FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
Indications And Usage
Active ingredient (in each tablet)
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 arthritis
•the common cold
•temporarily reduces fever
Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
If 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
Ask a doctor or pharmacist before use if you are
•under a doctor’s care for any serious condition
•taking any other drug
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:
•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
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. (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 1 tablet every 8 to 12 hours while symptoms last
•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 period
Children under 12 years:
•ask a doctor
•each tablet contains: sodium 21 mg
•store at 20-25°C (68-77°F). Avoid high humidity and excessive heat above 40°C (104°F).
FD&C blue no. 2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, titanium dioxide
Naproxen Sodium 220 MG
Each tablet contains naproxen sodium....220 mg
Dosage: See prescribing information.
Store at 68 to 77 degrees F
Store in a tight, light-resistant container. Protect from moisture.
Keep out of the reach of children.
Distributed by: Perrigo, Allergan, MI 49010
Repackaged by Northwind Pharmaceuticals, Indianapolis, IN 46256
* Please review the disclaimer below.