Label: PLEO FORT- penicillium roqueforti 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 October 20, 2011

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  • PURPOSE

    Oral Homeopathic Medicine

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

  • INDICATIONS

    For temporary relief of digestive symptoms such as fullness, pressure or "gas" that occur after eating.

  • DIRECTIONS FOR USE

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

  • DOSAGE

    1 - 3x weekly 1 sip

  • INGREDIENTS

    1 mL contains Penicillium roquefortii 5X, 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.

  • SPL UNCLASSIFIED SECTION

    Made in Germany

    Manufactured By:
    SANUM-Kehlbeck
    GmbH & Co. KG,
    Hoya, Germany

    Rev. 10/2002

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

  • PRINCIPAL DISPLAY PANEL - 10 Vial Carton

    1105-1

    Pleo® Fort
    PORTABLE SIPS 5X

    Oral Homeopathic Medicine

    The original
    SANUM®
    brand remedies

    INDICATIONS: For temporary relief of di-
    gestive symptoms such as fullness, pres-
    sure or "gas" that occur after eating.

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

    DOSAGE: 1 - 3x weekly 1 sip

    INGREDIENTS: 1 mL contains Penicillium
    roquefortii 5X, in a base of purified saline
    solution.

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

    ORIGINAL ENDERLEIN

    convenient, disposable
    single dose containers

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

    Rev. 10/2002

    300INSXSE10US912

    PRINCIPAL DISPLAY PANEL - 10 Vial Carton
  • INGREDIENTS AND APPEARANCE
    PLEO FORT 
    penicillium roqueforti liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60681-1105
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    penicillium roqueforti (UNII: 7ORP6R724L) (penicillium roqueforti - UNII:7ORP6R724L) penicillium roqueforti5 [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:60681-1105-110 in 1 CARTON
    11 mL in 1 VIAL, GLASS
    2NDC:60681-1105-250 in 1 CARTON
    21 mL in 1 VIAL, GLASS
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC01/19/1998
    Labeler - Sanum Kehlbeck GmbH & Co. KG (318386133)
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