Label: VISCUM- viscum album fruiting top solution/ drops

  • NDC Code(s): 59469-322-10
  • Packager: PEKANA Natuheilmittel 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:
    Viscum album3X

    Prepared by spagyric processes.

  • INACTIVE INGREDIENT

    Contains 19% alcohol by volume.

  • Indications

    For relief of minor dizziness and nausea. 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

    VISCUM™

    Oral Drops

    Homeopathic Medicine

    For relief of minor
    dizziness and nausea

    1.7 FL OZ
    (50 ml)

    PEKANA®

    PRINCIPAL DISPLAY PANEL - 50 ml Bottle Box
  • INGREDIENTS AND APPEARANCE
    VISCUM 
    viscum album fruiting top solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59469-322
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    VISCUM ALBUM FRUITING TOP (UNII: BK9092J5MP) (VISCUM ALBUM FRUITING TOP - UNII:BK9092J5MP) VISCUM ALBUM FRUITING TOP3 [hp_X]  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59469-322-101 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 Natuheilmittel GmbH (320344542)
    Establishment
    NameAddressID/FEIBusiness Operations
    PEKANA Natuheilmittel GmbH320344542MANUFACTURE(59469-322)
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