Aleve
Naproxen Sodium
R J General Corporation
Human Otc Drug
NDC 70264-011Aleve also known as Naproxen Sodium is a human otc drug labeled by 'R J General Corporation'. National Drug Code (NDC) number for Aleve is 70264-011. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Aleve drug includes Naproxen Sodium - 220 mg/1 . The currest status of Aleve drug is Active.
Drug Information:
| Drug NDC: | 70264-011 |
| 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: | Aleve |
| 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: | Naproxen Sodium |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | R J General Corporation |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Tablet |
| 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: | NAPROXEN SODIUM - 220 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: | NDA |
| 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: | 26 Feb, 2014 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 16 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: | NDA020204 |
| 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: | R J General Corporation
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 849574
849728
|
| 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. |
| UNII: | 9TN87S3A3C
|
| 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: | Anti-Inflammatory Agents
Non-Steroidal [CS]
Cyclooxygenase Inhibitors [MoA]
Nonsteroidal Anti-inflammatory Drug [EPC]
|
| 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 |
|---|
| 70264-011-01 | 50 POUCH in 1 CARTON (70264-011-01) / 1 TABLET in 1 POUCH | 26 Feb, 2014 | 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:
Purposes pain reliever/fever reducer
Product Elements:
Aleve naproxen sodium fd&c blue no. 2 hypromellose, unspecified magnesium stearate microcrystalline cellulose polyethylene glycol, unspecified povidone, unspecified talc titanium dioxide naproxen sodium naproxen aleve
Indications and Usage:
Uses temporarily relieves minor aches and pains due to: minor pain of arthritis muscular aches backache menstrual cramps headache toothache the common cold temporarily reduces fever
Warnings:
Warnings allergy alert naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. symptoms may include: hives facial swelling asthma (wheezing) shock skin reddening rash blisters if an allergic reaction occurs, stop use and seek medical help right away. stomach bleeding warning this product contains an nsaid, which may cause severe stomach bleeding. the chance is higher if you: are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription nsaids (aspirin, ibuprofen, naproxen, or others) have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery ask a doctor before use if the stomach bleeding warning applies to you you have a history of stomach problems, s
Read more...uch as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you are taking a diuretic you have problems or serious side effects from taking pain relievers or fever reducers you have asthma ask a doctor or pharmacist before use if you are under a doctor's care for any serious condition taking any other drug when using this product take with food or milk if stomach upset occurs the risk of heart attack or stroke may increase if you use more than directed or for longer than directed stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days you have difficulty swallowing it feels like the pill is stuck in your throat redness or swelling is present in the painful area any new symptoms appear if pregnant or breast-feeding, ask a health professional before use. it is especially important not to use naproxen sodium during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. keep out of reach of children. in case of overdose, get medical help or contact a poison control center right away.
Do Not Use:
Warnings allergy alert naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. symptoms may include: hives facial swelling asthma (wheezing) shock skin reddening rash blisters if an allergic reaction occurs, stop use and seek medical help right away. stomach bleeding warning this product contains an nsaid, which may cause severe stomach bleeding. the chance is higher if you: are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription nsaids (aspirin, ibuprofen, naproxen, or others) have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery ask a doctor before use if the stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you are taking a diuretic you have problems or serious side effects from taking pain relievers or fever reducers you have asthma ask a doctor or pharmacist before use if you are under a doctor's care for any serious condition taking any other drug when using this product take with food or milk if stomach upset occurs the risk of heart attack or stroke may increase if you use more than directed or for longer than directed stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days you have difficulty swallowing it feels like the pill is stuck in your throat redness or swelling is present in the painful area any new symptoms appear if pregnant or breast-feeding, ask a health professional before use. it is especially important not to use naproxen sodium during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. keep out of reach of children. in case of overdose, get medical help or contact a poison control center right away.
When Using:
When using this product take with food or milk if stomach upset occurs the risk of heart attack or stroke may increase if you use more than directed or for longer than directed
Dosage and Administration:
Directions do not take more than directed the smallest effective dose should be used drink a full glass of water with each dose adults and children 12 years and older take 1 caplet every 8 to 12 hours while symptoms last for the first dose you may take 2 caplets within the first hour do not exceed 2 caplets in any 8- to 12-hour period do not exceed 3 caplets in a 24-hour period children under 12 years ask a doctor
Stop Use:
Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days you have difficulty swallowing it feels like the pill is stuck in your throat redness or swelling is present in the painful area any new symptoms appear
Package Label Principal Display Panel:
Principal display panel - 50 tablet pouch carton all day strong ® aleve ® naproxen sodium tablets, 220 mg (nsaid) pain reliever/fever reducer strength to last 12 hours 1 caplet capsule-shaped tablet principal display panel - 50 tablet pouch carton
Further Questions:
Questions or comments? 1-800-395-0689 (mon - fri 9am - 5pm est) or www.aleve.com