WELLFOLA- beta carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, pyridoxine hydrochloride, biotin, folic acid, levomefolate calcium, cyanocobalamin, calcium carbonate, magnesium oxide, ferrous bisglycinate, and potassium iodide tablet

WellFola by

Drug Labeling and Warnings

WellFola by is a Other medication manufactured, distributed, or labeled by Redmont Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

  • HEALTH CLAIM

    This product is a prescription-folate with or without other dietary ingredients that – 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 (38 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° C (68°-77°F) excursions permitted to 15°-30°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.

  • HEALTH CLAIM

    MADE IN USA

    Distributed by:

    Redmont Pharmaceuticals, LLC
    Birmingham, AL 35209
    800-986-5909

    Ferrochel™ is a trademark of Albion Laboratories, Inc.

    These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

    KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN

    © 2023 Redmont Pharmaceuticals, LLC
    365111-0623

  • PRINCIPAL DISPLAY PANEL - 30 Tablet Bottle Label

    71741-365-30

    WellFola

    DIETARY SUPPLEMENT

    30 TABLETS

    Dispensed by Prescription

    PRINCIPAL DISPLAY PANEL - 30 Tablet Bottle Label
  • INGREDIENTS AND APPEARANCE
    WELLFOLA 
    beta carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, pyridoxine hydrochloride, biotin, folic acid, levomefolate calcium, cyanocobalamin, calcium carbonate, magnesium oxide, ferrous bisglycinate, and potassium iodide tablet
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:71741-365
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BETA CAROTENE (UNII: 01YAE03M7J) (BETA CAROTENE - UNII:01YAE03M7J) BETA CAROTENE300 ug
    Ascorbic Acid (UNII: PQ6CK8PD0R) (Ascorbic Acid - UNII:PQ6CK8PD0R) Ascorbic Acid60 mg
    Cholecalciferol (UNII: 1C6V77QF41) (Cholecalciferol - UNII:1C6V77QF41) Cholecalciferol10 ug
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1) .ALPHA.-TOCOPHEROL ACETATE4.5 mg
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE26 mg
    Biotin (UNII: 6SO6U10H04) (Biotin - UNII:6SO6U10H04) Biotin0.280 mg
    Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8) Folic Acid0.400 mg
    LEVOMEFOLATE CALCIUM (UNII: A9R10K3F2F) (LEVOMEFOLIC ACID - UNII:8S95DH25XC) LEVOMEFOLIC ACID0.600 mg
    Cyanocobalamin (UNII: P6YC3EG204) (Cyanocobalamin - UNII:P6YC3EG204) Cyanocobalamin0.013 mg
    Calcium Carbonate (UNII: H0G9379FGK) (Calcium Cation - UNII:2M83C4R6ZB) Calcium Cation80 mg
    Magnesium Oxide (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM CATION25 mg
    FERROUS BISGLYCINATE (UNII: SFW1D987QV) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION20 mg
    Potassium Iodide (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) IODIDE ION0.150 mg
    Inactive Ingredients
    Ingredient NameStrength
    MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y)  
    Maltodextrin (UNII: 7CVR7L4A2D)  
    Croscarmellose Sodium (UNII: M28OL1HH48)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    MAGNESIUM PALMITOSTEARATE (UNII: R4OXA9G5BV)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    FD&C Blue No. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:71741-365-3030 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Dietary Supplement07/13/2023
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving% Daily Value
    color
    scoring1
    shape
    size (solid drugs)19 mm
    Labeler - Redmont Pharmaceuticals, LLC (080843607)

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