Label: PLEO REC- bacillus firmus 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 Fever Reducer Medicine

    5 CAPSULES

  • Indications

    For temporary relief of fever and minor inflammation.

  • INGREDIENTS

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

  • OTHER COMPONENTS

    Capsule shells consist of Hypromellose (HPMC).

  • DOSAGE

    1–2 times 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 - Capsule Carton

    Pleo™ Rec
    CAPSULES 4X

    Homeopathic
    Fever Reducer Medicine

    Indications: For temporary relief
    of fever and minor inflammation.

    5 CAPSULES

    PRINCIPAL DISPLAY PANEL - Capsule Carton
  • INGREDIENTS AND APPEARANCE
    PLEO REC 
    bacillus firmus capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60681-3102
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    bacillus firmus (UNII: D6U864H4DT) (bacillus firmus - UNII:D6U864H4DT) bacillus firmus4 [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:60681-3102-21 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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