Label: PLEO MUSCAR- amanita muscaria var. muscaria 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 3, 2010

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  • SPL UNCLASSIFIED SECTION

    Oral Homeopathic Medicine

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

  • INDICATIONS

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

  • DIRECTIONS FOR USE

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

  • DOSAGE

    acute: 1-2 ml 3 times daily. chronic diseases: 1-2 times daily.

  • INGREDIENTS

    1 mL contains Amanita muscaria e thallo 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 glass vial is broken.

  • 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. 03/2010

  • PRINCIPAL DISPLAY PANEL - 1 mL Vial Carton

    0802-2

    Pleo® Muscar

    PORTABLE SIPS 6X

    Oral 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".

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

    DOSAGE: acute: 1-2 ml 3 times daily.
    chronic diseases: 1-2 times daily.

    INGREDIENTS: 1 mL contains Amanita
    muscaria e thallo 6X in a base of purified
    saline solution.

    convenient, disposable
    single dose containers

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

    Rev. 03/2010

    PRINCIPAL DISPLAY PANEL - 1 mL Vial Carton
  • INGREDIENTS AND APPEARANCE
    PLEO MUSCAR 
    amanita muscaria var. muscaria liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60681-0802
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    amanita muscaria var. muscaria (UNII: DIF093I037) (amanita muscaria var. muscaria - UNII:DIF093I037) amanita muscaria var. muscaria6 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    sodium chloride (UNII: 451W47IQ8X)  
    water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60681-0802-110 in 1 CARTON
    11 mL in 1 VIAL, GLASS
    2NDC:60681-0802-250 in 1 CARTON
    21 mL in 1 VIAL, GLASS
    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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