Naproxen Sodium 220mg Tablet
FDA Label NDC 53329-688

Active ingredient (in each tablet)

Naproxen sodium, USP 220 mg

(naproxen 200 mg) (NSAID)

*nonsteroidal anti-inflammatory drug

Purposes

Pain reliever/ fever reducer

Uses ■ temporarily relieves minor aches and pains due to:
■ headache ■ muscular aches ■ minor pain of arthritis ■ toothache
■ backache ■ the common cold ■ menstrual cramps
■ temporarily reduces fever

Warnings
Allergy alert: 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 ■ blisters
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 ■ have 3 or more alcoholic
drinks every day while using this product take other drugs containing prescription or nonprescription NSAIDs

(aspirin, ibuprofen, naproxen, or others)
■ 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 ■ 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

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.

Directions ■ 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

Other information ■ each tablet contains: sodium 20 mg ■ store at
20° to 25°C (68° to 77°F). Avoid high humidity and excessive heat above
40°C (104°F).

Inactive Ingredients colloidal silicon dioxide, croscarmellose sodium,
FD&C blue # 2 lake, hypromellose, magnesium stearate, microcrystalline
cellulose, polyethylene glycol, povidone, titanium dioxide

Stop 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