GOOD SENSE NICOTINE - nicotine polacrilex lozenge 
Dispensing Solutions, Inc.

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Perrigo Nicotine Lozenge Drug Facts

Active ingredient (in each lozenge)

Nicotine polacrilex, 2 mg (nicotine)

Purpose

Stop smoking aid

Uses

Warnings

Enter section text here

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.

Do not use

  • if you continue to smoke, chew tobacco, use snuff, or use a nicotine patch or other nicotine containing products

Ask a doctor before use if you have

  • a sodium-restricted diet
  • 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

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 or rapid heartbeat

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 overdoe, get medical help or contact a Poison Control Center right away.

Directions

Weeks 1 to 6Weeks 7 to 9Weeks 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, flavor, magnesium stearate, mannitol, potassium bicarbonate, sodium alginate, sodium carbonate, xanthan gum

Questions or comments?

call toll-free 1-866-751-9303

Principal Display Panel


NDC 68258-7991-07

NDC 68258-7991-07

GOOD SENSE NICOTINE 
nicotine polacrilex lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68258-7991(NDC:0113-0344)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE2 mg
Inactive Ingredients
Ingredient NameStrength
ASPARTAME (UNII: Z0H242BBR1)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MANNITOL (UNII: 3OWL53L36A)  
POTASSIUM BICARBONATE (UNII: HM5Z15LEBN)  
SODIUM ALGINATE (UNII: C269C4G2ZQ)  
SODIUM CARBONATE (UNII: 45P3261C7T)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize16mm
FlavorMINTImprint Code L344
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68258-7991-73 in 1 CARTON
124 in 1 VIAL
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07700711/28/2009
Labeler - Dispensing Solutions, Inc. (066070785)
Registrant - PSS World Medical, Inc. (101822682)
Establishment
NameAddressID/FEIBusiness Operations
Dispensing Solutions, Inc.066070785relabel, repack

Revised: 3/2012
Document Id: 4b7832cb-8420-47b0-b947-363aa54e2ca1
Set id: 4bb7687d-3ee0-47a3-aa43-146dede4cf55
Version: 1
Effective Time: 20120307
 
Dispensing Solutions, Inc.