NDC 51655-624 Naproxen Sodium

Product Information

Product Code51655-624
Proprietary Name 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.
Naproxen Sodium
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Northwind Pharmaceuticals, Llc
Labeler Code51655
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
07-14-2014
Listing Expiration Date 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.
12-31-2019
Exclude Flag 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
I
NDC Code Structure

Usage Information


Product Characteristics

Color(s)BLUE (C48333)
ShapeROUND (C48348)
Size(s)10 MM
Imprint(s)L490
Score1

Product Packages

NDC 51655-624-24

Package Description: 24 TABLET in 1 BOTTLE, DISPENSING

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Product Details

Naproxen Sodium is product labeled by Northwind Pharmaceuticals, Llc. The product's dosage form is and is administered via form.


What are Naproxen Sodium Active Ingredients?

The following is the list of active ingredients in this product. An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

  • NAPROXEN SODIUM (UNII: 9TN87S3A3C)
  • NAPROXEN (UNII: 57Y76R9ATQ) (Active Moiety)


NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct code indicates a single concept unique identifier (RXCUI) is associated with this product:


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Patient Education

Naproxen

Naproxen is pronounced as (na prox' en)

Why is naproxen medication prescribed?
Prescription naproxen is used to relieve pain, tenderness, swelling, and stiffness caused by osteoarthritis (arthritis caused by a breakdown of the lining of the joints),...
[Read More]

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Naproxen Sodium Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Indications And Usage



Active ingredient (in each tablet)

Naproxen sodium 220 mg

(naproxen 200 mg) (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

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, 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. (1-800-222-1222)


Dosage



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 tablet every 8 to 12 hours while symptoms last
•for the first dose you may take 2 tablets within the first hour
•do not exceed 2 tablets in any 8- to 12-hour period
•do not exceed 3 tablets in a 24-hour period

Children under 12 years:

•ask a doctor

Other information

•each tablet contains: sodium 21 mg
•store at 20-25°C (68-77°F). Avoid high humidity and excessive heat above 40°C (104°F).

Inactive ingredients

FD&C blue no. 2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, titanium dioxide


Label



NDC: 51655-624-24

MFG: 45802-490-78

Naproxen Sodium 220 MG

24 Tablets

OTC

Lot#

Exp. Date:

Each tablet contains naproxen sodium....220 mg

Sodium....21 mg

Dosage: See prescribing information.

Store at 68 to 77 degrees F

Store in a tight, light-resistant container. Protect from moisture.

Keep out of the reach of children.

Distributed by: Perrigo, Allergan, MI 49010

Lot#

Repackaged by Northwind Pharmaceuticals, Indianapolis, IN 46256


* Please review the disclaimer below.