Active Ingredients And Purpose
OTC - ACTIVE INGREDIENT SECTION
Nicotine (8 mg per pouch)
OTC - PURPOSE SECTION
Stop smoking aid
4e88dab4-8e13-f074-e063-6394a90a3908
- Set ID
- 4e88dab4-8e13-f074-e063-6394a90a3908
- Manufacturer
- Guangzhou Shuimu Jiahe Trading Co., Ltd.
- Effective date
- 2026-04-03
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 01:52:35
Key Label Information
Uses
INDICATIONS & USAGE SECTION
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, 4 mg your first cigarette within 30 minutes of waking up, use Nicotine Polacrilex Gum, 4 mg according to the following 12 week schedule: Weeks 1–6 Weeks 7–9 Weeks 10–12 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
Warnings
WARNINGS SECTION
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.
Directions And Dosage
DOSAGE & ADMINISTRATION SECTION
reduces withdrawal symptoms, including nicotine craving, associated withquitting smoking
Other Label Information
INACTIVE INGREDIENT SECTION
Microcrystalline cellulose, mannitol, propylene glycolsodium chloride, sodium bicarbonate, acesulfame, edible essence.
Products
- NICOTINE GUM
- Nicotine polacrilex
NDC Codes
Ingredients
| Name | UNII | Kind |
|---|---|---|
| TALC | 7SEV7J4R1U | IACT |
| SODIUM CARBONATE | 45P3261C7T | IACT |
| CARNAUBA WAX | R12CBM0EIZ | IACT |
| ACESULFAME POTASSIUM | 23OV73Q5G9 | IACT |
| NICOTINE | 6M3C89ZY6R | ACTIB |
| CALCIUM CARBONATE | H0G9379FGK | IACT |
| D&C YELLOW NO. 10 | 35SW5USQ3G | IACT |
| GELATIN | 2G86QN327L | IACT |
| MANNITOL | 3OWL53L36A | IACT |
| MENTHOL | L7T10EIP3A | IACT |
| SODIUM BICARBONATE | 8MDF5V39QO | IACT |
| MINT | FV98Z8GITP | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| XYLITOL | VCQ006KQ1E | IACT |
| SORBITOL | 506T60A25R | IACT |
Complete SPL Sections
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 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. 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).
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 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.
INDICATIONS & USAGE SECTION
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, 4 mg your first cigarette within 30 minutes of waking up, use Nicotine Polacrilex Gum, 4 mg according to the following 12 week schedule: Weeks 1–6 Weeks 7–9 Weeks 10–12 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
RECENT MAJOR CHANGES SECTION
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, 4 mg your first cigarette within 30 minutes of waking up, use Nicotine Polacrilex Gum, 4 mg according to the following 12 week schedule: Weeks 1–6 Weeks 7–9 Weeks 10–12 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
Source Document
Official SPL XML cached by FDA.report · DailyMed PDF
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- 2ab37ec85f09b1450a103621e393d3b41c8da44235c509a424759ca15ff9de59
- XML bytes
- 24551
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