Indications and uses
reduces withdrawal symptoms, including nicotine craving associated with quitting smoking
Good Sense Nicotine
- Manufacturer
- Dispensing Solutions, Inc. | PSS World Medical, Inc.
- Effective date
- 2012-03-07
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 22:31:09
Label at a glance#
ProductGood Sense Nicotine
Active ingredientNICOTINE
Label structure9 sections
Dosage and administration
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 stop smoking completely when you begin using the lozenge if you smoke your first cigarette within 30 minutes of waking up, use 4 mg nicotine lozenge if you smoke your first cigarette more than 30 minutes after waking up, use 2 mg nicotine lozeng...
Storage and handling
each lozenge contains: sodium 15 mg Phenylketonurics: Contains Phenylalanine 5.1 mg per lozenge sugar alcohol content: 1 g mannitol per lozenge store at 20-25°C (68-77°F) keep vial closed and protect from light
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient (in each lozenge)
Nicotine polacrilex, 2 mg (nicotine)
Purpose
Stop smoking aid
Uses
- reduces withdrawal symptoms, including nicotine craving associated with quitting smoking
Warnings
Enter section text here
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.
Do not use
- if you continue to smoke, chew tobacco, use snuff, or use a nicotine patch or other nicotine containing products
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 your blood pressure.
- stomach ulcer or diabetes
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 problems occur
- persistent indigestion or severe sore throat occurs
- irregular heartbeat or palpitations occur
- you get symptoms of nicotine overdose such as nausea, vomiting, dizziness, diarrhea, weakness or rapid heartbeat
Keep out of reach of children and pets.
Nicotine lozenges may have enough nicotine to make children and pets sick. If you need to remove the lozenge, wrap it in paper and throw away in the trash. In case of overdoe, get medical help or contact a Poison Control Center right away.
Directions
- 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
- stop smoking completely when you begin using the lozenge
- if you smoke your first cigarette within 30 minutes of waking up, use 4 mg nicotine lozenge
- if you smoke your first cigarette more than 30 minutes after waking up, use 2 mg nicotine lozenge according to the following 12 week schedule:
| Weeks 1 to 6 | Weeks 7 to 9 | Weeks 10 to 12 |
1 lozenge every 1 to 2 hours | 1 lozenge every 2 to 4 hours | 1 lozenge every 4 to 8 hours |
- nicotine lozenge is a medicine and must be used a certain way to get the best results
- place the lozenge in your mouth and allow the lozenge to slowly dissolve (about 20-30 minutes). Minimize swallowing. Do not chew or swallow lozenge.
- you may feel a warm or tingling sensation
- occasionally move the lozenge from one side of your mouth to the other until completely dissolved (about 20-30 minutes)
- do not eat or drink 15 minutes before using or while the lozenge is in your mouth
- to improve your chances of quitting, use at least 9 lozenges per day for the first 6 weeks
- do not use more than one lozenge at a time or continuously use one lozenge after another since this may cause you hiccups, heartburn, nausea or other side effects
- do not use more than 5 lozenges in 6 hours. Do not use more than 20 lozenges per day.
- stop using the nicotine lozenge at the end of 12 weeks. If you still feel the need to use nicotine lozenges, talk to your doctor.
Other information
- each lozenge contains: sodium 15 mg
- Phenylketonurics: Contains Phenylalanine 5.1 mg per lozenge
- sugar alcohol content: 1 g mannitol per lozenge
- store at 20-25°C (68-77°F)
- keep vial closed and protect from light
Inactive ingredients
aspartame, flavor, magnesium stearate, mannitol, potassium bicarbonate, sodium alginate, sodium carbonate, xanthan gum
Questions or comments?
