Berkley And Jensen Nicotine
Nicotine Polacrilex
Bjwc
Human Otc Drug
NDC 68391-957Berkley And Jensen Nicotine also known as Nicotine Polacrilex is a human otc drug labeled by 'Bjwc'. National Drug Code (NDC) number for Berkley And Jensen Nicotine is 68391-957. This drug is available in dosage form of Lozenge. The names of the active, medicinal ingredients in Berkley And Jensen Nicotine drug includes Nicotine - 4 mg/1 . The currest status of Berkley And Jensen Nicotine drug is Active.
Drug Information:
| Drug NDC: | 68391-957 |
| 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: | Berkley And Jensen 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: | Bjwc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Lozenge |
| 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 - 4 mg/1
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | ORAL
|
| 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: | 06 Nov, 2017 |
| 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: | ANDA203690 |
| 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: | BJWC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 359818
|
| 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: | 0012345678905
|
| 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 |
|---|
| 68391-957-01 | 27 LOZENGE in 1 BOTTLE (68391-957-01) | 06 Nov, 2017 | N/A | No |
| 68391-957-06 | 7 BOTTLE in 1 PACKAGE (68391-957-06) / 27 LOZENGE in 1 BOTTLE | 06 Nov, 2017 | 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:
Berkley and jensen nicotine nicotine polacrilex nicotine nicotine polacrilin acesulfame potassium calcium polycarbophil magnesium stearate mannitol potassium bicarbonate sodium alginate sodium carbonate sucralose xanthan gum white to off-white l957
Indications and Usage:
Use reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking
Warnings:
Warnings
Dosage and Administration:
Directions 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 users 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 6 weeks 7 to 9 weeks 10 to 12 1 lozenge every 1 to 2 hours 1 lozenge every 2 to 4 hours 1 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
Read more... 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.
Stop Use:
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 or rapid heartbeat you have symptoms of an allergic reaction (such as difficulty breathing or rash)
Package Label Principal Display Panel:
Package/label principal display panel compare to the active ingredient in nicorette® mini lozenge mini nicotine lozenge nicotine polacrilex lozenge 4mg (nicotine) stop smoking aid includes users guide quittube® for those who smoke their first cigarette within 30 minutes of waking up. if you smoke your first cigarette more than 30 minutes after waking up, use nicotine polacrilex lozenge, 2 mg mint actual size 100% money-back guarantee 189 lozenges 4mg each (7 mini quittube® containers of 27) 4mg 957-d3-mini nicotine lozenge-1.jpg 957-d3-mini nicotine lozenge-2.jpg
Further Questions:
Questions or comments? call toll-free 1-866-751-9303