Label: SYGEST COMPLEX- candida parapsilosis and penicillium glabrum tablet

  • NDC Code(s): 10424-164-01, 10424-164-02
  • Packager: Syntrion GmbH
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

Drug Label Information

Updated 01/15

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • ACTIVE INGREDIENT

    Active ingredients Purpose
    *
    Abdominal cramping, diarrhea, constipation, nausea
    Candida parapsilosis 6X *
    Penicillium frequentans 6X *
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  • Uses

    For treatment of abdominal cramping, diarrhea, constipation, and nausea.

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  • Warnings

    Stop use and ask a doctor if symptoms persist.

    As with any drug, if pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children.

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  • Directions

    Adults

    Dissolve 1 tablet in mouth or under tongue away from meals, 3 times daily, or as directed by a licensed practitioner. Consult a practitioner about children's dosages.

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  • Other information

    Store at room temperature. To report serious adverse events, contact BioResource, 321B Blodgett St., Cotati, CA 94931. Rev. 11/11

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  • Inactive ingredients

    cellulose1, lactose, beet oil1


    1
    plant based
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  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY:
    BioResource Inc., Cotati, CA 94931

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  • PRINCIPAL DISPLAY PANEL - 90 Tablet Carton

    S Syntrion®

    SyGest
    Complex

    For abdominal
    cramping, diarrhea,
    constipation and nausea

    Homeopathic Medicine

    Available through
    practitioners only

    90 Tablets

    PRINCIPAL DISPLAY PANEL - 90 Tablet Carton
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  • INGREDIENTS AND APPEARANCE
    SYGEST COMPLEX 
    candida parapsilosis and penicillium glabrum tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:10424-164
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CANDIDA PARAPSILOSIS (UNII: 0KZ676D44N) (CANDIDA PARAPSILOSIS - UNII:0KZ676D44N) CANDIDA PARAPSILOSIS 6 [hp_X]
    PENICILLIUM GLABRUM (UNII: 2IN23YUE0I) (PENICILLIUM GLABRUM - UNII:2IN23YUE0I) PENICILLIUM GLABRUM 6 [hp_X]
    Inactive Ingredients
    Ingredient Name Strength
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    LACTOSE (UNII: J2B2A4N98G)  
    BEET JUICE (UNII: IOZ32L9H3O)  
    Product Characteristics
    Color WHITE Score no score
    Shape ROUND Size 9mm
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:10424-164-01 4 in 1 CARTON
    1 10 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2 NDC:10424-164-02 9 in 1 CARTON
    2 10 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    UNAPPROVED HOMEOPATHIC 02/15/2013 01/31/2017
    Labeler - Syntrion GmbH (331883145)
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