NICOTINE Oral Pouch - Guangzhou Shuimu Jiahe Trading Co., Ltd.

Manufacturer
Guangzhou Shuimu Jiahe Trading Co., Ltd.
Effective date
2026-04-24
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:54:49

Label at a glance#

ProductNICOTINE Oral Pouch
Active ingredientNICOTINE
Label structure9 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 (8 mg per pouch)

OTC - ASK DOCTOR SECTION

Ask a doctor or pharmacist before use if you are: Using a non-nicotine stopsmokindrug. Taking a prescription medicine for depression or asthma. Yourprescription dose may need to be adiusted.

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 ofyour health care provider. smoking can seriously harm your child. Try to stopsmoking without using any nicotine replacement medicine. This medicine isbelieved to be safer than smoking. However, the risks to your child from thismedicine are not fully known.

INDICATIONS & USAGE SECTION

To use, place one pouch between your gum and lip. Leave it in place. Do not chewor swallow the pouch.
-You may feel a slight tingling sensation.-Do not eat or drink 15 minutes before using or while the pouch is in your mouth,to maximize the experience.
-lf you are using this product to change your habits, using at least a certainnumber of pouches per day initially may help manage urges.-Do not use more than one pouch at a time or continuously use one pouch afteranother, as this may cause hiccups, heartburn, nausea, or other side effects.-Do not exceed your personal tolerance. lt is recommended to start slowly andassess your response.
-Do not use more than 6 pouches in 5 hours. Do not use more than 20 pouches perday.
-lt is important to be mindful of your usage. lf you feel you need to use the pouchfor a longer period to manage your habits, consider consulting your health careprovider for a plan.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
NICOTINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
87494-001-01NICOTINE Oral Pouch45 mg in 1 BOX, UNIT-DOSELOZENGE452
87494-001-02NICOTINE Oral Pouch3 in 1 BOXLOZENGE32

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
87494-00187494-001-01, 87494-001-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12026-03-08monthly-update2026-06-03 17:58:34

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
58618c2b-b944-b310-e063-6394a90a38a44c853456-51ef-abf3-e063-6394a90aa4ce2026-08-06WarningsExact identifier
spl set id: 4c853456-51ef-abf3-e063-6394a90aa4ce

Reported adverse events (FAERS/openFDA)#

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