Label: PLEO NOTA-QUENT- penicillium chrysogenum var. chrysogenum and penicillium glabrum 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 April 13, 2012

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  • PURPOSE

    Homeopathic Medicine

    0.34 fl oz
    (10 mL)

  • Indications

    For temporary relief of bronchial and sinus congestion with fever and coughing due to colds and minor respiratory infections.

  • DOSAGE

    5-10 drops, once daily, before mealtime.

  • 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 from light and heat.

  • ACTIVE INGREDIENT

    INGREDIENTS

    10 mL contain 5 mL Penicillium chrysogenum 5X, 5 mL Penicillium glabrum 5X in a base of purified water.

  • Tamper Evident

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

  • SPL UNCLASSIFIED SECTION

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

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

  • PRINCIPAL DISPLAY PANEL - 10 mL Bottle Carton

    Pleo®
    Nota-Quent

    DROPS 5X
    Homeopathic
    Medicine

    The original
    SANUM®
    brand remedies

    Indications:
    For temporary relief of
    bronchial and
    sinus congestion with
    fever and coughing due
    to colds and minor
    respiratory infections.

    ORIGINAL ENDERLEIN

    0.34 fl oz
    (10 mL)

    Principal Display Panel - 10 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    PLEO NOTA-QUENT 
    penicillium chrysogenum var. chrysogenum and penicillium glabrum liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60681-0031
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM (UNII: 3Y1PE1GCIG) (PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM - UNII:3Y1PE1GCIG) PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM5 [hp_X]  in 1 mL
    PENICILLIUM GLABRUM (UNII: 2IN23YUE0I) (PENICILLIUM GLABRUM - UNII:2IN23YUE0I) PENICILLIUM GLABRUM5 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60681-0031-11 in 1 CARTON
    110 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC04/15/2012
    Labeler - Sanum-Kehlbeck GmbH & Co. KG (318386133)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sanum-Kehlbeck GmbH & Co. KG318386133MANUFACTURE
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