Label: FLORRAXIS- lactobacillus acidophilus,bifidobacterium animalis lactis tablet

  • NDC Code(s): 84460-602-30
  • Packager: Florrax Pharmaceutical Corp.
  • Category: HUMAN PRESCRIPTION DRUG LABEL

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 December 12, 2024

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  • DESCRIPTION

    Florraxis is an orally administered prescription probiotic dietary supplement.

  • INDICATIONS & USAGE

    Florraxis is an orally administered prescription probiotic formulation for the clinical dietary management of suboptimal nutritional status in patients where advanced supplementation is required and nutritional supplementation in physiologically stressful conditions for maintenance of good health is needed. Should be administered under the supervision of a licensed medical practitioner.

  • CONTRAINDICATIONS

    Florraxis 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.

  • WARNINGS

    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.

    Preservative Free and Gluten Free

    Allergens: 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 888-321-2821.

  • DOSAGE & ADMINISTRATION

    One tablet daily or as directed by a physician.

  • INACTIVE INGREDIENT

    Modified Cellulose, Silicon Dioxide, Magnesium Stearate.

  • HOW SUPPLIED

    Bottles of 30 Tablets (84460-602-30). 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 (4S FR 69043, 69044)

    3.) Federal register notice of March 5, 1996 (61 FR 8760)

  • STORAGE AND HANDLING

    : 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.

  • PRINCIPAL DISPLAY PANEL

    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

    label

  • INGREDIENTS AND APPEARANCE
    FLORRAXIS 
    lactobacillus acidophilus,bifidobacterium animalis lactis tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:84460-602
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LACTOBACILLUS ACIDOPHILUS (UNII: 1PRR1V42V5) (LACTOBACILLUS ACIDOPHILUS - UNII:1PRR1V42V5) LACTOBACILLUS ACIDOPHILUS16000000000 [CFU]
    BIFIDOBACTERIUM ANIMALIS LACTIS (UNII: 5307V7XW8I) (BIFIDOBACTERIUM ANIMALIS LACTIS - UNII:5307V7XW8I) BIFIDOBACTERIUM ANIMALIS LACTIS15000000000 [CFU]
    Product Characteristics
    Colorblue (light blue) Scoreno score
    ShapeOVALSize23mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84460-602-3030 in 1 BOTTLE; Type 0: Not a Combination Product12/12/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other12/12/2024
    Labeler - Florrax Pharmaceutical Corp. (119257612)