Label: PLEO REC- bacillus firmus suppository

  • 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 14, 2009

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  • SPL UNCLASSIFIED SECTION

    Homeopathic Fever Reducer Medicine

    10 SUPPOSITORIES

  • Indications

    For temporary relief of fever and minor inflammation.

  • ACTIVE INGREDIENT PER DOSE

    0.2 g Bacillus firmus 6X.

  • Inactive ingredients

    hydrogenated palm kernel glycerides, lactose.

  • DOSAGE

    1–3 times weekly, insert one suppository rectally 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 using this product.

    Keep this and all other medications out of the reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

  • STORAGE AND HANDLING

    Protect from light and heat.

  • Tamper Evident

    Use this product only if inner blister pack is intact.

  • 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. 10/2002

  • PRINCIPAL DISPLAY PANEL - 10 Suppository Carton

    Pleo™ Rec
    SUPPOSITORIES 6X

    Homeopathic Fever
    Reducer Medicine

    Indications: For temporary relief
    of fever and minor inflammation.

    10 SUPPOSITORIES

    Principal Display Panel - 10 Suppository Carton
  • INGREDIENTS AND APPEARANCE
    PLEO REC 
    bacillus firmus suppository
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60681-3104
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    bacillus firmus (UNII: D6U864H4DT) (bacillus firmus - UNII:D6U864H4DT) bacillus firmus6 [HP_X]
    Inactive Ingredients
    Ingredient NameStrength
    lactose (UNII: J2B2A4N98G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60681-3104-11 in 1 CARTON
    110 in 1 DOSE 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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