Label: APO-RHEUM- arnica montana root, bryonia dioica root, colchicum autumnale bulb, solanum dulcamara top, pseudognaphalium obtusifolium, guaiacum officinale resin, and taraxacum officinale whole solution/ drops

  • NDC Code(s): 59469-134-10
  • Packager: PEKANA Naturheilmittel GmbH
  • 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 December 5, 2022

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  • ACTIVE INGREDIENT

    Ingredients:
    Arnica montana12X
    Bryonia cretica4X
    Colchium autumnale12X
    Pseudognaphalium obtusifolium (Gnaphalium polycephalum)4X
    Guajacum6X
    Solanum dulcamara12X
    Taraxacum officinale12X

    Selected ingredients prepared by spagyric processes.

  • INACTIVE INGREDIENT

    Contains 18% alcohol by volume.

  • Indications

    For relief of minor joint pain. Application of this homeopathic remedy for the designated usage is exclusively based on homeopathic experience. With severe forms of this disease, a clinically proven therapy is indicated.

  • Dosage

    Unless otherwise prescribed, adults take 15-20 drops, 3 times per day. For pediatric dosages, consult your practitioner.

  • Warning

    If symptoms persist, contact a licensed practitioner. If you have known sensitivity to any of the ingredients, please consult your licensed practitioner before use. If you are pregnant or nursing a baby, seek the advice of a health care professional before use.

    Keep out of the reach of children.

    Protect from light and heat.

    Tamper Evident

    Do not use this product if tamper evident strip is broken or removed from base of cap.

  • QUESTIONS

    To report adverse events, contact BioResource at 321B Blodgett Street, Cotati, CA 94931

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    BioResource Inc.
    Cotati, CA 94931

    Manufactured by:
    PEKANA®     GmbH
    D-88353 Kisslegg

  • PRINCIPAL DISPLAY PANEL - 50 ml Bottle Box

    apo-RHEUM™
    Oral Drops

    Homeopathic Medicine

    For relief of
    minor joint pain

    1.7 FL OZ
    (50 ml)

    PEKANA®

    PRINCIPAL DISPLAY PANEL - 50 ml Bottle Box
  • INGREDIENTS AND APPEARANCE
    APO-RHEUM 
    arnica montana root, bryonia dioica root, colchicum autumnale bulb, solanum dulcamara top, pseudognaphalium obtusifolium, guaiacum officinale resin, and taraxacum officinale whole solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59469-134
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARNICA MONTANA ROOT (UNII: MUE8Y11327) (ARNICA MONTANA ROOT - UNII:MUE8Y11327) ARNICA MONTANA ROOT12 [hp_X]  in 50 mL
    BRYONIA DIOICA ROOT (UNII: 53UB5FH7CX) (BRYONIA DIOICA ROOT - UNII:53UB5FH7CX) BRYONIA DIOICA ROOT4 [hp_X]  in 50 mL
    COLCHICUM AUTUMNALE BULB (UNII: 993QHL78E6) (COLCHICUM AUTUMNALE BULB - UNII:993QHL78E6) COLCHICUM AUTUMNALE BULB12 [hp_X]  in 50 mL
    SOLANUM DULCAMARA TOP (UNII: KPS1B1162N) (SOLANUM DULCAMARA TOP - UNII:KPS1B1162N) SOLANUM DULCAMARA TOP12 [hp_X]  in 50 mL
    PSEUDOGNAPHALIUM OBTUSIFOLIUM WHOLE (UNII: 36XQ854NWW) (PSEUDOGNAPHALIUM OBTUSIFOLIUM WHOLE - UNII:36XQ854NWW) PSEUDOGNAPHALIUM OBTUSIFOLIUM WHOLE4 [hp_X]  in 50 mL
    GUAIACUM OFFICINALE RESIN (UNII: N0K2Z502R6) (GUAIACUM OFFICINALE RESIN - UNII:N0K2Z502R6) GUAIACUM OFFICINALE RESIN6 [hp_X]  in 50 mL
    TARAXACUM OFFICINALE WHOLE (UNII: 7C42E2D7B0) (TARAXACUM OFFICINALE WHOLE - UNII:7C42E2D7B0) TARAXACUM OFFICINALE WHOLE12 [hp_X]  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Alcohol (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59469-134-101 in 1 BOX12/11/2008
    150 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC12/11/2008
    Labeler - PEKANA Naturheilmittel GmbH (320344542)
    Establishment
    NameAddressID/FEIBusiness Operations
    PEKANA Naturheilmittel GmbH320344542MANUFACTURE(59469-134)
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