Label: PLEO UT- bacillus subtilis capsule

  • 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 8, 2009

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  • SPL UNCLASSIFIED SECTION

    Homeopathic Analgesic Medicine

    5 CAPSULES

  • Indications

    For temporary pain relief of swollen lymph glands.

  • INGREDIENTS

    1 capsule contains 330 mg Bacillus subtilis 4X in a base of lactose.

  • OTHER COMPONENTS

    Capsule shells consist of Hypromellose (HPMC).

  • DOSAGE

    1–2 capsules weekly, one capsule either before breakfast or at bedtime.

  • 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 taking 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 shrink-wrap is missing from the carton or the imprinted blister foil 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

    Rev. 12/2004

  • PRINCIPAL DISPLAY PANEL - 5 Capsules Carton

    Pleo™ Ut
    CAPSULES 4X

    Homeopathic
    Analgesic Medicine

    Indications: For temporary pain
    relief of swollen lymph glands.

    5 CAPSULES

    Principal Display Panel - 5 Capsules Carton
  • INGREDIENTS AND APPEARANCE
    PLEO UT 
    bacillus subtilis capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60681-5302
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    bacillus subtilis (UNII: 8CF93KW41W) (bacillus subtilis - UNII:8CF93KW41W) bacillus subtilis4 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    lactose (UNII: J2B2A4N98G)  
    hypromellose (UNII: 3NXW29V3WO)  
    Product Characteristics
    ColorYELLOWScoreno score
    ShapeCAPSULESize19mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60681-5302-21 in 1 CARTON
    15 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved homeopathic03/19/1996
    Labeler - Sanum Kehlbeck GmbH & Co. KG (318386133)
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