Label: PLEO OKU- okoubaka aubrevillei bark 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 July 6, 2012

If you are a consumer or patient please visit this version.

View All Sections
  • PURPOSE

    Homeopathic Antidiarrheal Medicine

  • Indications

    For temporary relief of acute diarrhea.

  • ACTIVE INGREDIENT

    INGREDIENTS

    One tablet contains 250 mg Okoubaka aubrevillei 2X in a base of lactose, potato starch, magnesium stearate.

  • Tamper Evident

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

  • DOSAGE

    Acute

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

    Chronic

    2 tablets daily.

  • WARNING

    lf 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 other 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

    Rev. 04/2012

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

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

  • PRINCIPAL DISPLAY PANEL - 80 Tablet Carton

    Pleo® Oku
    TABLETS 2X

    Homeopathic
    Antidiarrheal
    Medicine

    The original
    SANUM®

    brand remedies

    Indications: For temporary relief of
    acute diarrhea.

    80 TABLETS

    PRINCIPAL DISPLAY PANEL - 80 Tablet Carton
  • INGREDIENTS AND APPEARANCE
    PLEO OKU 
    okoubaka aubrevillei bark tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60681-2402
    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]
    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:60681-2402-28 in 1 CARTON
    110 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved homeopathic07/10/2012
    Labeler - Sanum-Kehlbeck GmbH & Co. KG (318386133)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sanum-Kehlbeck GmbH & Co. KG318386133MANUFACTURE(60681-2402)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!