DOSAGE & ADMINISTRATION SECTION
reduces withdrawal symptoms, including nicotine craving, associated withquitting smoking
reduces withdrawal symptoms, including nicotine craving, associated withquitting smoking
Microcrystalline cellulose, mannitol, propylene glycolsodium chloride, sodium bicarbonate, acesulfame, edible essence.
Nicotine (8 mg per pouch)
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
Stop smoking aid
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.
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.
| Class | Version | Type | Effective |
|---|---|---|---|
| NICOTINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| fb7ab793-2c12-4079-b100-a64f73bef25a | Product name | 4 | 20240712 |
| b0cbf770-6cc3-4aa4-9158-755110c2b9f7 | Product name | 2 | 20230717 |
| dc7c5daa-021f-40dd-b00d-63982cb2067a | Product name | 1 | 20230426 |
| a62a50ac-1535-4461-9768-8ae703e2e9fb | Product name | 1 | 20210525 |
| 08ffbcbf-26df-b99c-1dab-64fc4cfae89f | Product name | 5 | 20200925 |
| 816b97af-edc5-4060-aff1-b814bdbcad50 | Product name | 1 | 20190415 |
| 7cda52fc-125f-421c-8fea-bc1974370c49 | Product name | 2 | 20180703 |
| 419aab54-5d5a-4146-9453-026d4a9991be | Product name | 2 | 20170525 |
| 08ffbcbf-26df-b99c-1dab-64fc4cfae89f | Product name | 2 | 20160823 |
| 89dac932-b90a-4410-9ab1-84c53e57de25 | Product name | 1 | 20150316 |
| 9514609b-a2a9-f8ec-6ba6-3f8e5ee89877 | Product name | 1 | 20140508 |
| bc07ef78-e82d-0c19-31f4-31f263780582 | Product name | 1 | 20140508 |
| dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562 | Product name | 1 | 20140508 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 87494-001-01 | NICOTINE Oral Pouch | 45 mg in 1 BOX, UNIT-DOSE | LOZENGE | 45 | 2 | |
| 87494-001-02 | NICOTINE Oral Pouch | 3 in 1 BOX | LOZENGE | 3 | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 87494-001 | 87494-001-01, 87494-001-02 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SODIUM BICARBONATE | 8MDF5V39QO | IACT |
| NICOTINE | 6M3C89ZY6R | ACTIB |
| CEFATRIZINE PROPYLENE GLYCOLATE | 3731IA5GI9 | IACT |
| ACESULFAME | MA3UYZ6K1H | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| FLAVOR SPICE MINT N&A110589 | KG6KU384XW | IACT |
| MANNITOL | 3OWL53L36A | IACT |
| SODIUM CHLORIDE | 451W47IQ8X | IACT |
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 1 | 2026-03-08 | monthly-update | 2026-06-03 17:58:34 |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 58618c2b-b944-b310-e063-6394a90a38a4 | 4c853456-51ef-abf3-e063-6394a90aa4ce | 2026-08-06 | Warnings | 4c853456-51ef-abf3-e063-6394a90aa4ce |
Adverse event summaries are temporarily unavailable. Other product information remains available.