NICORETTE 4MG CINNAMON SURGE- nicotine polacrilex gum, chewing

Nicorette 4mg Cinnamon Surge by

Drug Labeling and Warnings

Nicorette 4mg Cinnamon Surge by is a Otc medication manufactured, distributed, or labeled by Lil' Drug Store products, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

​Drug Facts

Active ingredient

Active ingredient (in each chewing piece)

Nicotine polacrilex (equal to 4 mg nicotine)

Purpose

​Purpose

Stop smoking aid

Use

Use

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

Warnings

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

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 blood pressure.
• stomach ulcer or diabetes
• history of seizures

Ask a doctor or pharmacist before use

Ask a doctor or pharmacist before use if you are

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

Stop use and ask a doctor

Stop use and ask a doctor if

• mouth, teeth or jaw problems occur
• irregular heartbeat or palpitations occur
• you get symptoms of nicotine overdose such as nausea, vomiting, dizziness, diarrhea, weakness and rapid heartbeat
• oral blistering occurs
• you have symptoms of an allergic reaction (such as difficulty breathing or rash)

Keep out of reach of children and pets

Keep out of reach of children and pets. Pieces of nicotine gum may have enough nicotine to make children and pets sick. Wrap used pieces of gum in paper and throw away in the trash. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

Directions

• if you are under 18 years of age, ask a doctor before use
• before using this product, read the enclosed User’s Guide for complete directions and other important information
• begin using the gum on your quit day
• if you smoke your first cigarette more than 30 minutes after waking up, use 2 mg nicotine gum
• if you smoke your first cigarette within 30 minutes of waking up, use 4 mg nicotine gum according to the following 12 week schedule:

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

• nicotine gum is a medicine and must be used a certain way to get the best results
• chew the gum slowly until it tingles. Then park it between your cheek and gum. When the tingle is gone, begin chewing again, until the tingle returns.
• repeat this process until most of the tingle is gone (about 30 minutes)
• do not eat or drink for 15 minutes before chewing the nicotine gum, or while chewing a piece
• to improve your chances of quitting, use at least 9 pieces per day for the first 6 weeks
• if you experience strong or frequent cravings, you may use a second piece within the hour. However, do not continuously use one piece after another since this may cause you hiccups, heartburn, nausea or other side effects.
• do not use more than 24 pieces a day
• it is important to complete treatment. If you feel you need to use the gum for a longer period to keep from smoking, talk to your health care provider.

Other information

Other information

• each piece contains: calcium 94 mg, sodium 13 mg
• store at 20 - 25°C (68 - 77°F)
• protect from light

Inactive ingredients

Inactive ingredients

acacia, acesulfame potassium, carnauba wax, D&C yellow #10 Al. lake, edible ink, gum base, hypromellose, magnesium oxide, menthol, natural and artificial cinnamon flavors, peppermint oil, polysorbate 80, sodium carbonate, sucralose, titanium dioxide, xylitol

Questions or comments?

Questions or comments? call toll-free 1-800-419-4766

SPL UNCLASSIFIED SECTION

Manufactured for: Haleon, Warren, NJ 07059
Made in Sweden ©2023 Haleon group of companies or its licensor.
Trademarks are owned by or licensed to the Haleon group of companies.

Packaged and distributed with permission of Haleon by:
Lil’ Drug Store Products, Inc., 9300 Earhart Lane SW, Cedar Rapids, IA 52404
1-877-507-6516 (8AM - 4:30 PM CST)

Nicorette 4mg Cinnamon Surge, Lil' Drug Store ® - PDP/Package

This package size may not be
a full day’s supply; it is intended
to start or continue a quit attempt.

Nicorette

nicotine polacrilex gum, 4 mg stop smoking aid

Gum

[product image]

Coated

FOR BOLD FLAVOR

Cinnamon Surge

4 mg

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 Nicorette 2 mg Gum.

10 PIECES, 4 mg EACH

[Lil' Drug Store ® logo]

INGREDIENTS AND APPEARANCE

NICORETTE 4MG CINNAMON SURGE 
nicotine polacrilex gum, chewing

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66715-8123
Route of Administration	BUCCAL

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

Inactive Ingredients
Ingredient Name	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
ACACIA (UNII: 5C5403N26O)
ALUMINUM OXIDE (UNII: LMI26O6933)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SODIUM CARBONATE (UNII: 45P3261C7T)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)
PEPPERMINT OIL (UNII: AV092KU4JH)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XYLITOL (UNII: VCQ006KQ1E)
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
CARNAUBA WAX (UNII: R12CBM0EIZ)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)

Product Characteristics
Color	white ((cream))	Score	no score
Shape	SQUARE	Size	15mm
Flavor	CINNAMON	Imprint Code	N4
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66715-8123-0	1 in 1 CARTON	05/06/2022
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA020066	05/06/2022

Labeler - Lil' Drug Store products, Inc. (093103646)