Label: NICOTINE POLACRILEX gum, chewing
- NDC Code(s): 49035-613-44
- Packager: EQUATE (Wal-Mart Stores, Inc.)
- Category: HUMAN OTC DRUG LABEL
Updated October 20, 2021
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Drug Facts
- Active ingredient (in each chewing piece)
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
- 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.
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 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.
- Other information
- Inactive ingredients
- Questions or comments?
TO INCREASE YOUR SUCCESS IN QUITTING:
- You must be motivated to quit.
- Use enough - Chew at least 9 pieces of Nicotine Polacrilex Gum per day during the first six weeks.
- Use long enough - Use Nicotine Polacrilex Gum for the full 12 weeks.
- 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
Blister packaged for your protection.
Do not use if individual seals are open or torn.
- 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.
Principal Display Panel
Compare to Nicorette® White Ice Mint® Active Ingredient*
Nicotine Polacrilex Gum USP,
4 mg (Nicotine)
Stop Smoking Aid
Includes User’s Guide
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 USP, 2 mg
4 mg coated ice mint
INGREDIENTS AND APPEARANCE
nicotine polacrilex gum, chewing
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49035-613 Route of Administration BUCCAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE 4 mg Inactive Ingredients Ingredient Name Strength ACACIA (UNII: 5C5403N26O) ACESULFAME POTASSIUM (UNII: 23OV73Q5G9) CARNAUBA WAX (UNII: R12CBM0EIZ) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH) MAGNESIUM OXIDE (UNII: 3A3U0GI71G) SODIUM BICARBONATE (UNII: 8MDF5V39QO) SODIUM CARBONATE (UNII: 45P3261C7T) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) XYLITOL (UNII: VCQ006KQ1E) Product Characteristics Color yellow Score no score Shape SQUARE Size 14mm Flavor MINT (coated ice mint) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49035-613-44 100 in 1 CARTON 10/01/2016 1 1 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA204833 10/01/2016 07/26/2024 Labeler - EQUATE (Wal-Mart Stores, Inc.) (051957769)