Label: FOLITE- folic acid, magnesium citrate, calcium citrate, vitamin d3, n-acetyl-l-cysteine tablet

  • Category: DIETARY SUPPLEMENT

Drug Label Information

Updated August 5, 2019

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  • Description

    Folite Tablets is a dietary supplement intended for oral administration

  • Indication and Usage

    Folite is indicated for folic acid supplementation and general nutritional support. May also be recommended for patients who are of advancing
    age or suffer from improper food intake.

  • Precaution

    Folic Acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive.

  • Warnings

    KEEP THIS AN ALL MEDICATION OUT OF REACH OF CHILDREN.

    For use under the supervision of a licensed physician. Dispense in a tight, light resistant container as defined in the USP/NF with a child-resistant closure.

  • Storage

    Store at 20 to 25°C (68 to 77°F) [see USP Controlled Room Temperature|
    Protect from light and moisture.

  • Dosage and Administration

    Adults-one tablet daily or as directed by physician.

    Safety and effectiveness in pediatric patients have not been established.

    Dispense in a tight, light-resistant container as defined in the USP/NF with a child-resistant closure.

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    FOLITE 
    folic acid, magnesium citrate, calcium citrate, vitamin d3, n-acetyl-l-cysteine tablet
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:50991-977
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1 mg
    Inactive Ingredients
    Ingredient NameStrength
    ACETYLCYSTEINE (UNII: WYQ7N0BPYC) 200 mg
    CHOLECALCIFEROL (UNII: 1C6V77QF41) 50 [iU]
    CALCIUM CITRATE (UNII: MLM29U2X85) 30 mg
    MAGNESIUM CITRATE (UNII: RHO26O1T9V) 30 mg
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:50991-977-3030 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    dietary supplement06/01/2019
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving% Daily Value
    scoring2
    color
    size (solid drugs)19 mm
    shape
    imprint
    Labeler - Poly Pharmaceuticals, Inc. (198449894)
    Registrant - Poly Pharmaceuticals, Inc. (198449894)
    Establishment
    NameAddressID/FEIBusiness Operations
    Formulation Technology Incorporated062525910manufacture
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