Label: PLEO MUSCAR- amanita muscaria whole 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 June 26, 2012

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  • PURPOSE

    Homeopathic Medicine

  • Indications

    For pain associated with muscle cramps and migraine headaches, for occasional irritability and the symptoms of irritable "bowel syndrome".

  • ACTIVE INGREDIENT

    INGREDIENTS

    10 mL Amanita muscaria 6X in a base of purified water and alcohol 50% by volume.

  • Tamper Evident

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

  • 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.

  • 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®
    Muscar
    DROPS 6X

    Homeopathic
    Medicine

    The original
    SANUM®

    brand remedies

    Indications: For pain
    associated with muscle
    cramps and migraine
    headaches, for
    occasional irritability
    and the symptoms of
    irritable "bowel
    syndrome".

    0.34 fl oz
    (10 mL)

    Principal Display Panel - 10 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    PLEO MUSCAR 
    amanita muscaria whole liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60681-0801
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AMANITA MUSCARIA WHOLE (UNII: RQ7YY49K9Q) (AMANITA MUSCARIA WHOLE - UNII:RQ7YY49K9Q) AMANITA MUSCARIA WHOLE6 [hp_X]  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60681-0801-21 in 1 CARTON
    110 mL in 1 BOTTLE
    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(60681-0801)
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