Naproxen Sodium Tablets USP 220mg (Round)
Active ingredient
(in each tablet)
Naproxen sodium 220 mg (NSAID)**
**nonsteroidal anti-inflammatory drug
Purposes
Pain reliever/fever reducer
Uses
■ minor pain of arthritis
■ muscular aches
■ backache
■ menstrual cramps
■ headache
■ toothache
■ the common cold
- temporarily relieves minor aches and pains due to:
Warnings
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.
- hives
- facial swelling
- asthma (wheezing)
- shock
- skin reddening
- rash
- blisters
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
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 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, kidney disease, asthma, or had a stroke
- you are taking a diuretic
- you 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 condition
- taking any other drug
When using this product
- take with food or milk if stomach upset occurs
Stop use and ask a doctor if
■ feel faint ■ vomit blood ■ have bloody or black stools ■ have stomach pain that does not get better
■ chest pain ■ trouble breathing ■ weakness in one part or side of body ■ slurred speech
■ leg swelling
- you experience any of the following signs of stomach bleeding
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 the reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away
Directions
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
- do not take more than directed
- the smallest effective dose should be used
- drink a full glass of water with each dose
Other information
- each tablet contains: sodium 20 mg
- store at 20 - 25°C (68 to 77°F). Avoid high humidity and excessive heat above 40°C (104°F)
Inactive ingredients
FD&C blue #2 aluminum lake, hypromellose 2910, maize starch, microcrystalline cellulose, polyethylene glycol, povidone k-30, sodium starch glycolate, stearic acid, titanium dioxide.