MINI NICOTINE- nicotine polacrilex lozenge 
ATLANTIC BIOLOGICALS CORP.

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Drug Facts

Active ingredient (in each lozenge)

Nicotine polacrilex 4 mg


Purpose

Stop smoking aid

Use

Warnings

If you are pregnant or breast-feeding,

only use this medicine on the advice of your health care provider. Smoking can seriously harm your child. Try to stop smoking without using any nicotine replacement medicine. This medicine is believed to be safer than smoking. However, the risks to your child from this medicine are not fully known.

Ask a doctor before use if you have

  • heart disease, recent heart attack, or irregular heartbeat. Nicotine can increase your heart rate.
  • high blood pressure not controlled with medication. Nicotine can increase your blood pressure.
  • stomach ulcer or diabetes
  • history of seizures

Ask a doctor or pharmacist before use if you are

  • using a non-nicotine stop smoking drug
  • taking prescription medicine for depression or asthma. Your prescription dose may need to be adjusted.

Stop use and ask a doctor if

  • mouth problems occur
  • persistent indigestion or severe sore throat occurs
  • irregular heartbeat or palpitations occur
  • you get symptoms of nicotine overdose such as nausea, vomiting, dizziness, diarrhea, weakness and rapid heartbeat
  • you have symptoms of an allergic reaction (such as difficulty breathing or rash)

Keep out of reach of children and pets.

Nicotine lozenges may have enough nicotine to make children and pets sick. If you need to remove the lozenge, wrap it in paper and throw away in the trash. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)

Directions (4 mg lozenge)

 Weeks 1 to 6 Weeks 7 to 9 Weeks 10 to 12
 1 lozenge every 1 to 2 hours 1 lozenge every 2 to 4 hours 1 lozenge every 4 to 8 hours

Other information

Inactive ingredients

aspartame, calcium polycarbophil, flavor, maltodextrin, mannitol, sodium alginate, sodium bicarbonate, sodium stearyl fumarate, talc, xanthan gum

Questions or comments?

Call 1-800-645-2158

DISTRIBUTED BY:

ATLANTIC BIOLOGICALS CORP.

MIAMI, FL 33179

Package Label (4 mg lozenge)

Nicotine Polacrilex 4 mg

MINI NICOTINE 
nicotine polacrilex lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17856-1241(NDC:0536-1241)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE4 mg
Inactive Ingredients
Ingredient NameStrength
ASPARTAME (UNII: Z0H242BBR1)  
CALCIUM POLYCARBOPHIL (UNII: 8F049NKY49)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
MANNITOL (UNII: 3OWL53L36A)  
SODIUM ALGINATE (UNII: C269C4G2ZQ)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
TALC (UNII: 7SEV7J4R1U)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize10mm
FlavorMINTImprint Code 131
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:17856-1241-150 in 1 BOX05/08/2024
1NDC:17856-1241-21 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20786807/31/2019
Labeler - ATLANTIC BIOLOGICALS CORP. (047437707)
Registrant - ATLANTIC BIOLOGICALS CORP. (047437707)
Establishment
NameAddressID/FEIBusiness Operations
UNIT DOSE SOLUTIONS360804194repack(17856-1241)

Revised: 5/2024
Document Id: 8bb56c40-d671-4be2-8956-54693470c4c1
Set id: a0fc3eae-9c34-48af-bdd2-d95e91b68a9c
Version: 2
Effective Time: 20240508
 
ATLANTIC BIOLOGICALS CORP.