Maxi Nicotine: Package Insert and Label Information

MAXI NICOTINE- nicotine lozenge
Walgreens

Active ingredient (in each lozenge)

Nicotine polacrilex USP, 4 mg

Purpose

Stop smoking aid

Use

  • reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking

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

  • 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
  • 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 (1-800-222-1222) right away

Directions

  • if you are under 18 years of age, ask a doctor before use. No studies have been done to show if this product will work for you.
  • before using this product, read the enclosed User’s Guide for complete directions and other important information
  • begin using the lozenge on your quit day
  • if you smoke your first cigarette more than 30 minutes after waking up, use 2 mg nicotine lozenge
  • if you smoke your first cigarette within 30 minutes of waking up, use 4 mg nicotine lozenge according to the following 12 week schedule:
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
  • nicotine lozenge is a medicine and must be used a certain way to get the best results
  • place the lozenge in your mouth and allow the lozenge to slowly dissolve (about 20 to 30 minutes). Minimize swallowing. Do not chew or swallow lozenge.
  • you may feel a warm or tingling sensation
  • occasionally move the lozenge from one side of your mouth to the other until completely dissolved (about 20 to 30 minutes)
  • do not eat or drink 15 minutes before using or while the lozenge is in your mouth
  • to improve your chances of quitting, use at least 9 lozenges per day for the first 6 weeks
  • do not use more than one lozenge at a time or continuously use one lozenge after another since this may cause you hiccups, heartburn, nausea or other side effects
  • do not use more than 5 lozenges in 6 hours. Do not use more than 20 lozenges per day.
  • It is important to complete treatment. If you feel you need to use the lozenge for a longer period to keep from smoking, talk to your health care provider.

Other information

  • each lozenge contains: sodium 14 mg
  • store at 20º-25ºC (68º-77ºF)
  • keep bottle tightly closed and protect from light

Inactive ingredients

acesulfame potassium, colloidal silicon dioxide, cherry flavor, hydroxypropyl cellulose, magnesium stearate, mannitol, potassium bicarbonate, povidone, sodium alginate, sodium carbonate, sucralose,xanthan gum

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to the active ingredient in Nicorette® Lozenge††

Nicotine Lozenge

NICOTINE POLACRILEX LOZENGE 4 mg (NICOTINE)

STOP SMOKING AID

SUGAR FREE

  • Includes user’s guide

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 2 mg Lozenge.

Cherry flavor

LOZENGES , 4 mg Each

TO INCREASE YOUR SUCCESS IN QUITTING:

1. You must be motivated to quit.

2. Use Enough — Use at least 9 Nicotine Polacrilex lozenges per day during the first six weeks.

3. Use Long Enough — Use Nicotine Polacrilex lozenges for the full 12 weeks.

4. Use With a Support Program as directed in the enclosed User’s Guide.

Retain outer carton for full product uses, directions and warnings.

  • NOT FOR SALE TO THOSE UNDER 18 YEARS OF AGE
  • PROOF OF AGE REQUIRED
  • NOT FOR SALE IN VENDING MACHINE OR FROM ANY SOURCE WHERE PROOF OF AGE CANNOT BE VERIFIED

††This product is not manufactured or distributed by GlaxoSmithKline Consumer Healthcare, L.P., owner of the registered trademark Nicorette®.

TAMPER EVIDENT FEATURE: DO NOT USE IF PRINTED SEAL UNDER CAP IS BROKEN OR MISSING.

OPENING DIRECTIONS: PUSH DOWN ON CAP AND TURN TO OPEN.

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

Package Label

Nicotine Polacrilex USP, 4 mg
(click image for full-size original)

WALGREENS Sugar Free Nicotine Lozenge Cherry Flavor

MAXI NICOTINE
nicotine polacrilex lozenge
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0960
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
ACESULFAME POTASSIUM
SILICON DIOXIDE
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
MAGNESIUM STEARATE
MANNITOL
POTASSIUM BICARBONATE
POVIDONE
SODIUM ALGINATE
SODIUM CARBONATE
SUCRALOSE
XANTHAN GUM
Product Characteristics
Color white (off white) Score no score
Shape ROUND Size 16mm
Flavor CHERRY Imprint Code A710
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0363-0960-08 4 BOTTLE, PLASTIC in 1 BOX contains a BOTTLE, PLASTIC
1 27 LOZENGE in 1 BOTTLE, PLASTIC This package is contained within the BOX (0363-0960-08)
2 NDC:0363-0960-72 3 BOTTLE, PLASTIC in 1 BOX contains a BOTTLE, PLASTIC
2 24 LOZENGE in 1 BOTTLE, PLASTIC This package is contained within the BOX (0363-0960-72)
3 NDC:0363-0960-27 1 BOTTLE, PLASTIC in 1 BOX contains a BOTTLE, PLASTIC
3 27 LOZENGE in 1 BOTTLE, PLASTIC This package is contained within the BOX (0363-0960-27)
4 NDC:0363-0960-24 1 BOTTLE, PLASTIC in 1 BOX contains a BOTTLE, PLASTIC
4 24 LOZENGE in 1 BOTTLE, PLASTIC This package is contained within the BOX (0363-0960-24)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210712 10/30/2020
Labeler — Walgreens (008965063)

Revised: 03/2022 Walgreens

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