NDC 0135-0157 Nicorette Original

Nicotine Polacrilex

NDC Product Code 0135-0157

NDC CODE: 0135-0157

Proprietary Name: Nicorette Original What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Nicotine Polacrilex What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication can help you quit smoking by replacing the nicotine in cigarettes. The nicotine in tobacco is an important part of cigarette addiction. When you stop smoking, your nicotine levels drop quickly. This drop can cause withdrawal symptoms such as craving tobacco, nervousness, irritability, headache, weight gain, and difficulty concentrating. Stopping smoking is hard and your chance of success is best when you are ready and have made a commitment to quit. Nicotine replacement products are part of a total stop-smoking program that includes behavior change, counseling, and support. Smoking causes lung disease, cancer, and heart disease. Stopping smoking is one of the most important things you can do to improve your health and live longer.

NDC Code Structure

NDC 0135-0157-07

Package Description: 1 BLISTER PACK in 1 CARTON > 110 GUM, CHEWING in 1 BLISTER PACK

NDC 0135-0157-10

Package Description: 1 BLISTER PACK in 1 CARTON > 170 GUM, CHEWING in 1 BLISTER PACK

NDC 0135-0157-11

Package Description: 1 BLISTER PACK in 1 CARTON > 200 GUM, CHEWING in 1 BLISTER PACK

NDC Product Information

Nicorette Original with NDC 0135-0157 is a a human over the counter drug product labeled by Glaxosmithkline Consumer Healthcare Holdings (us) Llc. The generic name of Nicorette Original is nicotine polacrilex. The product's dosage form is gum, chewing and is administered via oral form.

Labeler Name: Glaxosmithkline Consumer Healthcare Holdings (us) Llc

Dosage Form: Gum, Chewing - A sweetened and flavored insoluble plastic material of various shapes which when chewed, releases a drug substance into the oral cavity.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Nicorette Original Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • NICOTINE 2 mg/1

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • POLACRILIN (UNII: RCZ785HI7S)
  • ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
  • CARNAUBA WAX (UNII: R12CBM0EIZ)
  • HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
  • MAGNESIUM OXIDE (UNII: 3A3U0GI71G)
  • MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
  • PEPPERMINT OIL (UNII: AV092KU4JH)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • SODIUM BICARBONATE (UNII: 8MDF5V39QO)
  • SODIUM CARBONATE (UNII: 45P3261C7T)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • XYLITOL (UNII: VCQ006KQ1E)
  • POLACRILIN (UNII: RCZ785HI7S)
  • ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
  • CARNAUBA WAX (UNII: R12CBM0EIZ)
  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
  • ALUMINUM OXIDE (UNII: LMI26O6933)
  • HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
  • MAGNESIUM OXIDE (UNII: 3A3U0GI71G)
  • MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
  • PEPPERMINT OIL (UNII: AV092KU4JH)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • SODIUM CARBONATE (UNII: 45P3261C7T)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • XYLITOL (UNII: VCQ006KQ1E)
  • POLACRILIN (UNII: RCZ785HI7S)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • SODIUM BICARBONATE (UNII: 8MDF5V39QO)
  • SODIUM CARBONATE (UNII: 45P3261C7T)
  • SORBITOL (UNII: 506T60A25R)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.
  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Glaxosmithkline Consumer Healthcare Holdings (us) Llc
Labeler Code: 0135
FDA Application Number: NDA018612 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: NDA - A product marketed under an approved New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 06-29-2009 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Information for Patients

Nicotine Gum

Nicotine Gum is pronounced as (nik' oh teen)

Why is nicotine gum medication prescribed?
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 supp...
[Read More]

* Please review the disclaimer below.

Nicorette Original Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredient (In Each Chewing Piece)

Nicotine polacrilex (equal to 2 mg nicotine)Nicotine polacrilex (equal to 4 mg nicotine)

Purpose

Stop smoking aid

Use

  • •reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking

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 A Pharmacist Before Use If You Are

  • •using a non-nicotine stop smoking drug •taking a 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 •(For Cinnamon Surge) oral blistering occurs •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 (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 6Weeks 7 to 9 Weeks 10 to 121 piece every 1 to 2 hours1 piece every 2 to 4 hours1 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 6Weeks 7 to 9 Weeks 10 to 121 piece every 1 to 2 hours1 piece every 2 to 4 hours1 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 (White Ice Mint)

  • •(2 mg) each piece contains: calcium 94 mg, sodium 11 mg •(4 mg) each piece contains: calcium 94 mg, sodium 13 mg •store at 20 - 25oC (68 - 77oF) •protect from light

Other Information (Original)

  • •each piece contains: calcium 117 mg, sodium 13 mg •store at 20 - 25oC (68 - 77oF) •protect from light

