Naproxen Sodium (naproxen sodium 220 mg) Dailymed
Generic: naproxen sodium is used for the treatment of Arthritis, Juvenile Arthritis, Rheumatoid Back Pain Bursitis Common Cold Dysmenorrhea Fever Gout Headache Inflammation Osteoarthritis Pain Pregnancy Trimester, Third Spondylitis, Ankylosing Toothache
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Active Ingredient(s)
 Naproxen Sodium 220 mg (naproxen 200 mg) (NSAID)*
 *nonsteroidal anti-inflammatory drug
Purpose
Pain reliever/Fever reducerÂ
Use(s)
temporarily relieves minor aches and pains due to:
- minor pain of arthritis
- muscular aches
- backache
- menstrual cramps
- headache
- 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:
- 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 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
- Â if you have ever had an allergic reaction to any other pain reliever/fever reducer
- Â right before or after heart surgery
Ask A Doctor Before Use If
- Â the stomach bleeding warning applies to you
- Â 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
- Â 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
- redness or swelling is present in the painful area
- any new symptoms appear
- you have difficulty swallowing
- it feels like the pill is stuck in your throat
Pregnancy/breastfeeding
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 (1-800-222-1222).
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 3Â tablets in a 24-hour period
children under 12 years:
- ask a doctor
Storage
store at 20-25°C (68-77°F) avoid high humidity and excessive heat above 40°C (104°F).
Other Information
- each tablet contains: sodium 20 mg
- side effects occur. You may report side effects to PolyGen at 1-888-291-7337 and/ or FDA at 1-800-FDA-1088.
Inactive Ingredients
colloidal silicon dioxide, croscarmellose sodium, FD&C blue #2 lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycols, povidone, titanium dioxide.
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Questions Or Comments
1-800-291-7337
Principal Display Panel
NAPROXEN SODIUM TABLETS: Â
Carton PDP:
NDC: 52605-141-01
Compare to the active ingredient in Aleve®
ALL DAY PAIN RELIEF
NAPROXEN SODIUM TABLETS, USP 220 mg
PAIN RELIEVER/ FEVER REDUCER (NSAID)
Â
STRENGTH TO LAST 12 HOURS
100 TABLETS
Bottle Label PDP:
NDC: 52605-141-01
ALL DAY PAIN RELIEF
NAPROXEN SODIUM TABLETS, USP 220 mg
PAIN RELIEVER/ FEVER REDUCER (NSAID)
Â
STRENGTH TO LAST 12 HOURS
100 TABLETS
NAPROXEN SODIUM CAPLETS:  Carton PDP:  NDC: 52605-144-01 Compare to the active ingredient in Aleve®  ALL DAY PAIN RELIEF NAPROXEN SODIUM TABLETS, USP 220 mg PAIN RELIEVER/ FEVER REDUCER (NSAID)  STRENGTH TO LAST 12 HOURS  100 CAPLETS (CAPSULE- SHAPED TABLETS)  Bottle Label PDP:  NDC: 52605-144-01  ALL DAY PAIN RELIEF NAPROXEN SODIUM TABLETS, USP 220 mg PAIN RELIEVER/ FEVER REDUCER (NSAID)  STRENGTH TO LAST 12 HOURS  100 CAPLETS (CAPSULE- SHAPED TABLETS)  NAPROXEN SODIUM CAPLETS:  Carton PDP:  NDC: 52605-144-24 Compare to the active ingredient in Aleve®  ALL DAY PAIN RELIEF NAPROXEN SODIUM TABLETS, USP 220 mg PAIN RELIEVER/ FEVER REDUCER (NSAID)  STRENGTH TO LAST 12 HOURS  24 CAPLETS (CAPSULE- SHAPED TABLETS)  Bottle Label PDP:  NDC: 52605-144-24  ALL DAY PAIN RELIEF NAPROXEN SODIUM TABLETS, USP 220 mg PAIN RELIEVER/ FEVER REDUCER (NSAID)  STRENGTH TO LAST 12 HOURS  24 CAPLETS (CAPSULE- SHAPED TABLETS)
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