ALL DAY PAIN RELIEF (naproxen sodium 220 mg) Dailymed

Drug Facts

Otc - Active Ingredient Section

Naproxen Sodium 220 mg

(naproxen 200 mg)(NSAID)* *nonsteroidal anti-inflammatory drug

Otc - Purpose Section

Pain reliever/Fever reducer

Indications & Usage Section

• temporarily relieves minor aches and pains due to:

o minor pain of arthritis o muscular aches o backache o menstrual cramps o headache o toothache o the common cold

• temporarily reduces fever

Warnings Section

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 bulers

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 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.

Heart attack and stroke warning: NSAID's, except aspirin, increases 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.

Otc - Do Not Use Section

Do not use

• if you have ever had an allergic reaction to any other pain reliever/fever reducer
• right before or after heart surgery

Otc - Ask Doctor Section

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

Otc - Ask Doctor/pharmacist Section

Ask a doctor or pharmacist before use if you are

• under a doctor's care for any serious condition
• taking aspirin for heart attack or stroke, because naproxen may decrease this benefit of aspirin
• taking any other drug

Otc - When Using Section

When using this product

take with food or milk if stomach upset occurs

Otc - Stop Use Section

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

you have symptoms of heart problems or stroke:

chest pain

trouble breathing

weakness in one part or side of body

slurred speech

leg swelling

• 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 at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Otc - Keep Out Of Reach Of Children Section

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).

Dosage & Administration Section

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 cablet every 8 to12 hours while symptoms last for the first dose, you may take 2 caplets within the first hour do not exceed 2 caplets in any 8-to 12-hour period do not exceed 3 caplets in a 24-hour period

Children under 12 years:

ask a doctor

Other information

each caplet contains: sodium 20 mg store at 20-25ºC (68-77ºF).

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