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.
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Otc - Active Ingredient
Naproxen sodium 220 mg(naproxen 200 mg) (NSAID)**nonsteroidal anti-inflammatory drug
Otc - Purpose
Pain reliever/fever reducer
- Temporarily relieves minor aches and pain due to :backacheheadachemenstrul crampsminor pain of arthritismuscular achesthe common coldtoothachetemporarily reduces fever
- Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:asthma (wheezing)blistersfacial swellinghivesrashshockskin reddeningIf an allergic reaction occurs, stop use and seek medical help right away.
Stomach Bleeding Warning
- This product contains a non steroidal anti-inflammatory drug(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
NSAID's except aspirin increases 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 surgery
Ask A Doctor Before Use If
- The stomach bleeding warning applies to youyou have a history of stomach problems,such as a heartburnyou have a high blood pressure, heart disease, liver cirrhosis or kidney diseaseyou are taking a diureticyou have problems or serious side effects taking pain relievers or fever reducersyou have asthma
Ask A Doctor Or Pharmacist Before Use If You Are
- Under a doctor 's care for any serious conditionstaking any other drug
When Using This Product
- Take with food or milk if stomach upset occursthe risk of heart attack or stroke may increase if you use more than directed or for longer than directed
Stop Use And Ask A Doctor If
- You experience any of following sign of stomach bleeding:feel faintvomit bloodhave bloody or black stoolshave stomach pain that does not get betterpain gets worse or lasts more than 10 daysfever gets worse or lasts more than 3 daysyou have difficulty swallowingit feel 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 profession 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 complication during the delivery.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a position control center right away (1-800-222-1222)
- 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 one tablet every 8 to 12 hours while symptoms lastfor the first dose you may take within the first hourdo not exceed 2 tablets in any 8 to 12 hours perioddo not exceed 3 tablets in 24 hour period Children under 12 years:
- Ask a doctor
- Each tablet contains: sodium 20 mg
- Store between 20°-25°C(68-77°F). Avoid high humidity and excessive heat above 40°C(104°F)
Colloidal silicon dioxide*, croscarmellose sodium*, FD&C Blue#2 lake, hypromellose, magnesium stearate*, maize starch*, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate*, stearic acid*, titanium dioxide.*contains one or more of these ingredients
* Please review the disclaimer below.