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Aleve PM

Generic Name: diphenhydramine hydrochloride and naproxen sodium
Date of Approval: January 16, 2014
Company: Bayer Healthcare LLC

Treatment for: Sleeplessness and Pain

FDA Approves Aleve PM

The United States Food and Drug Administration has approved Aleve PM (diphenhydramine hydrochloride and naproxen sodium), an over-the-counter antihistamine and nonsteroidal anti-inflammatory drug (NSAID) combination for the relief of occasional sleeplessness associated with minor aches and pains.

Drug Facts

Active ingredients: diphenhydramine hydrochloride 25 mg - nighttime sleep aid
naproxen sodium 220 mg (equivalent to naproxen 200 mg) - pain reliever


Aleve PM is used for the relief of occasional sleeplessness associated with minor aches and pains. It helps you to fall asleep and stay asleep.


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 using this medicine and seek medical help right away.

Stomach bleeding warning: This medicine 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 three or more alcoholic drinks every day while using this product
  • exceed the recommended dosage

Who should not use this medicine?

Do not use

  • if ever you have had an allergic reaction to any other pain reliever/fever reducer
  • unless you have time for a full night's sleep
  • in children less than 12 years of age
  • right before or after heart surgery
  • with any other product containing diphenhydramine, even one used on the skin.
  • if you have sleeplessness without pain.

Before using Aleve PM

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
  • if you have a history of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma
  • 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 any other antihistamines
  • taking any other drug

General information about Aleve PM

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
  • the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

Stop using this medicine 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
    • pain gets worse or lasts more than ten days
  • sleeplessness persists continuously for more than two weeks, as insomnia may be a sign 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 during the last three months of pregnancy unless definitely directed to do so by a doctor. It may cause problems in the unborn baby, or cause complications during delivery.

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

Directions for use

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

Other information

  • 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)
  • read all directions and warnings before use. Keep carton.

Inactive ingredients

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