Naproxen Sodium NAPROXEN SODIUM EQUATE (WAL-MART STORES, INC.) (SEE ALSO WAL-MART INC) FDA Approved 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
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Substance Naproxen Sodium
Route
ORAL
Applications
ANDA208363

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each capsule) Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)* *nonsteroidal anti-inflammatory drug
Inactive Ingredients
Inactive ingredients FD&C blue #1 gelatin glycerin lactic acid lecithin light mineral oil n-butyl alcohol polyethylene glycol povidone propylene glycol purified water shellac glaze sorbitan sorbitol solution titanium dioxide white ink
Strengths
220 mg 200 mg
Treats Conditions
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
Pill Appearance
Shape: capsule Color: blue Imprint: PC19

Identifiers & Packaging

Container Type BOX
UPC
0681131247979
UNII
9TN87S3A3C
Packaging

Principal Display Panel Compare to Aleve® Liquid Gels Active Ingredient** All Day Pain Relief Naproxen Sodium Capsules, 220 mg (NSAID ) Pain reliever/ Fever reducer LIQUID GELS† († Liquid-Filled Capsules) **This product is not manufactured or distributed by Bayer HealthCare, LLC distributor of Aleve® Liquid Gels. TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION. DISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716; Product Label EQUATE All Day Pain Relief Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)* *nonsteroidal anti-inflammatory drug

Package Descriptions
  • Principal Display Panel Compare to Aleve® Liquid Gels Active Ingredient** All Day Pain Relief Naproxen Sodium Capsules, 220 mg (NSAID ) Pain reliever/ Fever reducer LIQUID GELS† († Liquid-Filled Capsules) **This product is not manufactured or distributed by Bayer HealthCare, LLC distributor of Aleve® Liquid Gels. TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION. DISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716
  • Product Label EQUATE All Day Pain Relief Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)* *nonsteroidal anti-inflammatory drug

Overview

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

Indications & 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

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 if taken with food, this product may take longer to work adults and children 12 years and older take 1 capsule every 8 to 12 hours while symptoms last for the first dose you may take 2 capsules within the first hour do not exceed 2 capsules in any 8- to 12-hour period do not exceed 3 capsules 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 have 3 or more alcoholic drinks every day while using this product take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) take more or for a longer time than directed Heart attack and stroke: 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. 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, kidney disease,asthma, or had a stroke you are taking a diuretic you have problems or serious side effects from taking pain relievers or fever reducers Ask a doctor or pharmacist before use if you are under a doctor’s care for any serious condition taking aspirin for heart attack or stroke, because naproxen may decrease this benefit of aspirin taking any other drug When using this product take with food or milk if stomach upset occurs 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 leg swelling slurred speech weakness in one part or side of body pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present in the painful area any new symptoms appear you have difficulty swallowing it feels like the capsule is stuck in your throat If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use naproxen sodium at 20 weeks or later in 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 (1-800-222-1222) right away.
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 leg swelling slurred speech weakness in one part or side of body pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present in the painful area any new symptoms appear you have difficulty swallowing it feels like the capsule is stuck in your throat

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 capsule contains: sodium 20 mg store at 20-25°C (68-77°F). Avoid high humidity and excessive heat above 40°C (104°F). Protect from light. read all directions and warnings before use. Keep carton.

Questions

Questions or comments? Call 1-888-287-1915


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