NICOTINE POLACRILEX- nicotine polacrilex lozenge 
Dr. Reddy's Laboratories Inc.

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Nicotine Polacrilex Lozenges Original

PACKAGE LABEL PRINCIPAL DISPLAY PANEL SECTION

Nicotine Polacrilex Lozenges 2 mg Original - Foil Pouch Label

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PACKAGE LABEL PRINCIPAL DISPLAY PANEL SECTION

Nicotine Polacrilex Lozenges 4 mg Original - Foil Pouch Label

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NICOTINE POLACRILEX 
nicotine polacrilex lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43598-484
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Nicotine (UNII: 6M3C89ZY6R) (Nicotine - UNII:6M3C89ZY6R) Nicotine2 mg
Inactive Ingredients
Ingredient NameStrength
Polacrilin (UNII: RCZ785HI7S)  
Acacia (UNII: 5C5403N26O)  
Glycerin (UNII: PDC6A3C0OX)  
Mentha Arvensis Leaf Oil (UNII: 1AEY1M553N)  
Magnesium Stearate (UNII: 70097M6I30)  
Mannitol (UNII: 3OWL53L36A)  
Menthol (UNII: L7T10EIP3A)  
Peppermint Oil (UNII: AV092KU4JH)  
Potassium Bicarbonate (UNII: HM5Z15LEBN)  
Sodium Alginate (UNII: C269C4G2ZQ)  
Sodium Carbonate (UNII: 45P3261C7T)  
Sucralose (UNII: 96K6UQ3ZD4)  
Triacetin (UNII: XHX3C3X673)  
Xanthan Gum (UNII: TTV12P4NEE)  
Product Characteristics
ColorWHITE (White to off white) Scoreno score
ShapeROUNDSize16mm
FlavorImprint Code N484
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43598-484-998333 in 1 POUCH; Type 0: Not a Combination Product02/21/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Export only02/21/2020
NICOTINE POLACRILEX 
nicotine polacrilex lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43598-485
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Nicotine (UNII: 6M3C89ZY6R) (Nicotine - UNII:6M3C89ZY6R) Nicotine4 mg
Inactive Ingredients
Ingredient NameStrength
Polacrilin (UNII: RCZ785HI7S)  
Acacia (UNII: 5C5403N26O)  
Glycerin (UNII: PDC6A3C0OX)  
Mentha Arvensis Leaf Oil (UNII: 1AEY1M553N)  
Magnesium Stearate (UNII: 70097M6I30)  
Mannitol (UNII: 3OWL53L36A)  
Menthol (UNII: L7T10EIP3A)  
Peppermint Oil (UNII: AV092KU4JH)  
Potassium Bicarbonate (UNII: HM5Z15LEBN)  
Sodium Alginate (UNII: C269C4G2ZQ)  
Sodium Carbonate (UNII: 45P3261C7T)  
Sucralose (UNII: 96K6UQ3ZD4)  
Triacetin (UNII: XHX3C3X673)  
Xanthan Gum (UNII: TTV12P4NEE)  
Product Characteristics
ColorWHITE (White to off white) Scoreno score
ShapeROUNDSize16mm
FlavorImprint Code N485
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43598-485-998333 in 1 POUCH; Type 0: Not a Combination Product02/21/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Export only02/21/2020
Labeler - Dr. Reddy's Laboratories Inc. (802315887)

Revised: 4/2020
Document Id: 062145ed-4b88-2c80-624a-9f90a2cf67e8
Set id: 5cab76ed-d0bf-0dce-d4d2-5603b7efb400
Version: 2
Effective Time: 20200424
 
Dr. Reddy's Laboratories Inc.