Label: ASARUM EUROPAEUM pellet

  • NDC Code(s): 63545-268-01, 63545-268-02, 63545-268-03, 63545-269-01, view more
    63545-269-02, 63545-269-03, 63545-270-01, 63545-270-02, 63545-270-03, 63545-270-04, 63545-271-01, 63545-271-02, 63545-271-03, 63545-271-04, 63545-272-01, 63545-272-02, 63545-272-03, 63545-272-04, 63545-273-01, 63545-273-02, 63545-273-03, 63545-273-04, 63545-274-01, 63545-274-02, 63545-274-03, 63545-274-04
  • 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 April 1, 2021

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

    Asarum Europaeum 6C 5gAsarum Europaeum 6C 30gAsarum Europaeum 6C 100gAsarum Europaeum 12C 5gAsarum Europaeum 12C 30gAsarum Europaeum 12C 100gAsarum Europaeum 30C 1gAsarum Europaeum 30C 5gAsarum Europaeum 30C 30gAsarum Europaeum 30C 100gAsarum Europaeum 100C 1gAsarum Europaeum 100C 5gAsarum Europaeum 100C 30gAsarum Europaeum 100C 100gAsarum Europaeum 200C 1gAsarum Europaeum 200C 5gAsarum Europaeum 200C 30gAsarum Europaeum 200C 100gAsarum Europaeum 500C 1gAsarum Europaeum 500C 5gAsarum Europaeum 500C 30gAsarum Europaeum 500C 100gAsarum Europaeum 1M 1gAsarum Europaeum 1M 5gAsarum Europaeum 1M 30gAsarum Europaeum 1M 100g

  • INGREDIENTS AND APPEARANCE
    ASARUM EUROPAEUM 
    asarum europaeum pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-268
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASARUM EUROPAEUM (UNII: H0876AL67A) (ASARUM EUROPAEUM - UNII:H0876AL67A) ASARUM EUROPAEUM6 [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:63545-268-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product04/02/2021
    2NDC:63545-268-021200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/02/2021
    3NDC:63545-268-034000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/02/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic04/02/2021
    ASARUM EUROPAEUM 
    asarum europaeum pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-269
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASARUM EUROPAEUM (UNII: H0876AL67A) (ASARUM EUROPAEUM - UNII:H0876AL67A) ASARUM EUROPAEUM12 [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:63545-269-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product04/02/2021
    2NDC:63545-269-021200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/02/2021
    3NDC:63545-269-034000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/02/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic04/02/2021
    ASARUM EUROPAEUM 
    asarum europaeum pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-274
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASARUM EUROPAEUM (UNII: H0876AL67A) (ASARUM EUROPAEUM - UNII:H0876AL67A) ASARUM EUROPAEUM1 [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:63545-274-02500 in 1 VIAL, GLASS; Type 0: Not a Combination Product04/02/2021
    2NDC:63545-274-033000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/02/2021
    3NDC:63545-274-0410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/02/2021
    4NDC:63545-274-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product04/02/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic04/02/2021
    ASARUM EUROPAEUM 
    asarum europaeum pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-270
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASARUM EUROPAEUM (UNII: H0876AL67A) (ASARUM EUROPAEUM - UNII:H0876AL67A) ASARUM EUROPAEUM30 [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:63545-270-02200 in 1 VIAL, GLASS; Type 0: Not a Combination Product04/02/2021
    2NDC:63545-270-031200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/02/2021
    3NDC:63545-270-044000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/02/2021
    4NDC:63545-270-0180 in 1 VIAL, GLASS; Type 0: Not a Combination Product04/02/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic04/02/2021
    ASARUM EUROPAEUM 
    asarum europaeum pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-273
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASARUM EUROPAEUM (UNII: H0876AL67A) (ASARUM EUROPAEUM - UNII:H0876AL67A) ASARUM EUROPAEUM500 [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:63545-273-02500 in 1 VIAL, GLASS; Type 0: Not a Combination Product04/02/2021
    2NDC:63545-273-033000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/02/2021
    3NDC:63545-273-0410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/02/2021
    4NDC:63545-273-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product04/02/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic04/02/2021
    ASARUM EUROPAEUM 
    asarum europaeum pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-271
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASARUM EUROPAEUM (UNII: H0876AL67A) (ASARUM EUROPAEUM - UNII:H0876AL67A) ASARUM EUROPAEUM100 [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:63545-271-02500 in 1 VIAL, GLASS; Type 0: Not a Combination Product04/02/2021
    2NDC:63545-271-033000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/02/2021
    3NDC:63545-271-0410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/02/2021
    4NDC:63545-271-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product04/02/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic04/02/2021
    ASARUM EUROPAEUM 
    asarum europaeum pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63545-272
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASARUM EUROPAEUM (UNII: H0876AL67A) (ASARUM EUROPAEUM - UNII:H0876AL67A) ASARUM EUROPAEUM200 [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:63545-272-02500 in 1 VIAL, GLASS; Type 0: Not a Combination Product04/02/2021
    2NDC:63545-272-033000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/02/2021
    3NDC:63545-272-0410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/02/2021
    4NDC:63545-272-01200 in 1 VIAL, GLASS; Type 0: Not a Combination Product04/02/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic04/02/2021
    Labeler - Hahnemann Laboratories, Inc. (147098081)
    Registrant - Hahnemann Laboratories, Inc. (147098081)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hahnemann Laboratories, Inc.147098081manufacture(63545-268, 63545-269, 63545-270, 63545-271, 63545-272, 63545-273, 63545-274)