Label: PLEO CUP- copper gluconate solution/ drops

  • 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 7, 2011

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  • PURPOSE

    Homeopathic Medicine

  • Indications

    For nausea

  • INGREDIENTS

    30 mL contains cuprous gluconate 3X in a base of purified water, ethanol (20%).

  • Tamper Evident

    Do not use this product if tamper-evident seal on base of bottle cap is missing or broken.

  • DOSAGE

    In case of acute conditions every half to one hour, not more than 6 × daily each 5 drops. In case of chronic forms 1-3 × daily 5 drops.

  • 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 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

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

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

    Rev. 04/2010

  • PRINCIPAL DISPLAY PANEL - 30 mL Label

    Pleo® Cup
    DROPS 3X

    Homeopathic
    Medicine

    The original
    SANUM®
    brand remedies

    Indications:
    For nausea

    1 fl oz
    (30 mL)

    Principal Display Panel - 30 mL Label
  • INGREDIENTS AND APPEARANCE
    PLEO CUP 
    copper gluconate solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60681-1071
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    copper gluconate (UNII: RV823G6G67) (copper - UNII:789U1901C5) copper gluconate3 [hp_X]  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    alcohol (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60681-1071-31 in 1 CARTON
    130 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved homeopathic08/12/1998
    Labeler - Sanum Kehlbeck GmbH & Co. KG (318386133)
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