Label: PLEO FORT- penicillium roqueforti 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 Digestive Aid Medicine

    20 TABLETS

  • Indications

    For temporary relief of digestive symptoms such as fullness, pressure, or "gas" that occurs after eating.

  • INGREDIENTS

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

  • DOSAGE

    1–3 tablets daily, either two hours before breakfast or at bedtime.

  • 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 from your health care practitioner 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 or if imprinted security strip on carton is torn.

    Lot #:

  • SPL UNCLASSIFIED SECTION

    Made in Germany.

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

    Manufactured by:
    Sanum-Kehlbeck
    GmbH & Co. KG

    Rev. 12/2006

  • PRINCIPAL DISPLAY PANEL - 20 Tablets Carton

    Pleo™ Fort
    TABLETS 5X

    Homeopathic
    Digestive Aid
    Medicine

    lndications: For temporary
    relief of digestive symptoms such
    as fullness, pressure, or "gas" that
    occurs after eating.

    ORIGINAL ENDERLEIN

    20 TABLETS

    Principal Display Panel - 20 Tablets Carton
  • INGREDIENTS AND APPEARANCE
    PLEO FORT 
    penicillium roqueforti tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60681-1102
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    penicillium roqueforti (UNII: 7ORP6R724L) (penicillium roqueforti - UNII:7ORP6R724L) penicillium roqueforti5 [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:60681-1102-11 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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