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.
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:
- facial swelling
- asthma (wheezing)
- skin reddening
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
- 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: carnauba wax, FD&C blue #2, aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, purified water, talc, titanium dioxide.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.