Label: SYREFLUX- penicillium roqueforti tablet 

  • Label RSS
  • NDC Code(s): 10424-167-01, 10424-167-02
  • Packager: Syntrion GmbH
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 02/13

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • ACTIVE INGREDIENT

    Active ingredients Purpose
    *
    Indigestion, heartburn, acid reflux, frequent belching
    Penicillium roqueforti 6X *
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  • Uses

    For treatment of indigestion, heartburn, acid reflux, and frequent belching.

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  • Warnings

    Stop use and ask a doctor if conditions persist more than 7 days.

    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. 03/12

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  • Inactive ingredients

    beet oil1, cellulose1, lactose


    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 Blister Pack Carton

    S Syntrion®

    SyReflux

    Indigestion,
    heartburn, acid reflux,
    frequent belching

    Homeopathic Medicine

    Available through
    practitioners only

    90 Tablets

    Principal Display Panel - 90 Tablet Blister Pack Carton
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  • INGREDIENTS AND APPEARANCE
    SYREFLUX 
    penicillium roqueforti tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:10424-167
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PENICILLIUM ROQUEFORTI (PENICILLIUM ROQUEFORTI) PENICILLIUM ROQUEFORTI 6 [hp_X]
    Inactive Ingredients
    Ingredient Name Strength
    BEET JUICE  
    POWDERED CELLULOSE  
    LACTOSE  
    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:10424-167-01 4 in 1 CARTON
    1 10 in 1 BLISTER PACK
    2 NDC:10424-167-02 9 in 1 CARTON
    2 10 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    UNAPPROVED HOMEOPATHIC 02/15/2013
    Labeler - Syntrion GmbH (331883145)
    Establishment
    Name Address ID/FEI Business Operations
    Spreewälder Arzneimittel GmbH 332313084 MANUFACTURE(10424-167)
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