, ferrocheltm, potassium iodide tablet

  • 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

If you are a consumer or patient please visit this version.

  • 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 B supplementa­tion, and maintenance of good health is needed.

  • 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 pernicious anemia in that hematologic remission can occur while neurological manifestations progress.

  • 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 doctor or poison control center immediately.

  • 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 adverse side effects or to obtain product information, contact Florrax Pharmaceuticals at 888-321-2821.

  • 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 requirement by pedigree reporting and supply-chain control including pharmacies.
    This products is a prescription-folate with or without other dietary ingredients the - due to increased folate levels increased risk associated with masking B 12 deficiency (pernicious anemia) requires administration under the care of a licensed medical practitioner(64 FR 87 60). 1-3 the most appropriate way to ensure pedigree reporting consistent with these regulatory guidelines and safety monitoring is to dispense this product only by prescription. This is not an Orange Book product. This product may be administered only under a physician's supervision and all prescriptions using this product shall be pursuant to state statues as applicable. The ingredients, indication or claims of this product are not to be construed to be Drug claims.

    1.) Federal register Notice of August 2, 1973 (39 FR 20750)
    2.) Federal Register Notice of October 17, 1980 (45 FR 69043, 69044) 3.) Federal register notice of March 5, 1996 (61 FR 8760)

  • 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 not use if seal is broken or missing.
    MADE IN USA
    Distributed by:
    888-321-2821
    Florrax Pharmaceutical

    Dallas, TX 75161


    KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    FLORRAXYL 
    beta carotene, ascorbic acid, cholecalciferol, dl-alpha tocopherol acetate, pyridoxine hci, biotin, folate, cyanocobalamin, calcium carbonate, magnesium oxide, ferrocheltm, potassium iodide tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:84460-903
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID0.67 mg
    MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM CATION25 mg
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) (.ALPHA.-TOCOPHEROL, D- - UNII:N9PR3490H9) .ALPHA.-TOCOPHEROL, D-4.5 mg
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION80 mg
    POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) IODIDE ION0.15 mg
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID60 mg
    BETA CAROTENE (UNII: 01YAE03M7J) (BETA CAROTENE - UNII:01YAE03M7J) BETA CAROTENE300 ug
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE26 mg
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN0.013 mg
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL10 ug
    BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN0.28 mg
    FERROUS BISGLYCINATE (UNII: SFW1D987QV) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION20 mg
    Product Characteristics
    ColorblueScoreno score
    ShapeOVALSize12mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84460-903-3030 in 1 BOTTLE; Type 0: Not a Combination Product01/01/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/01/2025
    Labeler - Florrax Pharmaceutical (119257612)