OTC - ASK DOCTOR/PHARMACIST SECTION.

Ask doctor or pharmacist before use 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.

DOSAGE & ADMINISTRATION SECTION.

Directions: do not take more than directedthe smallest effective dose should be useddrink full glass of water with each doseAdults and children 12 years and oldertake tablet every to 12 hours while symptoms lastfor the first dose you may take tablets within the first hourdo not exceed tablets in any 8- to 12-hour perioddo not exceed tablets in 24-hour periodChildren under 12 yearsask doctor. do not take more than directed. the smallest effective dose should be used. drink full glass of water with each dose. take tablet every to 12 hours while symptoms last. for the first dose you may take tablets within the first hour. do not exceed tablets in any 8- to 12-hour period. do not exceed tablets in 24-hour period. ask doctor.

INACTIVE INGREDIENT SECTION.

Inactive ingredient. FD&C BLUE LAKE, HYPROMELLOSE, MAGNESIUM STEARATE, MICROCRYSTALLINE CELLULOSE, POLYETHYLENE GLYCOL, POVIDONE, TALC, TITANIUM DIOXIDE.

INDICATIONS & USAGE SECTION.

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

OTHER SAFETY INFORMATION.

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

OTC - ACTIVE INGREDIENT SECTION.

Active Ingredient Naproxen Sodium 220mg.

OTC - ASK DOCTOR SECTION.

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

OTC - PURPOSE SECTION.

Purposes:. Pain reliever/fever reducer.

OTC - QUESTIONS SECTION.

Questions comments: 1-800-395-0689 (Mon-Fri 9AM-5PM EST).

OTC - STOP USE SECTION.

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

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.

ALL DAY STRONG(R)ALEVEHEADACHE PAINnaproxen sodium tablets, 220 mg (NSAID)Pain reliever/fever reducerBayerFor temporary relief of headache painACTUAL SIZESTRENGTH TO LAST 12 HOURSTABLETS. Aleve Headache Carton.

PREGNANCY SECTION.

The pregnancy/breast-feeding warning: 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.

SPL UNCLASSIFIED SECTION.

Dist. by :Bayer Healthcare LLCWhippany, NJ 07981.

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.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 directedHeart 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. hives. facial swelling. asthma (wheezing). shock. skin reddening. rash. blisters. 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.