Other Information (Cinnamon Surge)

  • •(2 mg) each piece contains: calcium 94 mg, sodium 11 mg •(4 mg) each piece contains: calcium 94 mg, sodium 13 mg •store at 20 - 25oC (68 - 77oF) •protect from light

Other Information (Fresh Mint)

  • •(2 mg) each piece contains: calcium 94 mg, sodium 11 mg •(4 mg) each piece contains: calcium 94 mg, sodium 13 mg •store at 20 - 25oC (68 - 77oF) •protect from light

Other Information (Mint)

  • •(2 mg) each piece contains: calcium 94 mg, sodium 13 mg •(4 mg) each piece contains: calcium 94 mg, sodium 14 mg •store at 20 - 25oC (68 - 77oF) •protect from light

Other Information (Spearmint Burst)

  • •(2 mg) each piece contains: calcium 94 mg, sodium 11 mg •(4 mg) each piece contains: calcium 94 mg, sodium 13 mg •store at 20 - 25oC (68 - 77oF) •protect from light

Inactive Ingredients (White Ice Mint)

Each 2 mg piece contains: acesulfame potassium, carnauba wax, edible ink, flavor, gum base, hypromellose, magnesium oxide, menthol, peppermint oil, polysorbate 80, sodium bicarbonate, sodium carbonate, starch, sucralose, titanium dioxide, xylitol each 4 mg piece contains: acesulfame potassium, carnauba wax, D&C yellow #10 Al. lake, edible ink, flavor, gum base, hypromellose, magnesium oxide, menthol, peppermint oil, polysorbate 80, sodium carbonate, starch, sucralose, titanium dioxide, xylitol

Inactive Ingredients (Original)

Each 2 mg piece contains: flavors, glycerin, gum base, sodium bicarbonate, sodium carbonate, sorbitoleach 4 mg piece contains: D&C yellow #10, flavors, glycerin, gum base, sodium carbonate, sorbitol

Inactive Ingredients (Cinnamon Surge)

Each 2 mg piece contains: acacia, acesulfame potassium, carnauba wax, edible ink, gum base, hypromellose, magnesium oxide, menthol, natural and artificial cinnamon flavors, peppermint oil, polysorbate 80, sodium bicarbonate, sodium carbonate, sucralose, titanium dioxide, xylitol each 4 mg piece contains: acacia, acesulfame potassium, carnauba wax, D&C yellow #10 Al. lake, edible ink, gum base, hypromellose, magnesium oxide, menthol, natural and artificial cinnamon flavors, peppermint oil, polysorbate 80, sodium carbonate, sucralose, titanium dioxide, xylitol

Inactive Ingredients (Fresh Mint)

Each 2 mg piece contains: acacia, acesulfame potassium, carnauba wax, edible ink, gum base, magnesium oxide, menthol, peppermint oil, sodium bicarbonate, sodium carbonate, titanium dioxide, xylitol each 4 mg piece contains: acacia, acesulfame potassium, carnauba wax, D&C yellow #10 Al. lake, edible ink, gum base, magnesium oxide, menthol, peppermint oil, sodium carbonate, titanium dioxide, xylitol

Inactive Ingredients (Mint)

Each 2 mg piece contains: acesulfame potassium, gum base, magnesium oxide, menthol, peppermint oil, sodium bicarbonate, sodium carbonate, xylitol each 4 mg piece contains: acesulfame potassium, D&C yellow #10 Al. lake, gum base, magnesium oxide, menthol, peppermint oil, sodium carbonate, xylitol

Inactive Ingredients (Spearmint Burst)

Each 2 mg piece contains: acacia, acesulfame potassium, carnauba wax, edible ink, flavors, gum base, hypromellose, magnesium oxide, menthol, peppermint oil, polysorbate 80, sodium bicarbonate, sodium carbonate, sucralose, titanium dioxide, xylitoleach 4 mg piece contains: acacia, acesulfame potassium, carnauba wax, D&C yellow #10 Al. lake, edible ink, flavors, gum base, hypromellose, magnesium oxide, menthol, peppermint oil, polysorbate 80, sodium carbonate, sucralose, titanium dioxide, xylitol

Additional Information Found On Packaging

  • TO INCREASE YOUR SUCCESS IN QUITTING: 1.You must be motivated to quit.2.Use Enough – Chew at least 9 pieces of Nicorette gum per day during the first six weeks.3.Use Long Enough – Use Nicorette 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 verifiedThis product is protected in sealed blisters. Do not use if individual blisters or printed backings are broken, open, or torn.Distributed byGSK Consumer HealthcareWarren, NJ 07059Made in SwedenFor more information and for a FREE individualized stop smoking program, please visit www.Nicorette.com or see inside for more details.

* Please review the disclaimer below.