gc 951-954L
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:
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.
- •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, 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
When using this product
- •take with food or milk if stomach upset occurs
Stop use and ask doctor if
leg swelling chest pain slurred speech trouble breathing weakness in one part or side of body
- •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
- •you have symptoms of heart problems or stroke
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
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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
Storage
- •Store at 20-25 oC (68-77 oF). Avoid high humidity and excessive heat above 40 0C (104 0F)
Other information
Repackaged by Preferred Pharmaceuticals, Inc.
- •each tablet contains: sodium 20 mg
- NDC 68788-7582-02 Bottle of 20 NDC 68788-7582-03 Bottle of 30 NDC 68788-7582-04 Bottle of 40 NDC 68788-7582-06 Bottle of 60
Inactive ingredients
croscarmellose sodium, FD&C blue #2 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, talc, titanium dioxide