Label: THEA SINENSIS pellet

  • NDC Code(s): 37662-1606-1, 37662-1606-2, 37662-1606-3, 37662-1607-1, view more
    37662-1607-2, 37662-1607-3, 37662-1608-1, 37662-1608-2, 37662-1608-3, 37662-1608-4, 37662-1609-1, 37662-1609-2, 37662-1609-3, 37662-1609-4, 37662-1610-1, 37662-1610-2, 37662-1610-3, 37662-1610-4, 37662-1611-1, 37662-1611-2, 37662-1611-3, 37662-1611-4, 37662-1612-1, 37662-1612-2, 37662-1612-3, 37662-1612-4, 37662-1613-1
  • 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 September 25, 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

    Thea Sinensis 6C 5gThea Sinensis 6C 30gThea Sinensis 6C 100gThea Sinensis 12C 5gThea Sinensis 12C 30gThea Sinensis 12C 100gThea Sinensis 30C 1gThea Sinensis 30C 5gThea Sinensis 30C 30gThea Sinensis 30C 100gThea Sinensis 100C 1gThea Sinensis 100C 5gThea Sinensis 100C 30gThea Sinensis 100C 100gThea Sinensis 200C 1gThea Sinensis 200C 5gThea Sinensis 200C 30gThea Sinensis 200C 100gThea Sinensis 500C 1gThea Sinensis 500C 5gThea Sinensis 500C 30gThea Sinensis 500C 100gThea Sinensis 1M 1gThea Sinensis 1M 5gThea Sinensis 1M 30gThea Sinensis 1M 100gThea Sinensis LM1 30g

  • INGREDIENTS AND APPEARANCE
    THEA SINENSIS 
    thea sinensis pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-1607
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GREEN TEA LEAF (UNII: W2ZU1RY8B0) (GREEN TEA LEAF - UNII:W2ZU1RY8B0) GREEN TEA LEAF12 [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:37662-1607-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product09/25/2022
    2NDC:37662-1607-21200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product09/25/2022
    3NDC:37662-1607-34000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product09/25/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic09/25/2022
    THEA SINENSIS 
    thea sinensis pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-1608
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GREEN TEA LEAF (UNII: W2ZU1RY8B0) (GREEN TEA LEAF - UNII:W2ZU1RY8B0) GREEN TEA LEAF30 [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:37662-1608-180 in 1 VIAL, GLASS; Type 0: Not a Combination Product09/25/2022
    2NDC:37662-1608-2200 in 1 VIAL, GLASS; Type 0: Not a Combination Product09/25/2022
    3NDC:37662-1608-31200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product09/25/2022
    4NDC:37662-1608-44000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product09/25/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic09/25/2022
    THEA SINENSIS 
    thea sinensis pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-1606
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GREEN TEA LEAF (UNII: W2ZU1RY8B0) (GREEN TEA LEAF - UNII:W2ZU1RY8B0) GREEN TEA LEAF6 [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:37662-1606-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product09/25/2022
    2NDC:37662-1606-21200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product09/25/2022
    3NDC:37662-1606-34000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product09/25/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic09/25/2022
    THEA SINENSIS 
    thea sinensis pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-1609
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GREEN TEA LEAF (UNII: W2ZU1RY8B0) (GREEN TEA LEAF - UNII:W2ZU1RY8B0) GREEN TEA LEAF100 [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:37662-1609-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product09/25/2022
    2NDC:37662-1609-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product09/25/2022
    3NDC:37662-1609-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product09/25/2022
    4NDC:37662-1609-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product09/25/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic09/25/2022
    THEA SINENSIS 
    thea sinensis pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-1610
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GREEN TEA LEAF (UNII: W2ZU1RY8B0) (GREEN TEA LEAF - UNII:W2ZU1RY8B0) GREEN TEA LEAF200 [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:37662-1610-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product09/25/2022
    2NDC:37662-1610-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product09/25/2022
    3NDC:37662-1610-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product09/25/2022
    4NDC:37662-1610-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product09/25/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic09/25/2022
    THEA SINENSIS 
    thea sinensis pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-1613
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GREEN TEA LEAF (UNII: W2ZU1RY8B0) (GREEN TEA LEAF - UNII:W2ZU1RY8B0) GREEN TEA LEAF1 [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:37662-1613-110000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product09/25/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic09/25/2022
    THEA SINENSIS 
    thea sinensis pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-1612
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GREEN TEA LEAF (UNII: W2ZU1RY8B0) (GREEN TEA LEAF - UNII:W2ZU1RY8B0) GREEN TEA LEAF1 [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:37662-1612-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product09/25/2022
    2NDC:37662-1612-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product09/25/2022
    3NDC:37662-1612-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product09/25/2022
    4NDC:37662-1612-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product09/25/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic09/25/2022
    THEA SINENSIS 
    thea sinensis pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-1611
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GREEN TEA LEAF (UNII: W2ZU1RY8B0) (GREEN TEA LEAF - UNII:W2ZU1RY8B0) GREEN TEA LEAF500 [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:37662-1611-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product09/25/2022
    2NDC:37662-1611-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product09/25/2022
    3NDC:37662-1611-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product09/25/2022
    4NDC:37662-1611-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product09/25/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic09/25/2022
    Labeler - Hahnemann Laboratories, INC. (147098081)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hahnemann Laboratories, INC.147098081manufacture(37662-1606, 37662-1607, 37662-1608, 37662-1609, 37662-1610, 37662-1611, 37662-1612, 37662-1613)