Label: HYDRASTIS CANDADENSIS- goldenseal 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 January 20, 2023

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

  • ACTIVE INGREDIENT

    Active ingredient** (in each pellet)

    Hydrastis candadensis 6C HPUS (0.44 mg)

    (contains less than 10-12 mg hydrastine and berberine alkaloids)

    The letter "HPUS" indicate that the component in this product is officially monographed in the Homeopathic Pharmacopoeia of the United States.

  • PURPOSE

    Purpose*

    Hydrastis candadensis 6C HPUS (0.44 mg) ... Relieves post-nasal drip symptoms

  • INDICATIONS & USAGE

    Uses*

    temporarily relieves occasional symptoms of post-nasal drip such as:

    • nasal congestion
    • excess mucus
    • scratch throat

    Tube - Post-Nasal Drip*

  • WARNINGS

  • DO NOT USE

    Do not use if you have a fever.

  • 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 breastfeeding, ask a health professional before use

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • SPL UNCLASSIFIED SECTION

    do not use if glued carton end flaps are open or if pellet dispenser seal is broken

    contains 0.25 g of sugar per dose

    3 TUBES

    APPROX. 80 PELLETS EACH

    TOTAL 240 PELLETS

    MELTAWAY PELLETS

    No Known Drug Interactions

    Non-Drowsy

    Turn tube upside down

    Twist until 5 pellets are dispensed

    Remove cap and pour pellets under the tongue

    Post-Nasal Drip Relief*

    Excess Mucus Scratchy Throat*

    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

    labellabellabel

  • INGREDIENTS AND APPEARANCE
    HYDRASTIS CANDADENSIS 
    goldenseal pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0220-2551
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL6 [hp_C]  in 6 [hp_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:0220-2551-433 in 1 BOX05/03/2022
    1NDC:0220-2551-416 [hp_C] in 1 TUBE; Type 0: Not a Combination Product
    2NDC:0220-2551-416 [hp_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
    Reed Lane, Inc.001819879pack(0220-2551)
    Establishment
    NameAddressID/FEIBusiness Operations
    Boiron282560473manufacture(0220-2551)