Label: FLORRAVITE- multivitamin tablet

  • NDC Code(s): 84460-901-30
  • Packager: Florrax Pharmacuetical Corp.
  • 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 July 1, 2024

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  • Description

    Florrvite is a prescription multivitamin/multimineral dietary supplement.

  • Other Ingredients

    Microcrystalline Cellulose, Maltodextrin, Croscarmellose Sodium,®Silicon Dioxide, Stearic Acid, Magnesium Stearate, Film Coating (Hydroxypropyl®Methylcellulose, Polyethylene Glycol, itanium Dioxide, FD&C Blue# 1)

  • Indications

    Florrvite 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

    Florrvite 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. Folic acid in doses above 1.0 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.

    ALLERGIES: NONE

  • 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 800-000-0000.

  • Dosage & Administration

    One tablet daily or as directed by a physician.

  • How Supplied

    Bottles of 30 Tablets (84460-901-30). Tablet is light blue, oblong.

  • SPL UNCLASSIFIED SECTION

    *Florrax Pharmaceuticals does not represent this products code to be National Drug Code (NDC). 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 B12 deficiency (pernicious anemia) requires administration under the care of a licensed medical practitioner(64 FR 8760). 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 & 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 Corp.
    Terrell TX 7S161


    KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN

  • Package Label

    label

  • INGREDIENTS AND APPEARANCE
    FLORRAVITE 
    multivitamin tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:84460-901
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) POTASSIUM IODIDE1.15 mg
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID60 mg
    BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN0.28 mg
    LEVOMEFOLIC ACID (UNII: 8S95DH25XC) (LEVOMEFOLIC ACID - UNII:8S95DH25XC) LEVOMEFOLIC ACID1 mg
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1) .ALPHA.-TOCOPHEROL4.5 mg
    FERROUS BISGLYCINATE (UNII: SFW1D987QV) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION20 mg
    VITAMIN A (UNII: 81G40H8B0T) (VITAMIN A - UNII:81G40H8B0T) VITAMIN A300 ug
    MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM OXIDE25 mg
    PYRIDOXINE (UNII: KV2JZ1BI6Z) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE26 mg
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN0.013 mg
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE80 mg
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL10 ug
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1.67 mg
    Product Characteristics
    Colorblue (light blue) Scoreno score
    ShapeOVALSize12mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84460-901-3030 in 1 BOTTLE; Type 0: Not a Combination Product07/01/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other07/01/2024
    Labeler - Florrax Pharmacuetical Corp. (119257612)