Aleve Prescribing Information
Package insert / product label
Generic name: naproxen sodium
Dosage form: tablet
Drug class: Nonsteroidal anti-inflammatory drugs
Medically reviewed by Drugs.com. Last updated on Feb 2, 2024.
Active Ingredients(in each caplet)
Naproxen sodium 220 mg (naproxen 200 mg) (NSAID) 1
- 1
- 1 nonsteroidal anti-inflammatory drug
Indications and Usage for Aleve
- temporarily relieves minor aches and pains due to:
- minor pain of arthritis
- muscular aches
- backache
- menstrual cramps
- headache
- toothache
- the common cold
- temporarily reduces fever
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
- right before or after heart surgery
Ask a doctor before use
- the stomach bleeding warning applies to you
- 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 problems or serious side effects from taking pain relievers or fever reducers
Ask a doctor or pharmacist before use
- 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 drug
When using this product
- take with food or milk if stomach upset occurs
Stop use and ask a doctor
- 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
- fever gets worse or lasts more than 3 days
- you have difficulty swallowing
- it feels like the pill is stuck in your throat
- redness or swelling is present in the painful area
- any new symptoms appear
Keep out of reach of children.
n case of overdose, get medical help or contact a Poison Control Center right away.
If pregnant or breast-feeding,
If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use naproxen
sodium at 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.
Aleve Dosage and Administration
- do not take more than directed
- the smallest effective dose should be used
- drink a full glass of water with each dose
Adults and children 12 years and older |
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Children under 12 years |
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Storage and Handling
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
FD&C blue #2 lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, titanium dioxide
PRINCIPAL DISPLAY PANEL - 220 mg Caplet Pouch Box
ALL DAY STRONG®
ALEVE®
naproxen sodium tablets, 220 mg (NSAID)
Pain reliever/fever reducer
STRENGTH TO LAST 12 HOURS
30 POUCHES
1 PILL PER POUCH
Capsule-Shaped Tablet
Principal Display Panel- 220 mg 2 Caplet Pouch Package
ALL DAY STRONG®
ALEVE®
naproxen sodium tablets, 220 mg (NSAID)
Pain reliever/fever reducer
STRENGTH TO LAST 12 HOURS
2 Caplets
Capsule-Shaped Tablets
ALEVE
naproxen sodium tablet tablet |
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ALEVE
naproxen sodium tablet tablet |
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ALEVE
naproxen sodium tablet tablet |
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ALEVE
naproxen sodium tablet tablet |
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Labeler - Lil' Drug Store Products, Inc. (093103646) |
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