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.
Active Ingredient (In Each Caplet)
Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)**nonsteroidal anti-inflammatory drug
Pain reliever/fever reducer
- Temporarily relieves minor aches and pains due to:
- Minor pain of arthritismuscular achesbackachemenstrual crampsheadachetoothachethe common coldtemporarily reduces fever
- 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 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 reducerright before or after heart surgery
Ask A Doctor Before Use If
- The stomach bleeding warning applies to youyou have a history of stomach problems, such as heartburnyou have high blood pressure, heart disease, liver cirrhosis, or kidney disease, asthma, or had a strokeyou are taking a diureticyou have problems or serious side effects from taking pain relievers or fever reducers
Ask A Doctor Or Pharmacist Before Use If You Are
- Under a doctor's care for any serious conditiontaking any other drug
When Using This Product
- Take with food or milk if stomach upset occurs
Stop Use And Ask A Doctor If
- Side effects occur. You may report side effects to FDA at
- You experience any of the following signs of stomach bleeding: o feel faint o vomit blood o have bloody or black stools o have stomach pain that does not get betteryou have symptoms of heart problems or stroke: o chest pain
- O trouble breathing
- O weakness in one part or side of body
- O slurred speech
- O leg swelling
- Pain 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)
- Do not take more than directedthe smallest effective dose should be useddrink a full glass of water with each doseAdults and children 12 years and oldertake 1 caplet every 8 to 12 hours while symptoms lastfor the first dose you may take 2 caplets within the first hourdo not exceed 2 caplets in any 8- to 12-hour perioddo not exceed 3 caplets in a 24-hour periodChildren under 12 yearsask a doctor
- Each caplet contains: sodium 21 mg
- Store at 20-25°C (68-77°F). Avoid high humidity and excessive heat above 40°C (104°F).
Croscarmellose sodium, FD&C blue #1, FD&C blue #2, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, talc and titanium dioxide.
* Please review the disclaimer below.