Label: SANGUINARIA CANADENSIS- sanguinaria canadensis root pellet

  • 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 16, 2023

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  • ACTIVE INGREDIENT

    Sanguinaria canadensis 200CK

    (**contains 0.443 mg of the active ingredient per pellet)

  • PURPOSE

  • INDICATIONS & USAGE

    Hot flashes with periodic headache*

  • WARNINGS

  • STOP USE

    Stop use and ask a doctor if symptoms persist for more than 3 days or worsen

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding ask a health professional before use

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • SPL UNCLASSIFIED SECTION

    Do not use if pellet dispenser seal is broken.
    Contains approx 80 pellets.
    How to dispense pellets? Turn tube upside down. Twist until 5 pellets are dispensed into cap. Carefully remove the cap and use it to pour pellets under the tongue.
    *CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.
    *C,K,CK, and X are homeopathic dilutions: see BoironUSA.com/info for details.

  • INACTIVE INGREDIENT

    lactose, sucrose

  • DOSAGE & ADMINISTRATION

    Adults and children: At the onset of symptoms, dissolve 5 pellets under the tongue 3 times a day until symptoms are relieved or as directed by a doctor.

  • QUESTIONS

    1-800-BOIRON-1 (1-800-264-7661),
    BoironUSA.com Info@boiron.com
    Distributed by Boiron, Inc. Newtown Square, PA 19073

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    SANGUINARIA CANADENSIS 
    sanguinaria canadensis root pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0220-4486
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508) (SANGUINARIA CANADENSIS ROOT - UNII:N9288CD508) SANGUINARIA CANADENSIS ROOT200 [kp_C]  in 200 [kp_C]
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    Product Characteristics
    ColorwhiteScore    
    ShapeROUNDSize4mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0220-4486-41200 [kp_C] in 1 TUBE; Type 0: Not a Combination Product03/03/1983
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/03/1983
    Labeler - Boiron (282560473)
    Registrant - Boiron, Inc. (014892269)
    Establishment
    NameAddressID/FEIBusiness Operations
    Boiron282560473manufacture(0220-4486)
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