Naproxen Sodium NAPROXEN SODIUM AUROHEALTH LLC FDA Approved Uses temporarily relieves minor aches and pains due to: minor pain of arthritis muscular aches menstrual cramps toothache backache headache the common cold temporarily reduces fever

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each tablet) Naproxen sodium USP 220 mg (naproxen 200 mg) (NSAID)* *nonsteroidal anti-inflammatory drug
Inactive Ingredients
Inactive ingredients colloidal silicon dioxide FD&C blue #2 aluminum lake hypromellose magnesium stearate microcrystalline cellulose polyethylene glycol povidone talc and titanium dioxide
Strengths
220 mg 200 mg
Quantities
100 tablets 100 tablet
Treats Conditions
Uses Temporarily Relieves Minor Aches And Pains Due To Minor Pain Of Arthritis Muscular Aches Menstrual Cramps Toothache Backache Headache The Common Cold Temporarily Reduces Fever
Pill Appearance
Shape: oval Color: blue Imprint: K;45

Identifiers & Packaging

Container Type BOTTLE
UNII
9TN87S3A3C
Packaging

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 220 mg (100 Tablets Bottle) AUROHEALTH NDC 58602-819-21 Naproxen Sodium Tablets, USP 220 mg (NSAID) Pain reliever Fever reducer STRENGTH TO LAST 12 HOURS 100 Tablets PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 220 mg (100 Tablet Bottle); PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 220 mg (100 Tablets Carton Label) AUROHEALTH NDC 58602-819-21 **Compare to Aleve ® active ingredient Naproxen Sodium Tablets, USP 220 mg (NSAID) Pain reliever Fever reducer STRENGTH TO LAST 12 HOURS 100 Tablets PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 220 mg (100 Tablets Carton Label)

Package Descriptions
  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 220 mg (100 Tablets Bottle) AUROHEALTH NDC 58602-819-21 Naproxen Sodium Tablets, USP 220 mg (NSAID) Pain reliever Fever reducer STRENGTH TO LAST 12 HOURS 100 Tablets PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 220 mg (100 Tablet Bottle)
  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 220 mg (100 Tablets Carton Label) AUROHEALTH NDC 58602-819-21 **Compare to Aleve ® active ingredient Naproxen Sodium Tablets, USP 220 mg (NSAID) Pain reliever Fever reducer STRENGTH TO LAST 12 HOURS 100 Tablets PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 220 mg (100 Tablets Carton Label)

Overview

Uses temporarily relieves minor aches and pains due to: minor pain of arthritis muscular aches menstrual cramps toothache backache headache the common cold temporarily reduces fever

Indications & Usage

Uses temporarily relieves minor aches and pains due to: minor pain of arthritis muscular aches menstrual cramps toothache backache headache the common cold temporarily reduces fever

Dosage & 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 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

Warnings & Precautions
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 Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.
Purpose

Purposes Pain reliever/fever reducer

Do Not Use

Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery

When Using

When using this product take with food or milk if stomach upset occurs

Stop Use & Ask a Doctor

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 you have symptoms of heart problems or stroke: chest pain trouble breathing weakness in one part or side of body slurred speech leg swelling 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

Keep Out of Reach of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Storage & Handling

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

Questions

Questions or comments? 1-855-274-4122 Distributed by: AUROHEALTH LLC 279 Princeton-Hightstown Road, East Windsor, NJ 08520 Made in India Code: TS/DRUGS/22/2009


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