The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active ingredient (in each caplet)
Naproxen sodium 220 mg
(naproxen 200 mg) (NSAID)*
Otc - Purpose
Pain reliever/fever reducer
Indications & Usage
- Usestemporarily relieves minor aches and pains due to:minor pain of arthritis
- Muscular aches
- Menstrual cramps
- The common cold
- Temporarily reduces fever
- WarningsAllergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
- Hivesfacial swellingasthma (wheezing)shockskin reddeningrashblistersIf 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 olderhave had stomach ulcers or bleeding problemstake a blood thinning (anticoagulant) or steroid drugtake other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)have 3 or more alcoholic drinks every day while using this producttake more or for a longer time than directedHeart 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.
Otc - Do Not Use
- Do not useif you have ever had an allergic reaction to any other pain reliever/fever reducerright before or after heart surgery
Otc - Ask Doctor
- Ask a doctor before use ifthe stomach bleeding warning applies to youyou have a history of stomach problems, such as heartburnyou have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a strokeyou are taking a diureticyou have problems or serious side effects from taking pain relievers or fever reducers
Otc - Ask Doctor/Pharmacist
- Ask a doctor or pharmacist before use if you areunder a doctor’s care for any serious conditiontaking aspirin for heart attack or stroke, beacuse naproxen may decrease this benefit of aspirintaking any other drug
Otc - When Using
- When using this producttake with food or milk if stomach upset occurs
Otc - Stop Use
- Stop use and ask a doctor ifyou experience any of the following signs of stomach bleeding:feel faintvomit bloodhave bloody or black stoolshave stomach pain that does not get betteryou have symptoms of heart problems or stroke:chest paintrouble breathingweakness in one part or side of bodyslurred speechleg swellingpain gets worse or lasts more than 10 daysfever gets worse or lasts more than 3 daysyou have difficulty swallowingit feels like the pill is stuck in your throatredness or swelling is present in the painful areaany new symptoms appear
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use naproxen sodium during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
Otc - 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 (1-800-222-1222).
Dosage & Administration
- Directionsdo not take more than directedthe smallest effective dose should be useddrink a full glass of water with each doseAdults and children 12 years and older:take 1 tabet every 8 to 12 hours while symptoms lastfor the first dose you may take 2 tablets within the first hourdo not exceed 2 tablets in any 8- to 12-hour perioddo not exceed 3 tablets in a 24-hour periodChildren under 12 years:
- Ask a doctor
- Other informationeach tablet 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 colloidal silicon dioxide, croscarmellose sodium, FD&C blue no. 2 lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, titanium dioxide
Otc - Questions
Questions or comments? 1-800-632-6900
* Please review the disclaimer below.