NDC 51655-624 Naproxen Sodium

NDC Product Code 51655-624

NDC CODE: 51655-624

Proprietary Name: Naproxen Sodium 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.

Non-Proprietary Name: What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • See also Warning section. Naproxen is used to relieve pain from various conditions such as headache, muscle aches, tendonitis, dental pain, and menstrual cramps. It also reduces pain, swelling, and joint stiffness caused by arthritis, bursitis, and gout attacks. This medication is known as a nonsteroidal anti-inflammatory drug (NSAID). It works by blocking your body's production of certain natural substances that cause inflammation. If you are treating a chronic condition such as arthritis, ask your doctor about non-drug treatments and/or using other medications to treat your pain. Check the ingredients on the label even if you have used the product before. The manufacturer may have changed the ingredients. Also, products with similar names may contain different ingredients meant for different purposes. Taking the wrong product could harm you.

NDC Code Structure

  • 51655 - Northwind Pharmaceuticals, Llc

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.

NDC Product Information

Naproxen Sodium with NDC 51655-624 is a product labeled by Northwind Pharmaceuticals, Llc. The generic name of Naproxen Sodium is . The product's dosage form is and is administered via form.

Labeler Name: Northwind Pharmaceuticals, Llc

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Northwind Pharmaceuticals, Llc
Labeler Code: 51655
Start Marketing Date: 07-14-2014 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: I - INACTIVATED, the listing data was inactivated by the FDA. 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".

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Information for Patients

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),...
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Naproxen Sodium 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

Indications And Usage

Active ingredient (in each tablet)Naproxen sodium 220 mg(naproxen 200 mg) (NSAID)**nonsteroidal anti-inflammatory drugPurposePain reliever/fever reducerUses•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

WarningsAllergy 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•blistersIf 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 directedDo not use•if you have ever had an allergic reaction to any other pain reliever/fever reducer•right before or after heart surgeryAsk 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 asthmaAsk a doctor or pharmacist before use if you are•under a doctor’s care for any serious condition•taking any other drugWhen 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 directedStop 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 appearIf 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 doseAdults 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 periodChildren under 12 years:•ask a doctorOther 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 ingredientsFD&C blue no. 2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, titanium dioxide

Label

NDC: 51655-624-24MFG: 45802-490-78Naproxen Sodium 220 MG24 TabletsOTCLot#Exp. Date:Each tablet contains naproxen sodium....220 mgSodium....21 mgDosage: See prescribing information.Store at 68 to 77 degrees FStore in a tight, light-resistant container. Protect from moisture.Keep out of the reach of children.Distributed by: Perrigo, Allergan, MI 49010Lot#Repackaged by Northwind Pharmaceuticals, Indianapolis, IN 46256

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