Naproxen
SPL UNCLASSIFIED SECTION
Drug Facts
Active ingredient (in each tablet)
Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)nonsteroidal anti-inflammatory drug
Purposes
Pain reliever/fever reducer
Uses
- •temporarily relieves minor aches and pains due to:•headache•minor pain of arthritis•backache•menstrual cramps•muscular aches•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:
If an allergic reaction occurs, stop use and seek medical help right away.
- •hives
- •facial swelling
- •asthma (wheezing)
- •shock
- •skin reddening
- •rash
- •blisters
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 have problems or serious side effects from taking pain relievers or fever reducers
- •you have asthma
- •you are taking a diuretic
Ask a doctor or pharmacist before use if you are
- •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 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
- •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.
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.
Directions
| 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 |
- •do not take more than directed
- •the smallest effective dose should be used
- •drink a full glass of water with each dose
Other information
- •each tablet contains: sodium 20 mg
- •store at room temperature. Avoid excessive heat above 40°C (104°F).
- •read all warnings and directions before use. Keep carton
Inactive ingredients
FD&C blue #2 aluminum lake, hypromellose 2910, maize starch, microcrystalline cellulose, polyethylene glycol, povidone k-30, sodium starch glycolate, stearic acid, titanium dioxide
SPL UNCLASSIFIED SECTION
Dist. by:Medline Industries, Inc.
Mundelein, IL 60060