Nicotine Polacrilex Gum Coated Ice Mint 4 mg ANDA204833 - Equate
Nicotine by
Drug Labeling and Warnings
Nicotine by is a Otc medication manufactured, distributed, or labeled by EQUATE (Wal-Mart Stores, Inc.). Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
NICOTINE- nicotine polacrilex gum, chewing
EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)
----------
Nicotine Polacrilex Gum Coated Ice Mint 4 mg ANDA204833 - Equate
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:
|
Weeks 1 to 6 |
Weeks 7 to 9 |
Weeks 10 to 12 |
|
1 piece every |
1 piece every |
1 piece every |
-
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.
Other information
-
each piece contains: calcium 115 mg, sodium 11 mg
-
store at 20 - 25ºC (68 - 77ºF)
-
protect from light
Inactive ingredients
acacia, acesulfame potassium, butylated hydroxytoluene, carnauba wax, FD&C red #40, gum base, hydroxypropyl cellulose, hypromellose, natural and artificial cinnamon flavors, sodium bicarbonate, sodium carbonate, sucralose, talc, titanium dioxide and xylitol.
Principal Display Panel
*Compare to the active ingredient of Nicorrette® 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
Sugar free coated nicotine gum
COATED CINNAMON 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
*This product is not manufactured or distributed by GlaxoSmithKline Consumer Healthcare, L.P., distributor of Nicorette® Gum
BLISTER PACKAGED FOR YOUR PROTECTION. DO NOT USE IF INDIVIDUAL SEALS ARE OPEN OR TORN.
DISTRIBUTED BY: Wal-Mart Inc.
Bentonville, AR 72716
| NICOTINE
nicotine polacrilex gum, chewing |
||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||
| Labeler - EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) (051957769) |
Trademark Results [Nicotine]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NICOTINE 87518792 5591301 Live/Registered |
Nicotine LLC 2017-07-07 |
 NICOTINE 75604258 not registered Dead/Abandoned |
King, Jesse 1998-12-14 |
NICOTINE 75604258 not registered Dead/Abandoned |
Brazie, Sean 1998-12-14 |
NICOTINE 75604258 not registered Dead/Abandoned |
Johnson, John 1998-12-14 |
NICOTINE 75604258 not registered Dead/Abandoned |
Crouch, Richard 1998-12-14 |
 NICOTINE 75063628 2027268 Dead/Cancelled |
ECI, INC. 1996-02-26 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.