NICOTINE - nicotine lozenge 
Kroger Company

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Kroger Co. Nicotine Polacrilex Lozenge 4 mg (Nicotine) Drug Facts

Active ingredient (in each lozenge)

Nicotine polacrilex, 4 mg (nicotine)

Purpose

Stop smoking aid

Uses

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.

Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

Stop use and ask a doctor if

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.

Directions

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, flavor, magnesium stearate, mannitol, potassium bicarbonate, sodium alginate, sodium carbonate, xanthan gum

Questions or comments?

call toll-free 1-866-751-9303

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New Package! {VIAL PACKAGING CONFIGURATION ONLY}

Nicotine Polacrilex Lozenge 4 mg (nicotine)

Stop Smoking Aid

For those who smoke their first cigarette within 30 minutes of waking up.

If you smoke your first cigarette more than 30 minutes after waking up, use Nicotine Polacrilex Lozenge, 2 mg

Includes User’s Guide

Mint Flavor

4 mg

QuitTube {VIAL PACKAGING CONFIGURATION ONLY}

4 mg each

(# QuitTube™ containers of #) {VIAL PACKAGING CONFIGURATION ONLY}

Nicotine Polacrilex Lozenge 4 mg (Nicotine) Carton

Nicotine Polacrilex Lozenge 4 mg (Nicotine) Carton


NICOTINE 
nicotine polacrilex   lozenge
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 30142-873
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NICOTINE (NICOTINE) NICOTINE 4 mg
Inactive Ingredients
Ingredient Name Strength
No Inactive Ingredients Found
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 16mm
Flavor MINT Imprint Code L873
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 30142-873-05 3 VIAL In 1 CARTON contains a VIAL
1 24 LOZENGE In 1 VIAL This package is contained within the CARTON (30142-873-05)
2 30142-873-06 4 VIAL In 1 CARTON contains a VIAL
2 24 LOZENGE In 1 VIAL This package is contained within the CARTON (30142-873-06)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077007 04/27/2007

Labeler - Kroger Company (006999528)
Revised: 06/2009 Kroger Company