Label: BISMUTHUM OXYDATUM pellet

  • NDC Code(s): 63545-483-01, 63545-483-02, 63545-483-03, 63545-484-01, view more
    63545-484-02, 63545-484-03, 63545-485-01, 63545-485-02, 63545-485-03, 63545-485-04, 63545-486-01, 63545-486-02, 63545-486-03, 63545-486-04, 63545-487-01, 63545-487-02, 63545-487-03, 63545-487-04, 63545-488-01, 63545-488-02, 63545-488-03, 63545-488-04, 63545-489-01, 63545-489-02, 63545-489-03, 63545-489-04, 63545-490-01
  • Packager: Hahnemann Laboratories, INC.
  • 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 May 2, 2022

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

  • ACTIVE INGREDIENT

  • DOSAGE FORMS & STRENGTHS

  • ACTIVE INGREDIENT

  • PURPOSE

  • INDICATIONS & USAGE

  • WARNINGS

  • PREGNANCY OR BREAST FEEDING

  • ASK DOCTOR

  • KEEP OUT OF REACH OF CHILDREN

  • INSTRUCTIONS FOR USE

  • DOSAGE & ADMINISTRATION

  • ROUTE, METHOD AND FREQUENCY OF ADMINISTRATION

  • INACTIVE INGREDIENT

  • QUESTIONS

  • PRINCIPAL DISPLAY PANEL

    Bismuthum Oxydatum 6C 5gBismuthum Oxydatum 6C 30gBismuthum Oxydatum 6C 100gBismuthum Oxydatum 12C 5gBismuthum Oxydatum 12C 30gBismuthum Oxydatum 12C 100gBismuthum Oxydatum 30C 1gBismuthum Oxydatum 30C 5gBismuthum Oxydatum 30C 30gBismuthum Oxydatum 30C 100gBismuthum Oxydatum 100C 1gBismuthum Oxydatum 100C 5gBismuthum Oxydatum 100C 30gBismuthum Oxydatum 100C 100gBismuthum Oxydatum 200C 1gBismuthum Oxydatum 200C 5gBismuthum Oxydatum 200C 30gBismuthum Oxydatum 200C 100gBismuthum Oxydatum 500C 1gBismuthum Oxydatum 500C 5gBismuthum Oxydatum 500C 30gBismuthum Oxydatum 500C 100gBismuthum Oxydatum 1M 1gBismuthum Oxydatum 1M 5gBismuthum Oxydatum 1M 30gBismuthum Oxydatum 1M 100gBismuthum Oxydatum LM1 30g

  • INGREDIENTS AND APPEARANCE
    BISMUTHUM OXYDATUM 
    bismuthum oxydatum pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-483
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BISMUTH OXIDE (UNII: A6I4E79QF1) (BISMUTH CATION - UNII:ZS9CD1I8YE) BISMUTH OXIDE6 [hp_C]
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize3mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63545-483-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/02/2022
    2NDC:63545-483-021200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/02/2022
    3NDC:63545-483-034000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/02/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic05/02/2022
    BISMUTHUM OXYDATUM 
    bismuthum oxydatum pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-484
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BISMUTH OXIDE (UNII: A6I4E79QF1) (BISMUTH CATION - UNII:ZS9CD1I8YE) BISMUTH OXIDE12 [hp_C]
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize3mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63545-484-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/02/2022
    2NDC:63545-484-021200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/02/2022
    3NDC:63545-484-034000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/02/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic05/02/2022
    BISMUTHUM OXYDATUM 
    bismuthum oxydatum pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-485
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BISMUTH OXIDE (UNII: A6I4E79QF1) (BISMUTH CATION - UNII:ZS9CD1I8YE) BISMUTH OXIDE30 [hp_C]
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize3mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63545-485-0180 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/02/2022
    2NDC:63545-485-02200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/02/2022
    3NDC:63545-485-031200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/02/2022
    4NDC:63545-485-044000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/02/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic05/02/2022
    BISMUTHUM OXYDATUM 
    bismuthum oxydatum pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-486
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BISMUTH OXIDE (UNII: A6I4E79QF1) (BISMUTH CATION - UNII:ZS9CD1I8YE) BISMUTH OXIDE100 [hp_C]
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize2mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63545-486-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/02/2022
    2NDC:63545-486-02500 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/02/2022
    3NDC:63545-486-033000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/02/2022
    4NDC:63545-486-0410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/02/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic05/02/2022
    BISMUTHUM OXYDATUM 
    bismuthum oxydatum pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-487
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BISMUTH OXIDE (UNII: A6I4E79QF1) (BISMUTH CATION - UNII:ZS9CD1I8YE) BISMUTH OXIDE200 [hp_C]
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize2mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63545-487-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/02/2022
    2NDC:63545-487-02500 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/02/2022
    3NDC:63545-487-033000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/02/2022
    4NDC:63545-487-0410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/02/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic05/02/2022
    BISMUTHUM OXYDATUM 
    bismuthum oxydatum pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-488
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BISMUTH OXIDE (UNII: A6I4E79QF1) (BISMUTH CATION - UNII:ZS9CD1I8YE) BISMUTH OXIDE500 [hp_C]
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize2mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63545-488-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/02/2022
    2NDC:63545-488-02500 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/02/2022
    3NDC:63545-488-033000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/02/2022
    4NDC:63545-488-0410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/02/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic05/02/2022
    BISMUTHUM OXYDATUM 
    bismuthum oxydatum pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-489
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BISMUTH OXIDE (UNII: A6I4E79QF1) (BISMUTH CATION - UNII:ZS9CD1I8YE) BISMUTH OXIDE1 [hp_M]
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize2mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63545-489-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/02/2022
    2NDC:63545-489-02500 in 1 VIAL, GLASS; Type 0: Not a Combination Product05/02/2022
    3NDC:63545-489-033000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/02/2022
    4NDC:63545-489-0410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/02/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic05/02/2022
    BISMUTHUM OXYDATUM 
    bismuthum oxydatum pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-490
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BISMUTH OXIDE (UNII: A6I4E79QF1) (BISMUTH CATION - UNII:ZS9CD1I8YE) BISMUTH OXIDE1 [hp_Q]
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize1mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63545-490-0110000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/02/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic05/02/2022
    Labeler - Hahnemann Laboratories, INC. (147098081)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hahnemann Laboratories, INC.147098081manufacture(63545-483, 63545-484, 63545-485, 63545-486, 63545-487, 63545-488, 63545-489, 63545-490)