NDC 0135-0626 Nicorette

Nicotine Polacrilex

NDC Product Code 0135-0626

NDC 0135-0626-01

Package Description: 1 CONTAINER in 1 CARTON > 20 LOZENGE in 1 CONTAINER

NDC 0135-0626-02

Package Description: 4 CONTAINER in 1 CARTON > 20 LOZENGE in 1 CONTAINER

NDC Product Information

Nicorette with NDC 0135-0626 is a a human over the counter drug product labeled by Glaxosmithkline Consumer Healthcare Holdings (us) Llc. The generic name of Nicorette is nicotine polacrilex. The product's dosage form is lozenge and is administered via oral form.

Labeler Name: Glaxosmithkline Consumer Healthcare Holdings (us) Llc

Dosage Form: Lozenge - A solid preparation containing one or more medicaments, usually in a flavored, sweetened base which is intended to dissolve or disintegrate slowly in the mouth. A lollipop is a lozenge on a stick.

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 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 4 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)
  • HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • MANNITOL (UNII: 3OWL53L36A)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • SODIUM CARBONATE (UNII: 45P3261C7T)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • POLACRILIN (UNII: RCZ785HI7S)
  • ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
  • HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • MANNITOL (UNII: 3OWL53L36A)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • SODIUM CARBONATE (UNII: 45P3261C7T)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • XANTHAN GUM (UNII: TTV12P4NEE)

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.

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: NDA021330 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: 05-01-2019 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: 12-31-2019 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.

Nicorette Product Label Images

Nicorette 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 Lozenge) (2 Mg)

Nicotine polacrilex, 2 mg

Active Ingredient (In Each Lozenge) (4 Mg)

Nicotine polacrilex, 4 mg

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

  • •heart disease, recent heart attack, or irregular heartbeat. Nicotine can increase your heart rate. •high blood pressure not controlled with medication. Nicotine can increase your 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 problems occur •persistent indigestion or severe sore throat occurs •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.

Nicotine lozenges may have enough nicotine to make children and pets sick. If you need to remove the lozenge, wrap it 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. No studies have been done to show if this product will work for you. •before using this product, read the enclosed User’s Guide for complete directions and other important information •begin using the lozenge on your quit day •if you smoke your first cigarette within 30 minutes of waking up, use 4 mg nicotine lozenge •if you smoke your first cigarette more than 30 minutes after waking up, use 2 mg nicotine lozenge according to the following 12 week schedule:Weeks 1 to 6Weeks 7 to 9Weeks 10 to 121 lozenge every 1 to 2 hours1 lozenge every 2 to 4 hours1 lozenge every 4 to 8 hours •nicotine lozenge is a medicine and must be used a certain way to get the best results •place the lozenge in your mouth and allow the lozenge to slowly dissolve. Minimize swallowing. Do not chew or swallow lozenge. •you may feel a warm or tingling sensation •occasionally move the lozenge from one side of your mouth to the other until completely dissolved •do not eat or drink 15 minutes before using or while the lozenge is in your mouth •to improve your chances of quitting, use at least 9 lozenges per day for the first 6 weeks •do not use more than one lozenge at a time or continuously use one lozenge after another since this may cause you hiccups, heartburn, nausea or other side effects •do not use more than 5 lozenges in 6 hours. Do not use more than 20 lozenges per day. •it is important to complete treatment. If you feel you need to use the lozenge 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. No studies have been done to show if this product will work for you. •before using this product, read the enclosed User’s Guide for complete directions and other important information •begin using the lozenge on your quit day •if you smoke your first cigarette more than 30 minutes after waking up, use 2 mg nicotine lozenge •if you smoke your first cigarette within 30 minutes of waking up, use 4 mg nicotine lozenge according to the following 12 week schedule:Weeks 1 to 6Weeks 7 to 9Weeks 10 to 121 lozenge every 1 to 2 hours1 lozenge every 2 to 4 hours1 lozenge every 4 to 8 hours •nicotine lozenge is a medicine and must be used a certain way to get the best results •place the lozenge in your mouth and allow the lozenge to slowly dissolve. Minimize swallowing. Do not chew or swallow lozenge. •you may feel a warm or tingling sensation •occasionally move the lozenge from one side of your mouth to the other until completely dissolved •do not eat or drink 15 minutes before using or while the lozenge is in your mouth •to improve your chances of quitting, use at least 9 lozenges per day for the first 6 weeks •do not use more than one lozenge at a time or continuously use one lozenge after another since this may cause you hiccups, heartburn, nausea or other side effects •do not use more than 5 lozenges in 6 hours. Do not use more than 20 lozenges per day. •it is important to complete treatment. If you feel you need to use the lozenge for a longer period to keep from smoking, talk to your health care provider.

Other Information (Ice Mint)

  • •store at 20 - 25°C (68 - 77°F) •Store in the original container

Inactive Ingredients (Ice Mint)

Acesulfame potassium, flavors, hypromellose, magnesium stearate, mannitol, microcrystalline cellulose, polysorbate 80, potassium aluminum silicate, sodium carbonate, xanthan gum

* Please review the disclaimer below.

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