Label: APO-OEDEM- horse chestnut, apocynum cannabinum root, convallaria majalis flowering top, helleborus niger root, thuja occidentalis leafy twig, sambucus nigra flowering top, filipendula ulmaria root, and corn silk solution/ drops

  • NDC Code(s): 59469-302-10
  • 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 June 18, 2019

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

  • ACTIVE INGREDIENT

    Ingredients:
    Aesculus hippocastanum4X
    Apocynum cannabinum3X
    Convallaria majalis12X
    Helleborus niger4X
    Sambucus nigra4X
    Filipendula ulmaria (Spiraea ulmaria)6X
    Stigmata maydis4X
    Thuja occidentalis6X

    Selected ingredients prepared by spagyric processes.

  • INACTIVE INGREDIENT

    Contains 26% alcohol by volume.

  • Indications

    For relief of minor swelling. 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-OEDEM™

    Oral Drops

    Homeopathic Medicine

    For relief of
    minor swelling

    1.7 FL OZ
    (50 ml)

    PEKANA®

    PRINCIPAL DISPLAY PANEL - 50 ml Bottle Box
  • INGREDIENTS AND APPEARANCE
    APO-OEDEM 
    horse chestnut, apocynum cannabinum root, convallaria majalis flowering top, helleborus niger root, thuja occidentalis leafy twig, sambucus nigra flowering top, filipendula ulmaria root, and corn silk solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59469-302
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Horse Chestnut (UNII: 3C18L6RJAZ) (Horse Chestnut - UNII:3C18L6RJAZ) Horse Chestnut4 [hp_X]  in 50 mL
    Apocynum cannabinum Root (UNII: 2F92409L9Z) (Apocynum Cannabinum Root - UNII:2F92409L9Z) Apocynum cannabinum Root3 [hp_X]  in 50 mL
    Convallaria majalis Flowering Top (UNII: 4G7VTP9FC4) (Convallaria Majalis Flowering Top - UNII:4G7VTP9FC4) Convallaria majalis Flowering Top12 [hp_X]  in 50 mL
    Helleborus niger Root (UNII: 608DGJ6815) (Helleborus Niger Root - UNII:608DGJ6815) Helleborus niger Root4 [hp_X]  in 50 mL
    Thuja occidentalis Leafy Twig (UNII: 1NT28V9397) (Thuja occidentalis Leafy Twig - UNII:1NT28V9397) Thuja occidentalis Leafy Twig6 [hp_X]  in 50 mL
    Sambucus nigra Flowering Top (UNII: CT03BSA18U) (Sambucus Nigra Flowering Top - UNII:CT03BSA18U) Sambucus nigra Flowering Top4 [hp_X]  in 50 mL
    Filipendula ulmaria Root (UNII: 997724QNDS) (Filipendula Ulmaria Root - UNII:997724QNDS) Filipendula ulmaria Root6 [hp_X]  in 50 mL
    Corn Silk (UNII: 7D3VB244UX) (Corn silk - UNII:7D3VB244UX) Corn Silk4 [hp_X]  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Alcohol (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59469-302-101 in 1 BOX06/24/2019
    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 HOMEOPATHIC06/24/2019
    Labeler - PEKANA Naturheilmittel Gmbh (320344542)
    Establishment
    NameAddressID/FEIBusiness Operations
    PEKANA Naturheilmittel Gmbh320344542MANUFACTURE(59469-302)