PLANTAGO MAJOR- plantago major pellet 
Hahnemann Laboratories, INC.

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.

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PLANTAGO MAJOR 
plantago major pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-1361
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PLANTAGO MAJOR (UNII: W2469WNO6U) (PLANTAGO MAJOR - UNII:W2469WNO6U) PLANTAGO MAJOR200 [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:37662-1361-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product08/12/2022
2NDC:37662-1361-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product08/12/2022
3NDC:37662-1361-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product08/12/2022
4NDC:37662-1361-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product08/12/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic08/12/2022
PLANTAGO MAJOR 
plantago major pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-1362
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PLANTAGO MAJOR (UNII: W2469WNO6U) (PLANTAGO MAJOR - UNII:W2469WNO6U) PLANTAGO MAJOR500 [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:37662-1362-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product08/12/2022
2NDC:37662-1362-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product08/12/2022
3NDC:37662-1362-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product08/12/2022
4NDC:37662-1362-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product08/12/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic08/12/2022
PLANTAGO MAJOR 
plantago major pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-1358
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PLANTAGO MAJOR (UNII: W2469WNO6U) (PLANTAGO MAJOR - UNII:W2469WNO6U) PLANTAGO MAJOR12 [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:37662-1358-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product08/12/2022
2NDC:37662-1358-21200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product08/12/2022
3NDC:37662-1358-34000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product08/12/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic08/12/2022
PLANTAGO MAJOR 
plantago major pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-1359
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PLANTAGO MAJOR (UNII: W2469WNO6U) (PLANTAGO MAJOR - UNII:W2469WNO6U) PLANTAGO MAJOR30 [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:37662-1359-180 in 1 VIAL, GLASS; Type 0: Not a Combination Product08/12/2022
2NDC:37662-1359-2200 in 1 VIAL, GLASS; Type 0: Not a Combination Product08/12/2022
3NDC:37662-1359-31200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product08/12/2022
4NDC:37662-1359-44000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product08/12/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic08/12/2022
PLANTAGO MAJOR 
plantago major pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-1360
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PLANTAGO MAJOR (UNII: W2469WNO6U) (PLANTAGO MAJOR - UNII:W2469WNO6U) PLANTAGO MAJOR100 [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:37662-1360-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product08/12/2022
2NDC:37662-1360-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product08/12/2022
3NDC:37662-1360-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product08/12/2022
4NDC:37662-1360-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product08/12/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic08/12/2022
PLANTAGO MAJOR 
plantago major pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-1357
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PLANTAGO MAJOR (UNII: W2469WNO6U) (PLANTAGO MAJOR - UNII:W2469WNO6U) PLANTAGO MAJOR6 [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:37662-1357-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product08/12/2022
2NDC:37662-1357-21200 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product08/12/2022
3NDC:37662-1357-34000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product08/12/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic08/12/2022
PLANTAGO MAJOR 
plantago major pellet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37662-1363
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PLANTAGO MAJOR (UNII: W2469WNO6U) (PLANTAGO MAJOR - UNII:W2469WNO6U) PLANTAGO MAJOR1 [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:37662-1363-1200 in 1 VIAL, GLASS; Type 0: Not a Combination Product08/12/2022
2NDC:37662-1363-2500 in 1 VIAL, GLASS; Type 0: Not a Combination Product08/12/2022
3NDC:37662-1363-33000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product08/12/2022
4NDC:37662-1363-410000 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product08/12/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic08/12/2022
Labeler - Hahnemann Laboratories, INC. (147098081)
Establishment
NameAddressID/FEIBusiness Operations
Hahnemann Laboratories, INC.147098081manufacture(37662-1357, 37662-1358, 37662-1359, 37662-1360, 37662-1361, 37662-1362, 37662-1363)

Revised: 8/2022
Document Id: e61531a6-8a75-5ec3-e053-2995a90a0a57
Set id: e61531a6-8a74-5ec3-e053-2995a90a0a57
Version: 1
Effective Time: 20220812
 
Hahnemann Laboratories, INC.