gc 951
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:
temporarily reduces fever
- •backache
- •muscular aches
- •minor pain of arthritis
- •menstrual cramps
- •headache
- •toothache
- •the common cold
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.
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:
- •hives
- •facial swelling
- •asthma (wheezing)
- •shock
- •skin reddening
- •rash
- •blisters
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
OTC - PREGNANCY OR BREAST FEEDING SECTION
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
| 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: | •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
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.