Bayer Aleve
Naproxen Sodium · Tablet · Oral
Active ingredient
Active ingredient (in each caplet) Naproxen Sodium 220 mg (naproxen 200 mg) (NSAID)* *nonsteroidal anti-inflammatory drug
Purpose
Purposes Pain reliever/fever reducer
Uses
Uses 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
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 stomach ulcers or bleeding problems take a blood thinner (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: NSAID,s 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
Do not use if you ever have had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery
Ask a doctor before use
Ask a doctor before use if 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
Ask a doctor or pharmacist before use if you are 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
When using this product take with food or milk if stomach upset occurs
Stop use and ask a doctor
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 for more than 10 days fever gets worse or lasts for 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
Pregnancy 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 specifically 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
Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.
Directions
Directions 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) take 1 caplet every 8 to 12 hours while symptoms last for the first dose you may take 2 caplets within the first hour do not exceed 2 caplets in any 8 to 12- hour period do not exceedc3 caplets in a 24- hour period. Children under 12 years: ask a doctor
Inactive ingredients
Inactive ingredients Colliodal silicon dioxide, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, mannitol, polyethylene glycol, sodium starch glycolate, stearic acid, titanium dioxide
Questions?
Questions or comments? 1-800-395-0689 (Mon-Fri 9AM-5PM EST)
Label text from the FDA structured product label by Unifirst First Aid Corporation (revised Sep 9, 2025). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Naproxen Sodium in 2 products
Bayer Aleve NDC products (2)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 0924-6000 | Naproxen Sodium 220 mg/1 Tablet | Acme United Corporation | NDA |
| 47682-488 | Naproxen Sodium 220 mg/1 Tablet | Unifirst First Aid Corporation | NDA |
Frequently asked questions
What is Bayer Aleve used for?
Uses 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
Who makes Bayer Aleve?
Bayer Aleve is listed by 2 labelers in the FDA NDC directory, including Acme United Corporation, Unifirst First Aid Corporation.