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NDC 49035-0512-44 Nicotine Polacrilex 2 mg/1 Details

Nicotine Polacrilex 2 mg/1

Nicotine Polacrilex is a BUCCAL GUM, CHEWING in the HUMAN OTC DRUG category. It is labeled and distributed by EQUATE (Wal-Mart Stores, Inc.). The primary component is NICOTINE.

MedlinePlus Drug Summary

Nicotine chewing gum is used to help people stop smoking cigarettes. Nicotine chewing gum should be used together with a smoking cessation program, which may include support groups, counseling, or specific behavioral change techniques. Nicotine gum is in a class of medications called smoking cessation aids. It works by providing nicotine to your body to decrease the withdrawal symptoms experienced when smoking is stopped and as a substitute oral activity to reduce the urge to smoke.

Related Packages: 49035-0512-44
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Nicotine Gum

Product Information

NDC	49035-0512
Product ID	49035-512_43c699c4-a278-4ac7-a705-18ea03c16248
Associated GPIs	46300030100132
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Nicotine Polacrilex
Proprietary Name Suffix	Coated Ice Mint
Non-Proprietary Name	Nicotine Polacrilex
Product Type	HUMAN OTC DRUG
Dosage Form	GUM, CHEWING
Route	BUCCAL
Active Ingredient Strength	2
Active Ingredient Units	mg/1
Substance Name	NICOTINE
Labeler Name	EQUATE (Wal-Mart Stores, Inc.)
Pharmaceutical Class	Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA204794
Listing Certified Through	n/a

Package

Package Images

NDC 49035-0512-44 (49035051244)

Pricing Information	N/A
NDC Package Code	49035-512-44
Billing NDC	49035051244
Package	100 BLISTER PACK in 1 CARTON (49035-512-44) / 1 GUM, CHEWING in 1 BLISTER PACK
Marketing Start Date	2016-10-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 180af7f0-d7af-4f64-99ce-a4357b821836 Details

Active ingredient (in each chewing piece)

Nicotine polacrilex 2 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 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 within 30 minutes of waking up, use 4 mg nicotine gum

• if you smoke your first cigarette more than 30 minutes after waking up, use 2 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

• each piece contains: calcium 115 mg, sodium 8 mg

• store at 20 - 25ºC (68 - 77ºF)

• protect from light

Inactive ingredients

acacia, acesulfame potassium, carnauba wax, flavors, gum base, hydroxypropyl cellulose, magnesium oxide, sodium bicarbonate, sodium carbonate, talc, titanium dioxide and xylitol.

Questions or comments?

Call 1-888-287-1915

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.

instructions

• 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.

FREE AUDIO CD Upon Request. See inside.

PRINCIPAL DISPLAY PANEL

NDC 49035-612-44

equate™

Compare to Nicorette® White Ice Mint® Active Ingredient*

Coated

Nicotine

Gum

Nicotine Polacrilex Gum USP,

2 mg (Nicotine)

Stop Smoking Aid

Includes User's Guide

FOR THOSE WHO SMOKE THEIR

FIRST CIGARETTE MORE THAN

30 MINUTES AFTER WAKING UP.

If you smoke your first cigarette

WITHIN 30 MINUTES of waking up,

use Nicotine Polacrilex Gum USP, 4 mg

Ice Mint

Flavor

2 mg 100 PIECES

INGREDIENTS AND APPEARANCE

NICOTINE POLACRILEX COATED ICE MINT

nicotine polacrilex gum, chewing

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49035-512
Route of Administration	BUCCAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R)	NICOTINE	2 mg

Ingredient Name	Strength
Inactive Ingredients
ACACIA (UNII: 5C5403N26O)
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
CARNAUBA WAX (UNII: R12CBM0EIZ)
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	white	Score	no score
Shape	SQUARE (biconvex)	Size	14mm
Flavor	MINT	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:49035-512-44	100 in 1 CARTON	10/01/2016
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA204794	10/01/2016	07/26/2024

Labeler - EQUATE (Wal-Mart Stores, Inc.) (051957769)

Revised: 10/2021

Document Id: 43c699c4-a278-4ac7-a705-18ea03c16248

Set id: 180af7f0-d7af-4f64-99ce-a4357b821836

Version: 3

Effective Time: 20211020