Label: FIRMUS- 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 November 2, 2015

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  • Indications

    For relief of chronic joint and membrane inflammation.

  • Ingredients

    255 mg Bacillus firmus 6X in a base of lactose and beet oil.

  • Dosage

    1-2 capsules per week, taken at least 1 hour before eating.

  • 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. Protect from light and heat.

    Tamper Evident

    Do not use product if tamper evident strip is broken or removed from base of cap. To report adverse events, contact BioResource at 707/664-9023 or bioresource2@prodigy.net

  • SPL UNCLASSIFIED SECTION

    Distributed By:
    BioResource Inc.
    Cotati CA 94931

  • PRINCIPAL DISPLAY PANEL - 10 Capsule Bottle Label

    SanPharma™
    Firmus Capsules 6X

    Homeopathic Medicine

    RX

    For joint and membrane inflammation

    10 CAPSULES

    SanPharma ™

    Principal Display Panel - 10 Capsule Bottle Label
  • INGREDIENTS AND APPEARANCE
    FIRMUS 
    bacillus firmus capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54256-008
    Route of AdministrationORAL
    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)  
    Beet (UNII: N487KM8COK)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeCAPSULESize15mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54256-008-0110 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC10/10/2015
    Labeler - BioResource Inc. (017532917)
    Establishment
    NameAddressID/FEIBusiness Operations
    RubiePharm Arzneimittel GmbH313767774MANUFACTURE(54256-008)
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