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Topcare Nicotine
Nicotine Polacrilex · Gum, Chewing
Overview
Active ingredients
Source: NDC DirectoryForms, strengths and routes
Source: NDC DirectoryPharmacologic classes are listed in the class section below.
Pharmacologic class
Source: NDC Directory| Class | Type | Browse |
|---|---|---|
| Cholinergic Nicotinic Agonist [EPC] | EPC | All 61 members |
| Nicotine [CS] | CS | All 61 members |
Regulatory status
Source: Drugs@FDANDC Directory| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 206394-001 | NICOTINE POLACRILEX | GUM, CHEWING | NICOTINE POLACRILEX | Over-the-counter | — |
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Supplement | 14 | Labeling | Approved | September 21, 2023 | Standard |
| Supplement | 13 | Manufacturing (CMC) | Approved | January 6, 2022 | Unknown |
| Supplement | 9 | Manufacturing (CMC) | Approved | April 24, 2020 | — |
| Supplement | 4 | Manufacturing (CMC) | Approved | July 23, 2018 | Unknown |
| Original application | 1 | Approved | December 15, 2016 | Standard |
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260630). This is the manufacturer's labelling text, not a summary and not advice.
Indications and Usage
openFDA Drug LabelingUse • reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking
Purpose
openFDA Drug LabelingPurpose Stop smoking aid
Dosage and Administration
openFDA Drug LabelingDirections • 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, 2 mg • if you smoke your first cigarette within 30 minutes of waking up, use Nicotine Polacrilex Gum, 4 mg according to the following 12 week schedule: Weeks 1 to 6 Weeks 7 to 9 Weeks 10 to 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 • it is important to complete treatment. If you feel you need to use the gum for a longer period to keep from smoking, talk to your health care provider.
Warnings
openFDA Drug LabelingWarnings 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. 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. • stomach ulcer or diabetes • history of seizures 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) Keep out of reach of children and pets. Pieces of nicotine gum may have enough nicotine to make children and pets sick. Wrap used pieces of gum in paper and throw away in the trash. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Ask a Doctor
openFDA Drug LabelingAsk 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. • stomach ulcer or diabetes • history of seizures
Stop Use
openFDA Drug LabelingStop 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)
Active Ingredient
openFDA Drug LabelingActive ingredient (in each chewing piece) Nicotine polacrilex (equal to 2 mg nicotine)
Adverse event reports
Source: openFDA FAERSAttributed to this product's most-reported active ingredient: NICOTINE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.
Packaging and NDCs
Source: NDC Directory| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 36800-029-25 | 36800-029 | Topco Associates LLC | 110 BLISTER PACK in 1 CARTON (36800-029-25) / 1 GUM, CHEWING in 1 BLISTER PACK | April 20, 2005 |
| 36800-170-25 | 36800-170 | Topco Associates LLC | 110 BLISTER PACK in 1 CARTON (36800-170-25) / 1 GUM, CHEWING in 1 BLISTER PACK | April 20, 2005 |
| 36800-269-78 | 36800-269 | Topco Associates LLC | 100 BLISTER PACK in 1 CARTON (36800-269-78) / 1 GUM, CHEWING in 1 BLISTER PACK | December 6, 2019 |
| 36800-456-60 | 36800-456 | Topco Associates LLC | 20 BLISTER PACK in 1 CARTON (36800-456-60) / 1 GUM, CHEWING in 1 BLISTER PACK | February 6, 2013 |
| 36800-456-78 | 36800-456 | Topco Associates LLC | 100 BLISTER PACK in 1 CARTON (36800-456-78) / 1 GUM, CHEWING in 1 BLISTER PACK | December 18, 2006 |
| 36800-460-25 | 36800-460 | Topco Associates LLC | 110 BLISTER PACK in 1 CARTON (36800-460-25) / 1 GUM, CHEWING in 1 BLISTER PACK | July 28, 2023 |
| 36800-532-60 | 36800-532 | Topco Associates LLC | 20 BLISTER PACK in 1 CARTON (36800-532-60) / 1 GUM, CHEWING in 1 BLISTER PACK | January 23, 2013 |
| 36800-532-78 | 36800-532 | Topco Associates LLC | 100 BLISTER PACK in 1 CARTON (36800-532-78) / 1 GUM, CHEWING in 1 BLISTER PACK | October 30, 2006 |
| 36800-650-60 | 36800-650 | Topco Associates LLC | 20 BLISTER PACK in 1 CARTON (36800-650-60) / 1 GUM, CHEWING in 1 BLISTER PACK | February 13, 2017 |
| 36800-650-78 | 36800-650 | Topco Associates LLC | 100 BLISTER PACK in 1 CARTON (36800-650-78) / 1 GUM, CHEWING in 1 BLISTER PACK | February 13, 2017 |
| 36800-863-78 | 36800-863 | Topco Associates LLC | 100 BLISTER PACK in 1 CARTON (36800-863-78) / 1 GUM, CHEWING in 1 BLISTER PACK | February 13, 2017 |
| 36800-967-78 | 36800-967 | Topco Associates LLC | 100 BLISTER PACK in 1 CARTON (36800-967-78) / 1 GUM, CHEWING in 1 BLISTER PACK | December 6, 2019 |
| 36800-029 | 36800-029 | Topco Associates LLC | — | April 20, 2005 |
| 36800-170 | 36800-170 | Topco Associates LLC | — | April 19, 2005 |
| 36800-269 | 36800-269 | Topco Associates LLC | — | December 6, 2019 |
| 36800-456 | 36800-456 | Topco Associates LLC | — | December 18, 2006 |
| 36800-460 | 36800-460 | Topco Associates LLC | — | July 28, 2023 |
| 36800-532 | 36800-532 | Topco Associates LLC | — | October 30, 2006 |
| 36800-650 | 36800-650 | Topco Associates LLC | — | February 13, 2017 |
| 36800-863 | 36800-863 | Topco Associates LLC | — | February 13, 2017 |
| 36800-967 | 36800-967 | Topco Associates LLC | — | December 6, 2019 |
Sources for this page
| Dataset | Agency | Used for |
|---|---|---|
| NDC Directory | FDA | Identity, ingredients, strengths, forms, routes, labelers, packages |
| Drugs@FDA | FDA | Application, sponsor, submissions, review documents, marketing status |
| Drug Labeling | FDA / NLM | Prescribing information reproduced above |
| FAERS | FDA | Adverse event report counts |
Generated September 25, 2026 · 11 sections on this page.