Aleve Headache Pain
Naproxen Sodium · Tablet · Oral
Active ingredient
Active Ingredient Naproxen Sodium 220mg
Purpose
Purposes: Pain reliever/fever reducer
Uses
Uses : temporarily relieves minor aches and pains due to: headache minor pain of arthritis muscular aches backache menstrual cramps 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 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
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
Ask a Doctor: 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
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
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 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
Keep out of reach of children: Keep out of reach of children. In case of 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 tablet every 8 to 12 hours while symptoms last for the first dose you may take 2 tablets within the first hour do not exceed 2 tablets in any 8- to 12-hour period do not exceed 3 tablets in a 24-hour period Children under 12 years ask a doctor
Inactive ingredients
Inactive ingredient FD&C BLUE #2 LAKE, HYPROMELLOSE, MAGNESIUM STEARATE, MICROCRYSTALLINE CELLULOSE, POLYETHYLENE GLYCOL, POVIDONE, TALC, TITANIUM DIOXIDE
Questions?
Questions & comments: 1-800-395-0689 (Mon-Fri 9AM-5PM EST)
Label text from the FDA structured product label by Bayer HealthCare LLC (revised Dec 4, 2025). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Naproxen Sodium in 1 product
Aleve Headache Pain NDC products (1)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 0280-0041 | Naproxen Sodium 220 mg/1 Tablet | Bayer HealthCare LLC | NDA |
Frequently asked questions
What is Aleve Headache Pain used for?
Uses : temporarily relieves minor aches and pains due to: headache minor pain of arthritis muscular aches backache menstrual cramps toothache the common cold temporarily reduces fever
Who makes Aleve Headache Pain?
Aleve Headache Pain is listed by 1 labeler in the FDA NDC directory, including Bayer HealthCare LLC.