Label: DEFAETON- peumus boldus leaf, dioscorea villosa tuber, strychnos ignatii seed, cynara scolymus whole, fumaria officinalis whole, frangula alnus bark, and rheum officinale root solution/ drops

  • NDC Code(s): 59469-133-10, 59469-133-40
  • 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 January 11, 2023

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  • ACTIVE INGREDIENT

    Ingredients:
    Cynara scloymus12X
    Dioscorea villosa4X
    Fumaria officinalis6X
    Strychnos ignatii (Ignatia)6X
    Peumus boldus (Boldo)6X
    Rhamnus frangula8X
    Rheum8X

    Selected ingredients prepared by spagyric processes.

  • INACTIVE INGREDIENT

    Contains 19% alcohol by volume.

  • Indications

    For relief of occasional constipation. 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 20 drops, 4 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 - 100 ml Bottle Box

    DEFAETON™
    Oral Drops

    Homeopathic Medicine

    For relief of
    occasional constipation

    3.34 FL OZ
    (100 ml)

    PEKANA®

    PRINCIPAL DISPLAY PANEL - 100 ml Bottle Box
  • INGREDIENTS AND APPEARANCE
    DEFAETON 
    peumus boldus leaf, dioscorea villosa tuber, strychnos ignatii seed, cynara scolymus whole, fumaria officinalis whole, frangula alnus bark, and rheum officinale root solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59469-133
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PEUMUS BOLDUS LEAF (UNII: Q4EWM09M3O) (PEUMUS BOLDUS LEAF - UNII:Q4EWM09M3O) PEUMUS BOLDUS LEAF6 [hp_X]  in 50 mL
    DIOSCOREA VILLOSA TUBER (UNII: IWY3IWX2G8) (DIOSCOREA VILLOSA TUBER - UNII:IWY3IWX2G8) DIOSCOREA VILLOSA TUBER4 [hp_X]  in 50 mL
    STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED6 [hp_X]  in 50 mL
    CYNARA SCOLYMUS WHOLE (UNII: 9N3437ZUU0) (CYNARA SCOLYMUS WHOLE - UNII:9N3437ZUU0) CYNARA SCOLYMUS WHOLE12 [hp_X]  in 50 mL
    FUMARIA OFFICINALIS WHOLE (UNII: DM87NN227Z) (FUMARIA OFFICINALIS WHOLE - UNII:DM87NN227Z) FUMARIA OFFICINALIS WHOLE6 [hp_X]  in 50 mL
    FRANGULA ALNUS BARK (UNII: S2D77IH61R) (FRANGULA ALNUS BARK - UNII:S2D77IH61R) FRANGULA ALNUS BARK8 [hp_X]  in 50 mL
    RHEUM OFFICINALE ROOT (UNII: A47JP5ZG9M) (RHEUM OFFICINALE ROOT - UNII:A47JP5ZG9M) RHEUM OFFICINALE ROOT8 [hp_X]  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59469-133-101 in 1 BOX12/11/2008
    150 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    2NDC:59469-133-401 in 1 BOX05/01/2017
    2100 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(59469-133)
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