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 ingredients (in each tablet)PurposesNaproxen Sodium 220 mg (naproxen 200 mg) (NSAID)*Pain reliever/fever reducer*nonsteroidal anti-inflammatory drug
■ temporarily relieves minor aches and pains due to: ■ minor pain of arthritis ■ muscular aches ■ backache ■ headache ■ menstrual cramps ■ toothache ■ the common cold■ temporarily reduces fever
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 ■ blistersIf 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
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 If
■ 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, or kidney disease■ you are taking a diuretic ■ you have problems or serious side effects from taking pain relievers or fever reducers■ you have asthma
When Using This Product
■ take with food or milk if stomach upset occurs■ the 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 the following signs of stomach bleeding: ■ feel faint ■ vomit blood ■ have bloody or black stools ■ have stomach pain that does not get better■ 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
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 (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
■ do not take more than directed■ the smallest effective dose should be used■ drink a full glass of water with each doseAdults and children ■ take 1 tablet every 8 to 12 hours while symptoms last 12 years and older ■ 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 periodChildren under 12 years ■ ask a doctor
■ each tablet contains: sodium 20 mg■ store at 20-25°C (68-77°F). Avoid high humidity and excessive heat above 40°C (104°F)
FD&C blue#2 aluminum lake, hypromellose 2910, maize starch, microcrystalline cellulose, polyethylene glycol, povidone k-30, sodium starch glycolate, stearic acid, titanium dioxide
* Please review the disclaimer below.