Label: PLEO ART U- brevibacterium stationis 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 March 7, 2012

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  • SPL UNCLASSIFIED SECTION

    Homeopathic Medicine

    0.34 fl oz
    (10 mL)

  • Indications

    To temporarily restore mental alertness during periods of fatigue

  • INGREDIENTS

    10 mL Corynebacterium sp. 6X in a base of purified water.

  • Tamper Evident

    Do not use this product if the plastic band at base of bottle cup is broken.

  • DOSAGE

    1–3 × weekly 2–5 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 immediataly.

  • 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. 8/2001

  • PRINCIPAL DISPLAY PANEL - 10 mL Bottle, Dropper Carton

    Pleo® Art
    "U"
    DROPS 6X

    Homeopathic
    Medicine

    The original
    SANUM®
    brand remedies

    Indications: To
    temporarily restore
    mental alertness
    during periods
    of fatigue.

    0.34 fl oz
    (10 mL)

    PRINCIPAL DISPLAY PANEL - 10 mL Bottle, Dropper Carton
  • INGREDIENTS AND APPEARANCE
    PLEO ART U 
    brevibacterium stationis solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60681-0401
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Brevibacterium Stationis (UNII: 118V62TZ38) (Brevibacterium Stationis - UNII:118V62TZ38) Brevibacterium Stationis6 [hp_X]  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60681-0401-11 in 1 CARTON
    110 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC02/19/1997
    Labeler - Sanum Kehlbeck GmbH & Co. KG (318386133)
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