Label: FOLETRA- vitamin capsule

  • Category: DIETARY SUPPLEMENT
  • DEA Schedule: None
  • Marketing Status: Dietary Supplement

Drug Label Information

Updated May 12, 2025

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  • Supplement Facts

    Foletra Capsules - Dietary Supplement

    Supplement Facts

    Serving Size: 1 Capsule

    Servings Per Bottle: 30

     Ingredients Amount Per Serving%DV
     Vitamin C (as Ascorbic Acid) 90 mg 100%
     Vitamin D3 (as Cholecalciferol) 20 mcg 100%
     Vitamin E (as d-Alpha Tocopheryl Succinate) 10.05 mg 67%
     Thiamine (as Thiamine Mononitrate) 1.4 mg 116%
     Riboflavin (as Riboflavin 5 Phosphate) 1.6 mg 123%
     Niacin (as Niacinamide) 16.3 mg 101%
     Vitamin B-6 (as Pyridoxine HCl) 2.5 mg 147%
     Folate (from 1000 mcg Folic Acid) 1700 mcg DFE 425%
     Vitamin B-12 (as Methylcobalamin) 10 mcg 416%

    Other ingredients: Microcrystalline Cellulose (USP), Vegetable Capsule (cellulose, purified water)

  • Description:

    Foletra is an orally administered vitamin formulation for the clinical dietary management of suboptimal nutritional status in patients where advanced folate supplementation is needed. Foletra provides significant amounts of Vitamins B6, B12, C, D3, E, riboflavin, niacinamide, and thiamine mononitrate to supplement the diet.

  • Contraindications

    Foletra is contraindicated in patients with a known hypersensitivity to any of the contained ingredients. Do not take this product if you are presently taking mineral oil, unless directed by a licensed medical practitioner.

    Precaution

    Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B is deficient. Folic acid in doses above 1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress. Foletra should only be used under the direction and supervision of a licensed medical practitioner.

  • WARNINGS

    KEEP FOLETRA OUT OF THE REACH OF CHILDREN.
    In case of accidental overdose, call a licensed medical practitioner or poison control center immediately.
    For use under the supervision of a licensed medical practitioner.

    Consult your physician prior to using Foletra if you are pregnant, nursing, taking medication, or have a medical condition. 

  • Doseage and Administration

    Suggested use is 1 capsule taken orally once daily or as prescribed by a licensed medical practitioner. 

  • Storage and Handling

    Store at room temperature. Avoid excessive heat, light, and moisture. 

    Statements

    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.

    How Supplied

    Foletra capsules are available in 30 count bottles. 72835-440-01

    Manufactured for:
    V2 Pharma, LLC
    103 W Main Street
    Hudson, MI 49247

  • Foletra Label

    Foletra Label

  • INGREDIENTS AND APPEARANCE
    FOLETRA 
    vitamin capsule
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:72835-440
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID90 mg
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL20 ug
    .ALPHA.-TOCOPHEROL SUCCINATE, D- (UNII: LU4B53JYVE) (.ALPHA.-TOCOPHEROL, D- - UNII:N9PR3490H9) .ALPHA.-TOCOPHEROL SUCCINATE, D-10.5 mg
    THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE MONONITRATE1.4 mg
    RIBOFLAVIN 5'-PHOSPHATE (UNII: 7N464URE7E) (FLAVIN MONONUCLEOTIDE - UNII:7N464URE7E) RIBOFLAVIN 5'-PHOSPHATE1.6 mg
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE16.3 mg
    PYRIDOXINE HCL (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE2.5 mg
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1700 ug
    METHYLCOBALAMIN (UNII: BR1SN1JS2W) (METHYLCOBALAMIN - UNII:BR1SN1JS2W) METHYLCOBALAMIN10 ug
    Inactive Ingredients
    Ingredient NameStrength
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:72835-440-0130 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    dietary supplement03/06/2025
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving% Daily Value
    shape
    size (solid drugs)16 mm
    scoring1
    color
    Labeler - V2 Pharma LLC (102457346)
    Establishment
    NameAddressID/FEIBusiness Operations
    V2 Pharma LLC102457346label(72835-440) , manufacture(72835-440)
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