NDC 51655-624 Naproxen Sodium

NDC Product Code 51655-624

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

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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