Nicotine
Nicotine Polacrilex
Quality Choice (chain Drug Marketing Association)
Human Otc Drug
NDC 63868-845Nicotine also known as Nicotine Polacrilex is a human otc drug labeled by 'Quality Choice (chain Drug Marketing Association)'. National Drug Code (NDC) number for Nicotine is 63868-845. This drug is available in dosage form of Gum, Chewing. The names of the active, medicinal ingredients in Nicotine drug includes Nicotine - 2 mg/1 . The currest status of Nicotine drug is Active.
Drug Information:
| Drug NDC: | 63868-845 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Nicotine |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Nicotine Polacrilex |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Quality Choice (chain Drug Marketing Association) |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Gum, Chewing |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | NICOTINE - 2 mg/1
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | BUCCAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | ANDA |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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. |
| Marketing Start Date: | 31 Dec, 2020 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 15 Jan, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | ANDA204794 |
| 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. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | QUALITY CHOICE (Chain Drug Marketing Association)
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 314119
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UPC: | 0635515998148
|
| UPC stands for Universal Product Code. |
| NUI: | N0000175706
M0014836
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | 6M3C89ZY6R
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class EPC: | Cholinergic Nicotinic Agonist [EPC]
|
| Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`. |
| Pharmacologic Class CS: | Nicotine [CS]
|
| Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient]. |
| Pharmacologic Class: | Cholinergic Nicotinic Agonist [EPC]
Nicotine [CS]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 63868-845-20 | 20 BLISTER PACK in 1 CARTON (63868-845-20) / 1 GUM, CHEWING in 1 BLISTER PACK | 31 Dec, 2020 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purpose stop smoking aid
Product Elements:
Nicotine nicotine polacrilex nicotine nicotine acacia acesulfame potassium carnauba wax hydroxypropyl cellulose, unspecified magnesium oxide sodium bicarbonate sodium carbonate talc titanium dioxide xylitol
Indications and Usage:
Use reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking
Warnings:
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.
Dosage and Administration:
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
Read more... 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.
Stop Use:
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)
Package Label Principal Display Panel:
Principal display panel - 2 mg *compare to the active ingredient of nicorette® gum nicotine gum stop smoking aid nicotine polacrilex gum usp, 2 mg (nicotine) 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, 4 mg sugar free coated ice mint flavor 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. blister packaged for your protection. do not use if individual seal 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. *this product is not manufactured or distributed by glaxosmithkline consumer healthcare, l.p., distributor of nicorette® gum. distributed by c.d.m.a., inc.© 43157 w 9 mile rd novi, mi 48375 www.qualitychoice.com
Package label quality choice nicotine gum coated ice mint flavor nicotine polacrilex 2 mg (nicotine)
Further Questions:
Questions or comments? call 1-800-935-2362 monday-friday 9am-5pm est