Label: FABB- folic acid, cyanocobalamin, and pyridoxine hydrochloride tablet

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

Drug Label Information

Updated October 21, 2016

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

  • DOSAGE AND ADMINISTRATION

    Adults – one tablet daily or as directed by a physician.

  • STATEMENT OF IDENTITY

    Supplement Facts
    Serving Size 1 Tablet
    Servings Per Container 100
    Amount Per Serving%Daily Values
    Vitamin B-6 (as pyridoxine HCl)25 mg 1250%     
    Folic Acid2.2 mg550%     
    Vitamin B-12 (as cyanocobalamin)1 mg  16670%     

    OTHER INGREDIENTS: Calcium Carbonate, Microcrystalline Cellulose, Magnesium Stearate. Less than 1%: Ethylcellulose, Triacetin, Di-Acetylated Monoglycerides, Macrogol/PEG, Oleic Acid.

  • CAUTION

    Do not use if you are under the age of 18. If you are taking medication, are under a health professional's care, or are pregnant or nursing consult with a physician prior to use.

  • SAFE HANDLING WARNING

    KEEP OUT OF THE REACH OF CHILDREN .

  • Tamper Evidence feature

    Do not use if seal under cap is torn, broken or missing.

  • HEALTH CLAIM

    *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.
  • STORAGE CONDITIONS

    Store at controlled room temperature, 15°-30°C (59°-86°F). Protect from light and moisture.

  • HEALTH CLAIM

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

    4379L01 Rev. 10

    61269-326-10

  • PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

    FaBB

    Vitamin B6 (as Pyridoxine
    Hydrochloride) 25 mg
    Folic Acid 2.2 mg
    Vitamin B12 (as Cyanocobalamin)
    1.0 mg

    Dietary Supplement

    100 Tablets

    H2 pharma

    PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label
  • INGREDIENTS AND APPEARANCE
    FABB 
    folic acid, cyanocobalamin, and pyridoxine hydrochloride tablet
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:61269-326
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID2.2 mg
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN1 mg
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE25 mg
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)  
    TRIACETIN (UNII: XHX3C3X673)  
    DIACETYLATED MONOGLYCERIDES (UNII: 5Z17386USF)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    OLEIC ACID (UNII: 2UMI9U37CP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:61269-326-10100 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
    scoring1
    shape
    size (solid drugs)10 mm
    imprint
    Labeler - H2-Pharma, LLC (028473634)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ion Labs106499791MANUFACTURE