NICOTINE POLACRILEX lozenge

Nicotine Polacrilex by

Drug Labeling and Warnings

Nicotine Polacrilex by is a Otc medication manufactured, distributed, or labeled by Dr. Reddy's Laboratories Inc., Fertin Pharma A/S, Legacy Pharmaceutical Packaging, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PACKAGE LABEL PRINCIPAL DISPLAY PANEL SECTION

Fertin Pharma A/S

Nicotine Polacrilex Lozenges 2 mg Original

Ingredients: Mannitol, Xanthan Gum, Sodium alginate, Potassium bicarbonate, Sodium carbonate, flavors, sucralose, NPR, magnesium stearate.

Caution: For manufacturing, processing, or repacking.

Storage condition: 15 - 25 °c

SAP Part No.: 200024921

NDC Code 43598-484-99

Fertin Part No: 1003678

Batch No.: B123456789

RE-PACK THE DRUG PRODUCT WITHIN 12 MONTHS FROM THE DATE OF MANUFACTURE

MFG. Date: 01/2020

Po No.: 1111111111

Nicotine Polacrilex Lozenges 2 mg Original - Foil Pouch Label

PACKAGE LABEL PRINCIPAL DISPLAY PANEL SECTION

Fertin Pharma A/S

Nicotine Polacrilex Lozenges 4 mg Original

Ingredients: Mannitol, Xanthan Gum, Sodium alginate, Potassium bicarbonate, Sodium carbonate, flavors, sucralose, NPR, magnesium stearate.

Caution: For manufacturing, processing, or repacking.

Storage condition: 15 - 25 °c

SAP Part No.: 200024922

NDC Code 43598-485-99

Fertin Part No: 1003679

Batch No.: B123456789

RE-PACK THE DRUG PRODUCT WITHIN 12 MONTHS FROM THE DATE OF MANUFACTURE

MFG. Date: 01/2020

Po No.: 1111111111

Nicotine Polacrilex Lozenges 4 mg Original - Foil Pouch Label

INGREDIENTS AND APPEARANCE

NICOTINE POLACRILEX 
nicotine polacrilex lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43598-484
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Nicotine (UNII: 6M3C89ZY6R) (Nicotine - UNII:6M3C89ZY6R)	Nicotine	2 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	WHITE (White to off white)	Score	no score
Shape	ROUND	Size	16mm
Flavor		Imprint Code	N484
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43598-484-99	8333 in 1 POUCH; Type 0: Not a Combination Product	02/21/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Export only		02/21/2020

NICOTINE POLACRILEX 
nicotine polacrilex lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43598-485
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Nicotine (UNII: 6M3C89ZY6R) (Nicotine - UNII:6M3C89ZY6R)	Nicotine	4 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	WHITE (White to off white)	Score	no score
Shape	ROUND	Size	16mm
Flavor		Imprint Code	N485
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43598-485-99	8333 in 1 POUCH; Type 0: Not a Combination Product	02/21/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Export only		02/21/2020

Labeler - Dr. Reddy's Laboratories Inc. (802315887)

Establishment
Name	Address	ID/FEI	Business Operations
Fertin Pharma A/S		307973565	analysis(43598-484, 43598-485) , manufacture(43598-484, 43598-485)

Establishment
Name	Address	ID/FEI	Business Operations
Legacy Pharmaceutical Packaging, LLC		143213275	repack(43598-484, 43598-485)