FDA Label for Nicotine
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH CHEWING PIECE)
- PURPOSE
- USE
- WARNINGS
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- STOP USE AND ASK A DOCTOR IF
- KEEP OUT OF REACH OF CHILDREN AND PETS.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
- PACKAGE LABEL
Nicotine Product Label
The following document was submitted to the FDA by the labeler of this product P & L Development, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient (In Each Chewing Piece)
Nicotine Polacrilex 4 mg (nicotine)
Purpose
Stop smoking aid
Use
- reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking
Warnings
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 (1-800-222-1222) 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
begin using the gum on your quit day
if you smoke your first cigarette more than 30 minutes after waking up, use 2 mg nicotine gum
if you smoke your first cigarette within 30 minutes of waking up, use 4 mg nicotine gum according to the following 12 week schedule:
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.
Weeks 1 to 6 | Weeks 7 to 9 | Weeks 10 to 12 |
1 piece every | 1 piece every | 1 piece every |
Other Information
- each piece contains: calcium 115 mg, sodium 8 mg
- store at 20 - 25°C (68 - 77°F)
- protect from light
Inactive Ingredients
acacia, acesulfame potassium, carnauba wax, D&C yellow #10, FD&C blue #2, FD&C red #40, FD&C yellow #6, flavors, gum base, hydroxypropyl cellulose, magnesium oxide, sodium bicarbonate, sodium carbonate, sucralose, talc, titanium dioxide, xylitol.
Questions Or Comments?
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Principal Display Panel
*Compare to the active ingredient in Nicorette® Gum
nicotine Gum
nicotine polacrilex gum USP, 4 mg (nicotine)
stop smoking aid
FOR THOSE WHO SMOKE THEIR FIRST CIGARETTE WITHIN 30 MINUTES OF WAKING UP
If you smoke your first cigarette MORE THAN 30 MINUTES after waking up, use Nicotine Polacrilex gum, 2 mg
4 mg
sugar-free
coated fruit flavor
TO INCREASE YOUR SUCCESS IN QUITTING:
1. You must be motivate to quit
2. Use Enough - Chew at least 9 pieces of Nicotine Polacrilex Gum per day during the first six weeks
3. Use long enough - Use Nicotine Polacrilex Gum for the full 12 weeks
4. Use with a Support Program as directed in the enclosed User's Guide
To remove the gum, tear off single unit
Peel off backing starting at corner with loose edge
Push gum through foil
- not for sale to those under 18 years of age
- proof of age required
- not for sale in vending machines or from any source where proof of age cannot be verified
BLISTER PACKAGED FOR YOUR PROTECTION. DO NOT USE IF INDIVIDUAL SEALS ARE OPEN OR TORN.
*This product is not manufactured or distributed by Haleon Group of Companies, distributor of Nicorette® Gum.
Distributed by: PL Developments
200 Hicks Street, Westbury, NY 11590
Package Label
WELLNESS BASICS Nicotine Gum Coated Fruit Flavor
* Please review the disclaimer below.