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

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

Drug Label Information

Updated November 6, 2023

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  • STATEMENT OF IDENTITY

    DOSAGE AND ADMINISTRATION

    Supplement Facts
    Serving Size 1 Tablet
    Servings Per Container 100
    Amount Per Serving% Daily Values
    Vitamin B-6 (as pyridoxine HCl)25 mg1,471%
    Folate3,668 mcg DFE (2,200 mcg folic acid)917%
    Vitamin B-12 (as cyanocobalamin)1,000 mcg41,667%

    OTHER INGREDIENTS: Dicalcium Phosphate, Microcrystalline Cellulose, Croscarmellose Sodium, Stearic Acid, Silica, Hydroxypropyl Methylcellulose, Magnesium Stearate, Polyethylene Glycol.

  • 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.

  • Tamper Evidence feature

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

  • STORAGE CONDITIONS

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

  • HEALTH CLAIM

    8857 Rev 01/20

  • PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

    61269-326-10

    FaBB
    Tablets

    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 ACID2200 ug
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN1000 ug
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE25 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    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 SUPPLEMENT10/31/201612/31/2024
    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)
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