NICOTINE GUM- nicotine polacrilex gum, chewing

Drug Labeling and Warnings

Drug Details [pdf]

DOSAGE & ADMINISTRATION

reduces withdrawal symptoms, including nicotine craving, associated withquitting smoking

INACTIVE INGREDIENT

Microcrystalline cellulose, mannitol, propylene glycolsodium chloride, sodium bicarbonate, acesulfame, edible essence.

ACTIVE INGREDIENT

Nicotine (8 mg per pouch)

ASK DOCTOR

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.

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, 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

you have symptoms of an allergic reaction (such as difficulty breathing or rash).

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

PURPOSE

Stop smoking aid

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.

INDICATIONS & USAGE

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 Nicotine Polacrilex Gum, 4 mg

your first cigarette within 30 minutes of waking up, use Nicotine Polacrilex Gum, 4 mg according to the following 12 week schedule:

Weeks 1–6 Weeks 7–9 Weeks 10–12
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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

NICOTINE GUM 
nicotine polacrilex gum, chewing

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 87494-002
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R)	NICOTINE	4 mg  in 1000 mg

Inactive Ingredients
Ingredient Name	Strength
TALC (UNII: 7SEV7J4R1U)
SODIUM CARBONATE (UNII: 45P3261C7T)
CARNAUBA WAX (UNII: R12CBM0EIZ)
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
CALCIUM CARBONATE (UNII: H0G9379FGK)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
GELATIN (UNII: 2G86QN327L)
MANNITOL (UNII: 3OWL53L36A)
MENTHOL (UNII: L7T10EIP3A)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
MINT (UNII: FV98Z8GITP)
SUCRALOSE (UNII: 96K6UQ3ZD4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
XYLITOL (UNII: VCQ006KQ1E)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	white	Score	score with uneven pieces
Shape	SQUARE	Size	10mm
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 87494-002-01	48 mg in 1 BOX, UNIT-DOSE; Type 0: Not a Combination Product	04/03/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	04/03/2026

Labeler - Guangzhou Shuimu Jiahe Trading Co., Ltd. (700938261)

Establishment
Name	Address	ID/FEI	Business Operations
Guangzhou Shuimu Jiahe Trading Co., Ltd.		700938261	manufacture(87494-002)