Label: HYDRASTIS CANADENSIS- goldenseal pellet

  • NDC Code(s): 68428-428-03, 68428-428-05, 68428-428-06, 68428-428-11, view more
    68428-428-12
  • 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 October 19, 2023

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  • ACTIVE INGREDIENTS

    HYDRASTIS

  • USES

    To relieve the symptoms of sinuses.

  • KEEP OUT OF REACH OF CHILDREN

    Keep this and all medicines out of reach of children.

  • INDICATIONS

    Indications:

    HYDRASTIS   Sinuses

  • STOP USE AND ASK DOCTOR

    If symptoms persist/worsen or if pregnant/nursing, stop use and consult your practitioner.

  • DIRECTIONS

    Adults: Dissolve 3 to 5 under the tongue three times a day or as directed by Lic. Practitioner. Take at greater intervals as condition subsides.  Children: Dissolve 3 to 5 under the tongue three times a day or as directed by Lic. Practitioner. Take at greater intervals as condition subsides.

  • INACTIVE INGREDIENTS

    Sucrose/Lactose

  • PRINCIPAL DISPLAY PANEL

    The OTC potency range of HYDRASTIS is 5x–30x, 3c–30c, 200c, 1m, 10m, 50m, and CM.
    Hydrastis2023
    Availability is subject to change.

    All WHP single remedies are made to order; thus, the labels are printed on the same label stock as the orders are filled.

    ‘Bottle Size’ and ‘Potency’ vary on the label depending on customer choice.

    Standard bottle sizes for pellet-form remedies are 2 dram, 4 dram, 1 ounce, 2 ounce, and 4 ounce.

  • INGREDIENTS AND APPEARANCE
    HYDRASTIS CANADENSIS 
    goldenseal pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68428-428
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL30 [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:68428-428-0375 in 1 VIAL, GLASS; Type 0: Not a Combination Product02/03/2010
    2NDC:68428-428-05150 in 1 VIAL, GLASS; Type 0: Not a Combination Product02/03/2010
    3NDC:68428-428-11300 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product02/03/2010
    4NDC:68428-428-12600 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product02/03/2010
    5NDC:68428-428-061200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product02/03/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic02/03/2010
    Labeler - Washington Homeopathic Products (084929389)
    Establishment
    NameAddressID/FEIBusiness Operations
    Washington Homeopathic Products084929389manufacture(68428-428)
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