FIBRIK- .alpha.-tocopherol acetate, dl-, thiamine hydrochloride, pyridoxine hydrochloride, folic acid, cyanocobalamin, thioctic acid, and ubidecarenone capsule

Fibrik by

Drug Labeling and Warnings

Fibrik by is a Other medication manufactured, distributed, or labeled by Key Therapeutics, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

  • STORAGE

    Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature.]

    Protect from heat, light and moisture.

    KEEP OUT OF THE REACH OF CHILDREN.

    Tamper Evident

    Do not use if seal is broken or missing.

  • HEALTH CLAIM

    Manufactured for:
    Key Therapeutics, LLC
    Flowood, MS 39232

    MADE IN CANADA

    Rev. 01/18

    Dispensed by Prescription2


  • 2 This product is a prescription-folate with or without other dietary ingredients that – due to increased folate levels increased risk associated with masking of B12 deficiency (pernicious anemia) requires administration under the care of a licensed medical practitioner (61 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 (Rx). 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 statutes 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)
  • PRINCIPAL DISPLAY PANEL - 30 Capsule Bottle Label

    Product Code 70868-105-30

    Fibrik
    Capsules

    DIETARY SUPPLEMENT

    KEY
    therapeutics

    Dispensed by Prescription

    30 Capsules

    PRINCIPAL DISPLAY PANEL - 30 Capsule Bottle Label
  • INGREDIENTS AND APPEARANCE
    FIBRIK 
    .alpha.-tocopherol acetate, dl-, thiamine hydrochloride, pyridoxine hydrochloride, folic acid, cyanocobalamin, thioctic acid, and ubidecarenone capsule
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:70868-105
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01) .ALPHA.-TOCOPHEROL, DL-15 [iU]
    THIAMINE HYDROCHLORIDE (UNII: M572600E5P) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE HYDROCHLORIDE15 mg
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE12.5 mg
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1 mg
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN1 mg
    THIOCTIC ACID (UNII: 73Y7P0K73Y) (THIOCTIC ACID - UNII:73Y7P0K73Y) THIOCTIC ACID150 mg
    UBIDECARENONE (UNII: EJ27X76M46) (UBIDECARENONE - UNII:EJ27X76M46) UBIDECARENONE50 mg
    Inactive Ingredients
    Ingredient NameStrength
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:70868-105-3030 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Dietary Supplement01/03/2018
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving% Daily Value
    color
    scoring1
    shape
    size (solid drugs)21 mm
    imprint
    Labeler - Key Therapeutics, LLC (080318791)

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