DOSAGE & ADMINISTRATION SECTION.


Directions. do not take more than directeddrink full glass of water with each doseadults and children 12 years and over: take caplets at bedtimedo not take more than caplets in 24 hoursif taken with food, this product may take longer to work. do not take more than directed. drink full glass of water with each dose. adults and children 12 years and over: take caplets at bedtime. do not take more than caplets in 24 hours. if taken with food, this product may take longer to work.

INULLCTIVE INGREDIENT SECTION.


Inactive ingredients. carnauba wax, FD&C blue aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, purified water, talc, titanium dioxide.

INDICATIONS & USAGE SECTION.


Uses. for relief of occasional sleeplessness when associated with minor aches and painshelps you fall asleep and stay asleep. for relief of occasional sleeplessness when associated with minor aches and pains. helps you fall asleep and stay asleep.

OTC - ACTIVE INGREDIENT SECTION.


Active ingredients (in each caplet)PurposesDiphenhydramine hydrochloride 25 mgNighttime sleep-aidNaproxen sodium 220 mg (naproxen 200 mg) (NSAID) nonsteroidal anti-inflammatory drug Pain reliever.

OTC - ASK DOCTOR SECTION.


Ask doctor before use if. stomach bleeding warning applies to youyou have problems or serious side effects from taking pain relievers or fever reducersyou 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 breathing problem such as emphysema or chronic bronchitisyou have glaucomayou have trouble urinating due to an enlarged prostate gland. stomach bleeding warning applies to you. you have problems or serious side effects from taking pain relievers or fever reducers. 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 breathing problem such as emphysema or chronic bronchitis. you have glaucoma. you have trouble urinating due to an enlarged prostate gland.

OTC - ASK DOCTOR/PHARMACIST SECTION.


Ask doctor or pharmacist before use if you are. taking sedatives or tranquilizers, or any other sleep-aidunder doctors care for any serious conditiontaking aspirin for heart attack or stroke, because naproxen may decrease this benefit of aspirintaking any other antihistaminestaking any other drug. taking sedatives or tranquilizers, or any other sleep-aid. 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 antihistamines. 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 reducerunless you have time for full nights sleepin children under 12 years of ageright before or after heart surgerywith any other product containing diphenhydramine, even one used on skinif you have sleeplessness without pain. if you have ever had an allergic reaction to any other pain reliever/fever reducer. unless you have time for full nights sleep. in children under 12 years of age. right before or after heart surgery. with any other product containing diphenhydramine, even one used on skin. if you have sleeplessness without pain.

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 - PREGNULLNCY 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.


Active ingredients (in each caplet)PurposesDiphenhydramine hydrochloride 25 mgNighttime sleep-aidNaproxen sodium 220 mg (naproxen 200 mg) (NSAID) nonsteroidal anti-inflammatory drug Pain reliever.

OTC - QUESTIONS SECTION.


Questions or comments. 1-800-395-0689 (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 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 dayssleeplessness persists continuously for more than weeks. Insomnia may be symptom of serious underlying medical illness.redness or swelling is present in the painful areaany new symptoms appearyou have difficulty swallowingit feels like the pill is stuck in your throat. 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. sleeplessness persists continuously for more than weeks. Insomnia may be symptom of serious underlying medical illness.. redness or swelling is present in the painful area. any new symptoms appear. you have difficulty swallowing. it feels like the pill is stuck in your throat.

OTC - WHEN USING SECTION.


When using this product. drowsiness will occuravoid alcoholic drinksdo not drive motor vehicle or operate machinerytake with food or milk if stomach upset occurs. drowsiness will occur. avoid alcoholic drinks. do not drive motor vehicle or operate machinery. take with food or milk if stomach upset occurs.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.


PRINCIPAL DISPLAY PANEL 20 Tablet Bottle Carton. Aleve(R) PMnaproxen sodium, 220 mg (NSAID)/diphenhydramine HCl, 25 mgPain reliever/nighttime sleep-aidSLEEP AID PLUS12 HOUR PAIN RELIEVINGSTRENGTH OF ALEVE20 CAPLETSCAPSULE-SHAPED TABLETS. Aleve PM carton.

SPL UNCLASSIFIED SECTION.


Drug Facts.

STORAGE AND HANDLING SECTION.


Other information. read all warnings and directions before use. Keep outer carton.each caplet contains: sodium 20 mg store at 20-25C (68-77F)avoid high humidity and excessive heat above 40C (104F). read all warnings and directions before use. Keep outer carton.. each caplet contains: sodium 20 mg store at 20-25C (68-77F). avoid high humidity and excessive heat above 40C (104F).

WARNINGS SECTION.


Warnings. Allergy alertNaproxen 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 warningThis 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 warningNSAIDs, 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 reducerunless you have time for full nights sleepin children under 12 years of ageright before or after heart surgerywith any other product containing diphenhydramine, even one used on skinif you have sleeplessness without pain. if you have ever had an allergic reaction to any other pain reliever/fever reducer. unless you have time for full nights sleep. in children under 12 years of age. right before or after heart surgery. with any other product containing diphenhydramine, even one used on skin. if you have sleeplessness without pain. Ask doctor before use if. stomach bleeding warning applies to youyou have problems or serious side effects from taking pain relievers or fever reducersyou 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 breathing problem such as emphysema or chronic bronchitisyou have glaucomayou have trouble urinating due to an enlarged prostate gland. stomach bleeding warning applies to you. you have problems or serious side effects from taking pain relievers or fever reducers. 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 breathing problem such as emphysema or chronic bronchitis. you have glaucoma. you have trouble urinating due to an enlarged prostate gland. Ask doctor or pharmacist before use if you are. taking sedatives or tranquilizers, or any other sleep-aidunder doctors care for any serious conditiontaking aspirin for heart attack or stroke, because naproxen may decrease this benefit of aspirintaking any other antihistaminestaking any other drug. taking sedatives or tranquilizers, or any other sleep-aid. 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 antihistamines. taking any other drug. When using this product. drowsiness will occuravoid alcoholic drinksdo not drive motor vehicle or operate machinerytake with food or milk if stomach upset occurs. drowsiness will occur. avoid alcoholic drinks. do not drive motor vehicle or operate machinery. 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 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 dayssleeplessness persists continuously for more than weeks. Insomnia may be symptom of serious underlying medical illness.redness or swelling is present in the painful areaany new symptoms appearyou have difficulty swallowingit feels like the pill is stuck in your throat. 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. sleeplessness persists continuously for more than weeks. Insomnia may be symptom of serious underlying medical illness.. redness or swelling is present in the painful area. any new symptoms appear. you have difficulty swallowing. it feels like the pill 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.