Label: FOLTABS 800- folic acid, cyanocobalamin, and pyridoxine hydrochloride tablet

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

Drug Label Information

Updated November 8, 2016

If you are a consumer or patient please visit this version.

  • STATEMENT OF IDENTITY

    Supplement Facts
    Serving Size 1 TabletServings Per Container 60
    Amount Per Serving% Daily Value
    Vitamin B-6 (as pyridoxine hydrochloride)10 mg500%
    Folic Acid800 mcg200%
    Vitamin B-12 (as cyanocobalamin)115 mcg1917%

    Other Ingredients: Microcrystalline cellulose, dicalcium phosphate, stearic acid, croscarmellose sodium, silica, magnesium stearate.

    Coating Ingredients: Hypromellose, polydextrose, titanium dioxide, D&C yellow #10 aluminum lake, triacetin, FD&C blue #1 aluminum lake, polyethylene glycol, FD&C yellow #6 aluminum lake.

  • Directions

    Take one tablet daily.

  • SAFE HANDLING WARNING

    KEEP OUT OF REACH OF CHILDREN.

    DO NOT USE IF SAFETY SEAL IS BROKEN OR MISSING

  • HEALTH CLAIM

    Store in a cool, dry place. Protect contents from light and moisture.

  • HEALTH CLAIM

    Rev. 09/16

    H2 pharma

    Manufactured for: H2-Pharma, LLC
    2010 Berry Chase Place
    Montgomery, AL 36117
    www.h2-pharma.com

  • PRINCIPAL DISPLAY PANEL - 800 mcg/10 mg/115 mcg Tablet Bottle Carton

    61269-325-60

    Folic Acid Combination

    FOLTABS®
    800

    Folic Acid 800 mcg,
    Vitamin B-6 10 mg,
    Vitamin B-12 115 mcg

    DIETARY SUPPLEMENT

    H2 pharma

    60 TABLETS

    PRINCIPAL DISPLAY PANEL - 800 mcg/10 mg/115 mcg Tablet Bottle Carton
  • INGREDIENTS AND APPEARANCE
    FOLTABS 800 
    folic acid, cyanocobalamin, and pyridoxine hydrochloride tablet
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:61269-325
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID800 ug
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN115 ug
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    TRIACETIN (UNII: XHX3C3X673)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:61269-325-601 in 1 CARTON
    160 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    DIETARY SUPPLEMENT10/31/2016
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving% Daily Value
    color
    scoring2
    shape
    size (solid drugs)8 mm
    imprint
    Labeler - H2-Pharma, LLC (028473634)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nexgen Pharma, Inc.048488621MANUFACTURE