Label: SYALLGEN- penicillium glabrum tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated July 7, 2011

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Penicillium frequentans 4X

  • Purpose

    Allergies

  • Uses

    For treatment of airborne allergies, contact allergies and neurodermatitis.

  • 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.

  • 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.

  • Other information

    Store at room temperature. To report serious adverse events, contact BioResource, 321B Blodgett St., Cotati, CA 94931.  Rev. 02/11

  • Inactive ingredients

    cellulose1, lactose, magnesium stearate1

    1
    plant based
  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY:
    BioResource Inc., Cotati, CA 94931

    MANUFACTURED IN GERMANY FOR:
    Syntrion® GmbH, 75365 Calw, Germany

  • PRINCIPAL DISPLAY PANEL - 90 Tablet Carton

    S Syntrion®

    SyAllgen

    For airborne allergies,
    contact allergies
    and neurodermatitis

    Homeopathic Medicine

    Available through
    practitioners only

    90 Tablets

    PRINCIPAL DISPLAY PANEL - 90 Tablet Carton
  • INGREDIENTS AND APPEARANCE
    SYALLGEN 
    penicillium glabrum tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10424-156
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Penicillium Glabrum (UNII: 2IN23YUE0I) (Penicillium Glabrum - UNII:2IN23YUE0I) Penicillium Glabrum4 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    powdered cellulose (UNII: SMD1X3XO9M)  
    lactose (UNII: J2B2A4N98G)  
    magnesium stearate (UNII: 70097M6I30)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUND (planar on both sides, and with facet) Size7mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10424-156-401 in 1 CARTON
    190 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC05/18/2006
    Labeler - Syntrion GmbH (331883145)
    Establishment
    NameAddressID/FEIBusiness Operations
    Syntrion GmbH331883145MANUFACTURE
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