Label: PLEO NOT- penicillium chrysogenum var. chrysogenum 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 October 12, 2009

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  • SPL UNCLASSIFIED SECTION

    Homeopathic Fever Reducer/Cough Suppressant/Decongestant Medicine

    The original SANUM™ brand remedies

    20 TABLETS

  • Indications

    For temporary relief of coughs, fever and congestion due to colds and minor respiratory infections.

  • INGREDIENTS

    1 tablet contains 250 mg Penicillium chrysogenum 5X in a base of lactose, potato starch, magnesium stearate.

  • DOSAGE

    1–3 x daily1 tablet.

  • WARNING

    If symptoms persist more than a few days, contact a licensed practitioner. As with any drug, if you are pregnant or nursing a baby, seek the advice of a health care professional before taking this product.

    Keep this and all medications out of the reach of children. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

  • STORAGE AND HANDLING

    Protect from light and heat.

  • Tamper Evident

    Do not use this product if imprinted inner blister pack is broken.

    Lot #:

    Exp.:

  • SPL UNCLASSIFIED SECTION

    Made in Germany

    Manufactured by:
    SANUM-Kehlbeck GmbH & Co. KG,
    Hoya, Germany

    Distributed by:
    SANUM USA Corp.,
    1465 Slater Road, Ferndale, WA 98248

    Rev. 06/2009

  • PRINCIPAL DISPLAY PANEL - 20 Tablets Carton

    Pleo® Not
    TABLETS 5X

    Homeopathic
    Fever Reducer/
    Cough Suppressant/
    Decongestant
    Medicine

    The original
    SANUM™
    brand remedies

    lndications: For temporary
    relief of coughs, fever and
    congestion due to colds and minor
    respiratory infections.

    ORIGINAL ENDERLEIN

    20 TABLETS

    Principal Display Panel - 20 Tablets Carton
  • INGREDIENTS AND APPEARANCE
    PLEO NOT 
    penicillium chrysogenum var. chrysogenum tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60681-2302
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    penicillium chrysogenum var. chrysogenum (UNII: 3Y1PE1GCIG) (aspergillus niger var. niger - UNII:9IOA40ANG6) penicillium chrysogenum var. chrysogenum5 [HP_X]
    Inactive Ingredients
    Ingredient NameStrength
    lactose (UNII: J2B2A4N98G)  
    Starch, Potato (UNII: 8I089SAH3T)  
    Magnesium Stearate (UNII: 70097M6I30)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize4mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60681-2302-11 in 1 CARTON
    120 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved homeopathic03/19/1996
    Labeler - Sanum Kehlbeck GmbH & Co. KG (318386133)
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