DOSAGE & ADMINISTRATION SECTION.


Directions. do not take more than directedthe smallest effective dose should be useddrink full glass of water with each doseif taken with food, this product may take longer to workadults and children 12 years and older:take capsule every to 12 hours while symptoms lastfor the first dose you may take capsules within the first hourdo not exceed capsules in any 8- to 12-hour perioddo not exceed capsules in 24-hour periodchildren under 12 years:ask doctor. do not take more than directed. the smallest effective dose should be used. drink full glass of water with each dose. if taken with food, this product may take longer to work. take capsule every to 12 hours while symptoms last. for the first dose you may take capsules within the first hour. do not exceed capsules in any 8- to 12-hour period. do not exceed capsules in 24-hour period. ask doctor.

INACTIVE INGREDIENT SECTION.


Inactive ingredients. FD&C blue 1, gelatin, glycerin, lactic acid, mannitol, pharmaceutical ink, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol.

INDICATIONS & USAGE SECTION.


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

OTC - ACTIVE INGREDIENT SECTION.


Active ingredient (in each capsule). Naproxen sodium 220 mg (naproxen 200 mg) (NSAID) nonsteroidal anti-inflammatory drug.

OTC - ASK DOCTOR SECTION.


Ask doctor before use if. stomach bleeding warning applies to youyou have history of stomach problems, such as heartburnyou have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had strokeyou are taking diureticyou have problems or serious side effects from taking pain relievers or fever reducers. stomach bleeding warning applies to you. you have history of stomach problems, such as heartburn. you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had stroke. you are taking diuretic. you have problems or serious side effects from taking pain relievers or fever reducers.

OTC - ASK DOCTOR/PHARMACIST SECTION.


Ask doctor or pharmacist before use if you are. under doctors care for any serious conditiontaking aspirin for heart attack or stroke, because naproxen may decrease this benefit of aspirintaking any other drug. under doctors care for any serious condition. taking aspirin for heart attack or stroke, because naproxen may decrease this benefit of aspirin. taking any other drug.

OTC - DO NOT USE SECTION.


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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION.


Keep out of reach of children. In case of overdose, get medical help or contact Poison Control Center right away.

OTC - PREGNANCY OR BREAST FEEDING SECTION.


If pregnant or breast-feeding, ask health professional before use. It is especially important not to use naproxen sodium during the last months of pregnancy unless definitely directed to do so by doctor because it may cause problems in the unborn child or complications during delivery.

OTC - PURPOSE SECTION.


Purposes. Pain reliever/fever reducer.

OTC - QUESTIONS SECTION.


Questions or comments. 1-888-235-2466 (Mon Fri 9AM 5PM EST).

OTC - STOP USE SECTION.


Stop use and ask doctor if. you experience any of the following signs of stomach bleeding:feel faintvomit bloodhave bloody or black stoolshave stomach pain that does not get betteryou have symptoms of heart problems or stroke:chest paintrouble breathingweakness in one part or side of bodyslurred speechleg swellingpain gets worse or lasts more than 10 daysfever gets worse or lasts more than daysredness or swelling is present in the painful areaany new symptoms appearyou have difficulty swallowingit feels like the capsule is stuck in your throat. 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 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.

OTC - WHEN USING SECTION.


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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.


PRINCIPAL DISPLAY PANEL 220 mg Capsule Bottle Carton. Compare to ALEVE (R) Liquid Gels active ingredient ++ NDC 0363-0177-11Naproxen SodiumCAPSULES, 220 mg (NSAID) /PAIN RELIEVER FEVER REDUCER12 HOUR LIQUID GELS20 LIQUID-FILLED CAPSULES(LIQUID GELS). 40s Count.

SPL UNCLASSIFIED SECTION.


Drug Facts.

STORAGE AND HANDLING SECTION.


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

WARNINGS SECTION.


Warnings. Allergy alert: Naproxen sodium may cause severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hivesfacial swellingasthma (wheezing)shockskin reddeningrashblistersIf an allergic reaction occurs, stop use and seek medical help right away.. hives. facial swelling. asthma (wheezing). shock. skin reddening. rash. blisters. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: are age 60 or olderhave had stomach ulcers or bleeding problemstake blood thinning (anticoagulant) or steroid drugtake other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)have or more alcoholic drinks every day while using this producttake more or for longer time than directed. are age 60 or older. have had stomach ulcers or bleeding problems. take blood thinning (anticoagulant) or steroid drug. take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others). have or more alcoholic drinks every day while using this product. take more or for 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. Do not use. if you have ever had an allergic reaction to any other pain reliever/fever reducerright before or after heart surgery. if you have ever had an allergic reaction to any other pain reliever/fever reducer. right before or after heart surgery. Ask doctor before use if. stomach bleeding warning applies to youyou have history of stomach problems, such as heartburnyou have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had strokeyou are taking diureticyou have problems or serious side effects from taking pain relievers or fever reducers. stomach bleeding warning applies to you. you have history of stomach problems, such as heartburn. you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had stroke. you are taking diuretic. you have problems or serious side effects from taking pain relievers or fever reducers. Ask doctor or pharmacist before use if you are. under doctors care for any serious conditiontaking aspirin for heart attack or stroke, because naproxen may decrease this benefit of aspirintaking any other drug. under doctors 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. take with food or milk if stomach upset occurs. Stop use and ask doctor if. you experience any of the following signs of stomach bleeding:feel faintvomit bloodhave bloody or black stoolshave stomach pain that does not get betteryou have symptoms of heart problems or stroke:chest paintrouble breathingweakness in one part or side of bodyslurred speechleg swellingpain gets worse or lasts more than 10 daysfever gets worse or lasts more than daysredness or swelling is present in the painful areaany new symptoms appearyou have difficulty swallowingit feels like the capsule is stuck in your throat. 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 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 health professional before use. It is especially important not to use naproxen sodium during the last months of pregnancy unless definitely directed to do so by 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 Poison Control Center right away.