Active ingredient (in each capsule)
Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)*
*nonsteroidal anti-inflammatory drug
Purpose
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
- •
- 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:
- •
- 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
- •
- stomach pain or upset gets worse or lasts
- •
- redness or swelling is present in the painful area
- •
- any new symptoms appear
- •
- you have difficulty swallowing
- •
- it feels like the capsule is stuck in your throat
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)
Directions
- •
- do not take more than directed
- •
- the smallest effective dose should be used
- •
- drink a full glass of water with each dose
- •
- if taken with food, this product may take longer to work
adults and
children 12 years
and older:
|
- •
- take 1 capsule every 8 to 12 hours while symptoms last
- •
- for the first dose you may take 2 capsules within the first hour
- •
- do not exceed 2 capsules in any 8- to 12- hour period
- •
- do not exceed 3 capsules in a 24 hour period
|
children
under 12
years:
|
- •
- ask a doctor
|
Other information
- •
- each capsule contains: sodium 20 mg
- •
- store at 20-25°C (68-77°F) avoid high humidity and excessive heat above 40°C (104°F).
- •
- do not use if printed foil under cap is broken or missing
- •
- read all directions and warnings before use.
Inactive ingredients
FD&C Blue #1, gelatin, glycerin, lactic acid, mannitol, pharmaceutical ink, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol
Questions or comments?
1-800-809-0469
Package/Label Principal Display Panel
naproxen sodium
capsules, 220 mg (NSAID)
pain reliever/fever reducer
see new warnings information
(**liquid filled capsules)
Naproxen Sodium Label