Label: PLEO SANUVIS- lactic acid, l- 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 May 30, 2013

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  • PURPOSE

    Homeopathic Digestive Aid Lactic Acid

    80 Tablets

  • Indications

    Digestive aid for pre and post operative support.

  • INGREDIENTS

    One tablet contains 50 mg Acidum L(+)-lacticum 4X, 50 mg Acidum L(+)-lacticum 6X , 50 mg Acidum L(+)-lacticum 12X, 50 mg Acidum L(+)-lacticum 30X, 50 mg Acidum L(+)-lacticum 200X in a base of lactose, potato starch, magnesium stearate.

  • Tamper Evident

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

  • DOSAGE

    1-3x daily 1-2 tablet.

  • 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 other medications out of the reach of children. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

    Protect fom 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
    Hoya, Germany

    Rev. 10/2012

  • PRINCIPAL DISPLAY PANEL - 80 Tablet Carton

    Pleo® Sanuvis
    TABLETS

    Homeopathic
    Digestive Aid
    Lactic Acid

    The original
    SANUM®
    brand remedies

    Indications:
    Digestive aid for
    pre and post
    operative support.

    80 TABLETS

    PRINCIPAL DISPLAY PANEL - 80 Tablet Carton
  • INGREDIENTS AND APPEARANCE
    PLEO SANUVIS 
    lactic acid, l- tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60681-6303
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    lactic acid, l- (UNII: F9S9FFU82N) (lactic acid, l- - UNII:F9S9FFU82N) lactic acid, l-200 [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:60681-6303-11 in 1 CARTON
    180 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved homeopathic06/15/2010
    Labeler - Sanum Kehlbeck GmbH & Co. KG (318386133)
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