Label: PLEO OKU- okoubaka aubrevillei bark 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 30, 2009

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  • SPL UNCLASSIFIED SECTION

    Homeopathic
    Antidiarrheal
    Medicine

    1 fl oz
    (30 mL)

  • Indications

    For temporary relief of acute diarrhea.

  • INGREDIENTS

    30 mL Okoubaka aubrevillei 2X in a base of purified water, ethanol (70%).

  • Tamper Evident

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

  • DOSAGE

    Acute

    5 drops, every ½ to 1 hour;

    Chronic

    5 drops, 1-3 times daily.

  • WARNING

    lf symptoms persist more than a few days, contact a licensed practitioner. As with any other 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.12/2007

  • PRINCIPAL DISPLAY PANEL - 30 mL Label

    Pleo™ Oku DROPS 2X

    Homeopathic Antidiarrheal Medicine

    Indications: For temporary relief of acute diarrhea.

    1 fl oz (30 mL)

    DOSAGE: Acute: 5 drops every ½ to 1 hour; Chronic: 5 drops, 1–3 times daily. WARNING:
    If symptoms persist more than a few days, contact a licensed practitioner. As with any other
    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. Protect from light and heat. TAMPER EVIDENT: Do not use this product if
    tamper-evident seal on base of bottle cap is missing or broken. INGREDIENTS: 30 mL
    contains: Okoubaka aubrevillei 2X in a base of purified water, ethanol (70 %). Rev. 06/2009

    Principal Display Panel - 30 mL Label
  • INGREDIENTS AND APPEARANCE
    PLEO OKU 
    okoubaka aubrevillei bark solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60681-2401
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OKOUBAKA AUBREVILLEI BARK (UNII: MK2074187Z) (OKOUBAKA AUBREVILLEI BARK - UNII:MK2074187Z) OKOUBAKA AUBREVILLEI BARK2 [hp_X]  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    alcohol (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60681-2401-31 in 1 CARTON
    130 mL in 1 BOTTLE, DROPPER
    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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