ACTIVE INGREDIENT(S)
(in each tablet)
Naproxen sodium 220mg
(naproxen 200mg) (NSAID)*
*nonsteroidal anti-inflammatory drug
USE(S)
■ temporarily relieves minor aches and pains due to:
■ minor pain of arthritis ■ muscular aches
■ backache ■ menstrual cramps
■ headache ■ toothache
■ the common cold
■ 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
■ 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
■ under a doctor's care for any serious condition
■ taking any other drug
STOP USE AND ASK 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
■ you have symptoms of heart problems or stroke:
■ chest pain ■ trouble breathing
■ weakness in one part or side of body
■ slurred speech ■ leg swelling
■ 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 of swelling is present in the painful area
■ any new symptoms appear
You may report side effects to FDA at 1-800-FDA-1088
PREGNANCY/BREASTFEEDING
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 over | ■ 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-hr period |
| Children under 12 years | ■ ask a doctor |
OTHER INFORMATION
■ each tablet contains: sodium 20mg
■ store at 20 to 250C (68 to 770F). Avoid high
humidity and excessive heat above 400C (1040F).
INACTIVE INGREDIENTS
FD&C blue #2 lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, sodium starch glycolate, starch, talc, titanium dioxide
