Active ingredient (in each tablet)
Naproxen sodium 220 mg
(Naproxen 200 mg) (NSAID)*
*nonsteroidal anti-inflammatory drug
Purpose
Pain reliever/ fever reducer
Uses
temporarily relieves minor aches and pain due to:
- backache
- muscular aches
- minor pain of arthritis
- 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.
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
- 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 doctor if
- you experience any of the following signs of stomach bleeding:
- feel faint
- vomit blood
- have bloody or black stools
- have a stomach pain that dose 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.
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 to12 hours while symptoms last
- for first dose you may take 2 tablets with in 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:
|
|
Storage
- Store at 20-25
oC (68-77
oF). Avoid high humidity and excessive heat above 40
0C (104
0F)
Other information
-
each tablet contains: sodium 20 mg
- If side effects occur, you may report side effects to
FDA at 1-800-FDA-1088
Inactive ingredients
Colloidal silicon dioxide, croscarmellose sodium, FD&C blue #2 lake, Hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, titanium dioxide.
Questions or comments?
Call 1-800-540-3765
HOW SUPPLIED
Product: 71335-0274
NDC: 71335-0274-2 20 TABLET in a BOTTLE
NDC: 71335-0274-3 30 TABLET in a BOTTLE
NDC: 71335-0274-4 40 TABLET in a BOTTLE
NDC: 71335-0274-5 50 TABLET in a BOTTLE
NDC: 71335-0274-6 60 TABLET in a BOTTLE
NDC: 71335-0274-7 14 TABLET in a BOTTLE
NDC: 71335-0274-8 100 TABLET in a BOTTLE
NDC: 71335-0274-9 90 TABLET in a BOTTLE
Naproxen Sodium 220mg Tablet