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 - Purpose
Active ingredient (in each caplet)PurposeNaproxen sodium 220 mg (naproxen 200 mg) (NSAID*).............Pain reliever/
- Temporarily relieves minor aches and pains due to:minor pain of arthritisbackachethe common coldtemporarily reduces fevermuscular achesmenstrual crampsheadachetoothache
- 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
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
- 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 diseaseyou are taking a diureticyou have asthmayou 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 occursthe risk of a 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 Expirience Any Of The Following Signs Of Stomach Bleeding:
- Feel faint
- Vomit 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 feels like the pill is stuck in your throatyou develop heartburnredness or swelling is present in the painful areaany new symptoms appear
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.
Keep Out Of Reach Of Children.
In case of overdose, get medical help or contact a Poison Control Center right away.
- Do not take more than directedthe smallest effective dose should be useddo not take longer than 10 days, unless directed by a doctor (see Warnings)drink 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 tablet contains: sodium 21 mgstore at 20-25°C (68-77°F). Avoid high humidity and excessive heat above 40°C (104°F).retain carton for complete product informationTAMPER EVIDENT: Do not use if box or individual packets are broken or torn.
Croscarmellose sodium, FD&C blue #2, macrogol, magnesium stearate, polyvinyl alcohol, povidone, corn starch (pregelatinzed), talc, titanium dioxide
* Please review the disclaimer below.