Aleve PM (diphenhydramine hydrochloride 25 mg naproxen sodium 220 mg) Dailymed
Generic: diphenhydramine hydrochloride and naproxen sodium is used for the treatment of Anxiety Disorders Infant, Newborn Infant, Premature Sleep Initiation and Maintenance Disorders Lactation Motion Sickness Nausea Rhinitis, Allergic, Perennial Sneezing Status Asthmaticus Urticaria Arthritis, Juvenile Arthritis, Rheumatoid Back Pain Bursitis Common Cold Dysmenorrhea Fever Gout Headache Inflammation Osteoarthritis Pain Pregnancy Trimester, Third Spondylitis, Ankylosing Toothache
IMPRINT: ALEVE PM
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COLOR: blue
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diphenhydramine hydrochloride 25 mg / naproxen sodium 220 mg oral tablet [aleve pm] - aleve pm oval blue
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Drug Facts
Otc - Active Ingredient Section
OTC - PURPOSE SECTION
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 Section
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
- bulers
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
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use naproxen sodium during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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
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"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."
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