NICOTINE GUM - Guangzhou Shuimu Jiahe Trading Co., Ltd.

Manufacturer
Guangzhou Shuimu Jiahe Trading Co., Ltd.
Effective date
2026-08-06
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
daily-update
Hydrated at
2026-08-11 01:01:16

Label at a glance#

ProductNICOTINE GUM
Active ingredientNICOTINE
Label structure10 sections

Label contents#

Full prescribing information#

DOSAGE & ADMINISTRATION SECTION

reduces withdrawal symptoms, including nicotine craving, associated withquitting smoking

INACTIVE INGREDIENT SECTION

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

OTC - ACTIVE INGREDIENT SECTION

Nicotine (equal to 4 mg nicotine)

OTC - ASK DOCTOR SECTION

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).

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

OTC - PURPOSE SECTION

Stop smoking aid

WARNINGS SECTION

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 SECTION

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

RECENT MAJOR CHANGES SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

gumgum

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
87494-00287494-002-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32026-05-26daily-update2026-06-03 18:03:26
22026-04-03full-release2026-06-01 01:52:35

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NICOTINE GUMNICOTINE POLACRILEXGuangzhou Shuimu Jiahe Trading Co., Ltd.4e88dab4-8e13-f074-e063-6394a90a39082026-08-06WarningsExact identifier
ndc (package): 87494-002-01
ndc (product): 87494-002
ndc11 (package): 87494000201
spl id: 586357e4-39b2-b944-e063-6294a90ada3d
spl set id: 4e88dab4-8e13-f074-e063-6394a90a3908

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.