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FDA LABEL GENERIC: Diphenhydramine MFR: Bayer HealthCare LLC.

Aleve Pm (diphenhydramine Hydrochloride 25 Mg / Naproxen Sodium 220 Mg) Oral Tablet

Drug Facts

Active ingredients (in each caplet) Purposes
Diphenhydramine hydrochloride 25 mg Nighttime sleep-aid
Naproxen sodium 220 mg (naproxen 200 mg) (NSAID) nonsteroidal anti-inflammatory drug Pain reliever

Uses

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

WARNINGS

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.

Do not use

if you have ever had an allergic reaction to any other pain reliever/fever reducer unless you have time for a full night's 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 a doctor before use if

stomach bleeding warning applies to you you have problems or serious side effects from taking pain relievers or fever reducers 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 a breathing problem such as emphysema or chronic bronchitis you have glaucoma you have trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers, or any other sleep-aid 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 antihistamines taking any other drug

When using this product

drowsiness will occur avoid alcoholic drinks do not drive a motor vehicle or operate machinery 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 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 2 weeks. Insomnia may be a symptom of a 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 a health professional before use. It is especially important not to use naproxen sodium 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 right away.

Directions

do not take more than directed drink a full glass of water with each dose adults and children 12 years and over: take 2 caplets at bedtime do not take more than 2 caplets in 24 hours if taken with food, this product may take longer to work

Other information

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

Inactive ingredients

carnauba wax, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, purified water, talc, titanium dioxide

Questions or comments?

1-800-395-0689 (Mon – Fri 9AM – 5PM EST)

PRINCIPAL DISPLAY PANEL - 20 Tablet Bottle Carton

Aleve® PM

naproxen sodium, 220 mg (NSAID)/

diphenhydramine HCl, 25 mg

Pain reliever/nighttime sleep-aid

SLEEP AID PLUS

12 HOUR PAIN RELIEVING

STRENGTH OF ALEVE

ACTUAL SIZE

20 CAPLETS

*CAPSULE-SHAPED TABLETS