NICOTINE ORAL POUCH- nicotine lozenge

NICOTINE Oral Pouch by

Drug Labeling and Warnings

NICOTINE Oral Pouch by is a Otc medication manufactured, distributed, or labeled by Guangzhou Shuimu Jiahe Trading Co., Ltd.. Drug facts, warnings, and ingredients follow.

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 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.

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 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

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

NICOTINE ORAL POUCH 
nicotine lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 87494-001
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R)	NICOTINE	8 mg  in 1000 mg

Inactive Ingredients
Ingredient Name	Strength
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
CEFATRIZINE PROPYLENE GLYCOLATE (UNII: 3731IA5GI9)
ACESULFAME (UNII: MA3UYZ6K1H)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
FLAVOR SPICE MINT N&A110589 (UNII: KG6KU384XW)
MANNITOL (UNII: 3OWL53L36A)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

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: 87494-001-01	45 mg in 1 BOX, UNIT-DOSE; Type 0: Not a Combination Product	03/08/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M022	03/08/2026

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

Establishment
Name	Address	ID/FEI	Business Operations
Guangzhou Shuimu Jiahe Trading Co., Ltd.		700938261	manufacture(87494-001)