Label: HELLEBORUS NIGER- helleborus niger root pellet

  • NDC Code(s): 71919-817-01
  • Packager: Washington Homeopathic Products
  • 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 November 7, 2023

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  • ACTIVE INGREDIENTS

    Helleborus niger 30C

  • USES

    Indicated for Pale skin.

  • KEEP OUT OF REACH OF CHILDREN

    As with all medications, keep out of reach of children.

  • INDICATIONS

    Helleborus niger indicated for Pale Skin.

  • STOP USE AND ASK DOCTOR

    If symptoms persist or recur, discontinue use. If pregnant or nursing, consult a licensed practitioner before using this product.

  • DIRECTIONS

    (Adults or Children): Dissolve 3 to 5 pellets under tongue 3 times a day or as directed by a licensed practitioner. Take at greater intervals as condition subsides.

  • INACTIVE INGREDIENTS

    Sucrose/Lactose

  • PRINCIPAL DISPLAY PANEL

    Helleborus kit refill 30c

  • INGREDIENTS AND APPEARANCE
    HELLEBORUS NIGER 
    helleborus niger root pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71919-817
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HELLEBORUS NIGER ROOT (UNII: 608DGJ6815) (HELLEBORUS NIGER ROOT - UNII:608DGJ6815) HELLEBORUS NIGER ROOT30 [hp_C]
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    LACTOSE (UNII: J2B2A4N98G)  
    Product Characteristics
    Colorwhite (white) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71919-817-01350 in 1 VIAL, GLASS; Type 0: Not a Combination Product11/07/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic11/07/2023
    Labeler - Washington Homeopathic Products (084929389)
    Establishment
    NameAddressID/FEIBusiness Operations
    Washington Homeopathic Products084929389manufacture(71919-817)
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