Label: PLEO ART U- brevibacterium stationis liquid

  • 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

    Oral Homeopathic Medicine

    50 doses, each 1 mL
    (.03 fl oz)

  • INDICATIONS

    To temporarily restore mental alertness during periods of fatigue.

  • DIRECTIONS FOR USE

    Snap off top portion of sipping container. Insert glass sipping straw.

  • DOSAGE

    1-2 × weekly 1 sip

  • INGREDIENTS

    1 mL contains Corynebacterium sp. 6X, in a base of purified saline solution.

  • 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.

    Protect from light and heat.

    Tamper Evident

    Do not use this product if the glass vial is broken or if imprinted security strip on carton is torn.

  • 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. 11/97

  • PRINCIPAL DISPLAY PANEL - 1 mL Vial Carton

    0205-1

    Pleo® Art "U"
    PORTABLE SIPS 6X

    Oral Homeopathic Medicine

    The Original
    SANUM™
    brand remedies

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

    DIRECTIONS FOR USE: Snap off top
    portion of sipping container. Insert glass
    sipping straw.

    DOSAGE: 1-2 × weekly 1 sip

    INGREDIENTS: 1 mL contains Coryne-
    bacterium sp. 6X, in a base of purified sa-
    line solution.

    Tamper Evident: Do not use this product
    if the glass vial is broken.

    convenient, disposable
    single dose containers

    10 doses, each 1 mL
    (.03 fl oz)

    Rev. 09/2009

    PRINCIPAL DISPLAY PANEL - 1 mL Vial Carton
  • INGREDIENTS AND APPEARANCE
    PLEO ART U 
    brevibacterium stationis liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60681-0205
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Brevibacterium stationis (UNII: 118V62TZ38) (Brevibacterium stationis - UNII:118V62TZ38) Brevibacterium stationis6 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    sodium chloride (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60681-0205-110 in 1 CARTON
    11 mL in 1 VIAL, GLASS
    2NDC:60681-0205-250 in 1 CARTON
    21 mL in 1 VIAL, GLASS
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC03/19/1997
    Labeler - Sanum Kehlbeck GmbH & Co. KG (318386133)
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