call toll-free 1-866-751-9303
Principal Display Panel
NDC 68258-7991-07
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| NICOTINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| a62a50ac-1535-4461-9768-8ae703e2e9fb | Product name | 1 | 20210525 |
| 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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68258-7991-7 | 2019-11-13 | C162847 | 48780-1 | 97449f38-c20c-f6ea-e053-dbdaa90aa703 | Perrigo Nicotine Lozenge Drug Facts |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68258-7991-7 | Good Sense Nicotine | 3 in 1 CARTON | LOZENGE | 3 | 1 | |
| 68258-7991-7 | Good Sense Nicotine | 24 in 1 VIAL | LOZENGE | 24 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68258-7991 | GOOD SENSE NICOTINE (NICOTINE POLACRILEX) LOZENGE [DISPENSING SOLUTIONS, INC.] | 1 | Legacy NDC, 2 package rows | 20120313_4bb7687d-3ee0-47a3-aa43-146dede4cf55.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0113-0344-05 | EA - Each | 0113-0344 | 423381e8-6594-4512-9989-c68f50622d54 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| NICOTINE | ACTIVE INGREDIENT | 6M3C89ZY6R | 1 | |
| NICOTINE | ACTIVE MOIETY | 6M3C89ZY6R | 1 | |
| ASPARTAME | INACTIVE INGREDIENT | Z0H242BBR1 | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | 1 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | 1 | |
| POTASSIUM BICARBONATE | INACTIVE INGREDIENT | HM5Z15LEBN | 1 | |
| SODIUM ALGINATE | INACTIVE INGREDIENT | C269C4G2ZQ | 1 | |
| SODIUM CARBONATE | INACTIVE INGREDIENT | 45P3261C7T | 1 | |
| XANTHAN GUM | INACTIVE INGREDIENT | TTV12P4NEE | 1 |
Products#
Every source-derived product name is available through these pages.
- Good Sense Nicotine
- Nicotine Polacrilex
- NICOTINE
- ASPARTAME
- MAGNESIUM STEARATE
- MANNITOL
- POTASSIUM BICARBONATE
- SODIUM ALGINATE
- SODIUM CARBONATE
- XANTHAN GUM
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 68258-7991 | 68258-7991-7 |
| 0113-0344 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| NICOTINE | 6M3C89ZY6R | ACTIB |
| ASPARTAME | Z0H242BBR1 | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| MANNITOL | 3OWL53L36A | IACT |
| POTASSIUM BICARBONATE | HM5Z15LEBN | IACT |
| SODIUM ALGINATE | C269C4G2ZQ | IACT |
| SODIUM CARBONATE | 45P3261C7T | IACT |
| XANTHAN GUM | TTV12P4NEE | IACT |
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | LOZENGE / ORAL | 420 mg | ||
| SODIUM CARBONATE | SODIUM CARBONATE | 45P3261C7T | LOZENGE / ORAL | 500 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | LOZENGE / ORAL | 1264 mg | ||
| ASPARTAME | ASPARTAME | Z0H242BBR1 | LOZENGE / ORAL | 136 mg | ||
| POTASSIUM BICARBONATE | POTASSIUM BICARBONATE | HM5Z15LEBN | LOZENGE / ORAL | 80 mg | ||
| SODIUM ALGINATE | SODIUM ALGINATE | C269C4G2ZQ | LOZENGE / ORAL | 1274 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | LOZENGE / ORAL | 20546 mg |
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A077007-001 | NICOTINE POLACRILEX | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | ||
| A077007-002 | NICOTINE POLACRILEX | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A077007-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A077007-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A077007-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A077007-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077007-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077007-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077007-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077007-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077007-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077007-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077007-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077007-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077007-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077007-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077007-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077007-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077007-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077007-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077007-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077007-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077007-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077007-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A077007-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A077007-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077007-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077007-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077007-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077007-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077007-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077007-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A077007-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A077007-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077007-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077007-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A077007-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A077007-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A077007-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A077007-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A077007-001 | NICOTINE POLACRILEX | EQ 2MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A077007-002 | NICOTINE POLACRILEX | EQ 4MG BASE | TROCHE/LOZENGE / ORAL | 2006-01-31 | 74a2ff9319b5… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Good Sense Nicotine | NICOTINE POLACRILEX | L. Perrigo Company | c505dde1-2647-4c7b-99f5-9865e7c78e43 | 2024-06-18 | Warnings | 0113-0344 |
| 4b7832cb-8420-47b0-b947-363aa54e2ca1 | 4bb7687d-3ee0-47a3-aa43-146dede4cf55 | 2012-03-07 | Warnings | 4b7832cb-8420-47b0-b947-363aa54e2ca1 4bb7687d-3ee0-47a3-aa43-146dede4cf55 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.