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NDC 70000-0341-01 Nicotine Polacrilex 4 mg/1 Details

Nicotine Polacrilex 4 mg/1

Nicotine Polacrilex is a BUCCAL GUM, CHEWING in the HUMAN OTC DRUG category. It is labeled and distributed by Cardinal Health (Leader) 70000. 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: 70000-0341-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Nicotine Gum

Product Information

NDC	70000-0341
Product ID	70000-0341_0d78ef05-d996-4dc3-b144-2b8c4ced1c0a
Associated GPIs	62100010002820
GCN Sequence Number	013486
GCN Sequence Number Description	nicotine polacrilex GUM 4 MG BUCCAL
HIC3	J3A
HIC3 Description	SMOKING DETERRENT AGENTS (GANGLIONIC STIM,OTHERS)
GCN	03201
HICL Sequence Number	002049
HICL Sequence Number Description	NICOTINE POLACRILEX
Brand/Generic	Generic
Proprietary Name	Nicotine Polacrilex
Proprietary Name Suffix	Original
Non-Proprietary Name	Nicotine Polacrilex
Product Type	HUMAN OTC DRUG
Dosage Form	GUM, CHEWING
Route	BUCCAL
Active Ingredient Strength	4
Active Ingredient Units	mg/1
Substance Name	NICOTINE
Labeler Name	Cardinal Health (Leader) 70000
Pharmaceutical Class	Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA074707
Listing Certified Through	2024-12-31

Package

Package Images

NDC 70000-0341-01 (70000034101)

Pricing Information
NDC Package Code	70000-0341-1
Billing NDC	70000034101
Package	50 BLISTER PACK in 1 CARTON (70000-0341-1) / 1 GUM, CHEWING in 1 BLISTER PACK
Marketing Start Date	2018-07-03
NDC Exclude Flag	N
Price Per Unit	0.31287
Pricing Unit	EA
Effective Date	2024-02-21
NDC Description	NICOTINE 4 MG CHEWING GUM
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	1
Classification for Rate Setting	G
As of Date	2024-02-21

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL 4acbda22-9c87-49f2-ad5f-55b1e54bdf2e Details

Drug Facts

Active ingredient (in each chewing piece) - 2 mg

Nicotine polacrilex 2 mg (nicotine)

Active ingredient (in each chewing piece) - 4 mg

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 - 2 mg

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.

Directions - 4 mg

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 - 2 mg

each piece contains: calcium 115 mg, sodium 11 mg
store at 20 - 25ºC (68 - 77ºF)
protect from light

Other information - 4 mg

each piece contains: calcium 110 mg, sodium 11 mg
store at 20 - 25ºC (68 - 77ºF)
protect from light

Inactive ingredients - 2 mg

acesulfame potassium, butylated hydroxytoluene, carnauba wax, flavors, gum base, sodium bicarbonate, sodium carbonate, sorbitol and talc.

Inactive ingredients - 4 mg

acesulfame potassium, butylated hydroxytoluene, carnauba wax, D&C yellow #10 lake, FD&C blue #2 lake, FD&C red #40, FD&C yellow #6 lake, flavors, gum base, sodium bicarbonate, sodium carbonate, sorbitol and talc.

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal display panel 2 mg

COMPARE TO NICORETTE® ORIGINAL GUM active ingredient*

Sugar-Free

Nicotine Gum

Nicotine Polacrilex Gum USP, 2 mg Nicotine

Stop Smoking Aid

2 mg

Original Flavor

For Those Who Smoke Their First Cigarette More Than 30 Minutes After Waking Up

If You Smoke Their First Cigarette WITHIN 30 Minutes of Waking Up, Use Nicotine Polacrilex Gum USP,4 mg

TO INCREASE YOUR SUCCESS IN QUITTING:

1. You Must be motivated 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

not for sale to those under 18 years of age
proof of age required
not for sale in vending machine 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® Original Gum.

BLISTER PACKAGED FOR YOUR PROTECTION. DO NOT USE IF INDIVIDUAL SEALS ARE OPEN OR TORN.

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

Package label 2 mg

LEADER Sugar Free Nicotine Gum

Principal display panel 4 mg

COMPARE TO NICORETTE® ORIGINAL GUM active ingredient*

Sugar-Free

Nicotine Gum

Nicotine Polacrilex Gum USP, 4 mg (Nicotine)

Stop Smoking Aid

4 mg

Original Flavor

For Those Who Smoke Their First Cigarette With 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

TO INCREASE YOUR SUCCESS IN QUITTING:

1. You must be motivated 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

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® Original Gum.

BLISTER PACKAGED FOR YOUR PROTECTION. DO NOT USE IF INDIVIDUAL SEALS ARE OPEN OR TORN.

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

Package label 4 mg

LEADER Sugar Free Nicotine Gum

INGREDIENTS AND APPEARANCE

NICOTINE POLACRILEX ORIGINAL

nicotine polacrilex gum, chewing

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70000-0345
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
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CARNAUBA WAX (UNII: R12CBM0EIZ)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM CARBONATE (UNII: 45P3261C7T)
SORBITOL (UNII: 506T60A25R)
TALC (UNII: 7SEV7J4R1U)

Product Characteristics
Color	white (off white to tan)	Score	no score
Shape	SQUARE	Size	14mm
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70000-0345-1	50 in 1 CARTON	07/03/2018
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	ANDA074507	07/03/2018

NICOTINE POLACRILEX ORIGINAL

nicotine polacrilex gum, chewing

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70000-0341
Route of Administration	BUCCAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R)	NICOTINE	4 mg

Ingredient Name	Strength
Inactive Ingredients
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CARNAUBA WAX (UNII: R12CBM0EIZ)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM CARBONATE (UNII: 45P3261C7T)
SORBITOL (UNII: 506T60A25R)
TALC (UNII: 7SEV7J4R1U)

Product Characteristics
Color	yellow	Score	no score
Shape	SQUARE	Size	14mm
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70000-0341-1	50 in 1 CARTON	07/03/2018
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	ANDA074707	07/03/2018

Labeler - Cardinal Health (Leader) 70000 (063997360)

Revised: 9/2021

Document Id: 0d78ef05-d996-4dc3-b144-2b8c4ced1c0a

Set id: 4acbda22-9c87-49f2-ad5f-55b1e54bdf2e

Version: 8

Effective Time: 20210928

Search by Drug Name or NDC

NDC 70000-0341-01 Nicotine Polacrilex 4 mg/1 Details

Nicotine Polacrilex 4 mg/1

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 70000-0341-01 (70000034101)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 4acbda22-9c87-49f2-ad5f-55b1e54bdf2e Details

Drug Facts

Active ingredient (in each chewing piece) - 2 mg

Active ingredient (in each chewing piece) - 4 mg

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 - 2 mg

Directions - 4 mg

Other information - 2 mg

Other information - 4 mg

Inactive ingredients - 2 mg

Inactive ingredients - 4 mg

Questions or comments?

Principal display panel 2 mg

Package label 2 mg

Principal display panel 4 mg

Package label 4 mg

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