Label: PLEO STROPH- strophanthus hispidus 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 November 25, 2009

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  • SPL UNCLASSIFIED SECTION

    Homeopathic Preparation for a Healthy Heart

    80 TABLETS

  • ACTIVE INGREDIENTS

    Each tablet contains 250 mg Strophanthus g. 4X.

  • INACTIVE INGREDIENTS

    lactose, potato starch, magnesium stearate.

  • Tamper Evident

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

  • DOSAGE

    Acute

    1 tablet every half to full hour up to a max. of 12 times daily.

    Chronic

    2 tablets daily.

  • WARNING

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

  • 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. 08/2005

  • PRINCIPAL DISPLAY PANEL - 80 Tablet Carton

    Pleo™ Stroph
    TABLETS 4X

    Homeopathic
    Preparation for a
    Healthy Heart

    80 TABLETS

    Principal Display Panel - 80 Tablet Carton
  • INGREDIENTS AND APPEARANCE
    PLEO STROPH 
    strophanthus hispidus tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60681-9012
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    strophanthus hispidus (UNII: MO892VI77K) (strophanthus hispidus - UNII:MO892VI77K) strophanthus hispidus4 [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:60681-9012-11 in 1 CARTON
    180 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved homeopathic02/21/2006
    Labeler - Sanum Kehlbeck GmbH & Co. KG (318386133)
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