Active Ingredients

Naproxen Sodium 220mg (Naproxen 200mg)(NSAID)* ........... Pain reliever/fever reducer

*nonsteriodal anti-inflammatory drug

Uses

Temporarily relieves minor aches and pains due to:

- Headaches

- Toothaches

- Muscular aches

- Menstrual cramps

- The common cold

- Backache

- Minor pain of arthritis

- Reduces fever

Warnings

Allergy alert: Naproxen sodium may cause a severe allergic reaction which 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 a nonsteriodial anti-inflammatory drug (NSAID), which may cause 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 steriod drug

- Take other drugs containing an NSAID (aspirin, ibuprofen, naproxen, or others)

- Have had 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 ever had an allergic reaction to any other pain reliever/fever reducer. Do not use right before or after heart surgery.

Ask a doctor before use if you have:

- Stomach pains

- Problems or serious side effects from taking pain relievers or fever reducers

- Ulcers

- Bleeding problems

- High blood pressure

- Heart or kidney disease

- Taken a diuretic

- Reached age 60 or older

Ask a doctor or pharmacist before use if you are:

- Under a doctor’s care for any serious condition

- Taking any other drug containing NSAID (prescription or non-prescription)

- Taking a blood thinning (anticoagulant) or steriod drug

- Under a doctor’s care for any serious condition

- Taking any other drug

When using this product give with food or milk if stomach upset occurs.

Long term continious use may increase the risk of heart attack or stroke.

Stop use and ask a doctor if:

- You feel faint, vomit blood, or have bloody or black stools. These are signs of stomach bleeding.

- 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

If pregnant or breast feeding, ask a health professional before use. It is especially important not to use ibuprofen 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.

Overdose Warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

Do not take more than directed. (See overdose warning.)

Adults and children 12 years and older take 1 TABLET every 8 to 12 HOURS while symptoms persist. 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 should consult with a doctor.

Other Information

Each tablet contains: sodium 20 mg.

- Store between 68° to 77°F (20° to 25°C)

- Avoid high humidity and excessive heat above 104°F (40°C)

Inactive Ingredients

FD&C Blue #2 Lake, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Povidone, Talc, Titanium Dioxide.

Questions?

For more information on this product please call 1-800-395-0689 (Mon - Fri 9AM - 5PM EST) or visit www.aleve.com.