FOLASTIN- folic acid, pyridoxine hydrochloride and cyanocobalamin tablet, film coated

Folastin by

Drug Labeling and Warnings

Folastin by is a Other medication manufactured, distributed, or labeled by Acella Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

  • STORAGE:

    Store at controlled room temperature between 15° – 30° C (59° – 86° F) (See USP). Protect from heat, light and moisture. Dispense in original container with child resistant closure.

  • REFERENCES:

    1Kuzminski AM, Del Giacco EJ, Allen RH, et al: Effective Treatment of Cobalamin Deficiency with Oral Cobalamin. Blood 1998; 92:1191-1198.

    2Troen AM, Mitchell B, Sorensen B, Wener MH, Johnston A, Wood B, Selhub J, McTierman A, Yasui Y, Oral E, Potter JD, and Ulich CM: Unmetabloized Folic Acid in Plasma is Associated with Reduced Natural Killer Cell Cytoxicity among Postmenopausal Women. Journal of Nutrition 2006 Jan; 136(1): 189-194.

    3House A, et al. Effect of B-Vitamin therapy on Progression of Diabetic Nephropathy. JAMA 2010; 303(16): 1603-1609.

  • SPL UNCLASSIFIED SECTION

    MANUFACTURED FOR: Acella Pharmaceuticals, LLC
    Alpharetta, GA 30009
    1-800-541-4802
    Rev. 02282012

  • PRINCIPAL DISPLAY PANEL - Film Coated Tablets

    Medical Food                  42192-345-90

    Folastin

    For the dietary managment of low
    folate and/or hyperhomocysteinemia

    90 Tablets

    Rx Only

    Acella
    PHARMACEUTICALS, LLC

    PRINCIPAL DISPLAY PANEL - Film Coated Tablets
  • INGREDIENTS AND APPEARANCE
    FOLASTIN 
    folic acid, pyridoxine hydrochloride and cyanocobalamin tablet, film coated
    Product Information
    Product TypeMEDICAL FOODItem Code (Source)NHRIC:42192-345
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID2.5 mg
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE25 mg
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN2 mg
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)  
    FOLIC ACID (UNII: 935E97BOY8)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CYANOCOBALAMIN (UNII: P6YC3EG204)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize7mm
    FlavorImprint Code 345
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:42192-345-9090 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Medical Food08/06/2012
    Labeler - Acella Pharmaceuticals, LLC (825380939)

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