Label: BROMIUM- bromine 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 November 9, 2023

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  • ACTIVE INGREDIENT

    BROMIUM HPUS

    6X 6C 30C

  • PURPOSE

  • INDICATIONS & USAGE

    Sore throat pain worsened by heat*

  • WARNINGS

  • STOP USE

    STOP USE AND SEE 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

  • DOSAGE & ADMINISTRATION

    5 PELLETS 3 TIMES A DAY UNTIL SYMPTOMS ARE RELIEVED

  • SPL UNCLASSIFIED SECTION

    DO NOT USE IF PELLET DISPENSER SEAL IS BROKEN

    CONTAINS APPROX 80 PELLETS

  • INACTIVE INGREDIENT

    LACTOSE, SUCROSE

  • QUESTIONS

    1-800-BOIRON-1

    Newtown Square, PA 19073-3267

    info@boironusa.com

  • SPL UNCLASSIFIED SECTION

    These "uses" have not been evaluated by the FDA

  • PRINCIPAL DISPLAY PANEL

    labellabel

  • INGREDIENTS AND APPEARANCE
    BROMIUM 
    bromine pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0220-0907
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BROMINE (UNII: SBV4XY874G) (BROMINE - UNII:SBV4XY874G) BROMINE6 [hp_X]  in 6 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorwhiteScore    
    ShapeROUNDSize4mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0220-0907-416 [hp_X] 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(0220-0907)
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