Label: HELMIN- onion, artemisia abrotanum flowering top, artemisia cina pre-flowering top, cupric oxide, okoubaka aubrevillei bark, schoenocaulon officinale seed, and spigelia anthelmia solution/ drops

  • NDC Code(s): 59469-058-20
  • 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 June 24, 2019

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Ingredients:
    Allium cepa6X
    Artemisia abrotanum8X
    Artemisia cina12X
    Cuprum oxydatum nigrum12X
    Okoubaka aubrevillei4X
    Schoenocaulon officinale (Sabadilla)6X
    Spigelia anthelmia4X
  • INACTIVE INGREDIENT

    Selected ingredients prepared by spagyric processes.

    Contains 21% alcohol by volume.

  • Indications

    For relief of minor occasional digestive 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

    Manufactured by:
    PEKANA®
    GmbH
    D-88353 Kisslegg

    Distributed by:
    BioResource Inc.
    Cotati, CA 94931

  • PRINCIPAL DISPLAY PANEL - 50 ml Bottle Box

    HELMIN
    Oral Drops

    Homeopathic Medicine

    For relief of
    minor occasional
    digestive pain

    1.7 FL OZ
    (50 ml)

    PEKANA®

    PRINCIPAL DISPLAY PANEL - 50 ml Bottle Box
  • INGREDIENTS AND APPEARANCE
    HELMIN 
    onion, artemisia abrotanum flowering top, artemisia cina pre-flowering top, cupric oxide, okoubaka aubrevillei bark, schoenocaulon officinale seed, and spigelia anthelmia solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59469-058
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Onion (UNII: 492225Q21H) (Onion - UNII:492225Q21H) Onion6 [hp_X]  in 50 mL
    Artemisia abrotanum Flowering Top (UNII: QG07G580U0) (Artemisia abrotanum Flowering Top - UNII:QG07G580U0) Artemisia abrotanum Flowering Top8 [hp_X]  in 50 mL
    Artemisia cina Pre-Flowering Top (UNII: 28M1820ACT) (Artemisia Cina Pre-Flowering Top - UNII:28M1820ACT) Artemisia cina Pre-Flowering Top12 [hp_X]  in 50 mL
    Cupric Oxide (UNII: V1XJQ704R4) (Cupric Cation - UNII:8CBV67279L) Cupric Cation12 [hp_X]  in 50 mL
    Okoubaka aubrevillei Bark (UNII: MK2074187Z) (Okoubaka aubrevillei Bark - UNII:MK2074187Z) Okoubaka aubrevillei Bark4 [hp_X]  in 50 mL
    Schoenocaulon officinale Seed (UNII: 6NAF1689IO) (Schoenocaulon Officinale Seed - UNII:6NAF1689IO) Schoenocaulon officinale Seed6 [hp_X]  in 50 mL
    Spigelia Anthelmia (UNII: WYT05213GE) (Spigelia Anthelmia - UNII:WYT05213GE) Spigelia Anthelmia4 [hp_X]  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Alcohol (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59469-058-201 in 1 BOX04/12/2008
    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 HOMEOPATHIC04/12/2008
    Labeler - PEKANA Naturheilmittel GmbH (320344542)
    Establishment
    NameAddressID/FEIBusiness Operations
    PEKANA Naturheilmittel GmbH320344542MANUFACTURE(59469-058)