Active ingredient (in each tablet)
Naproxen sodium 220 mg
(Naproxen 200 mg) (NSAID)*
*nonsteroidal anti-inflammatory drug
Uses
temporarily relieves minor aches and pain due to:
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- backache
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- muscular aches
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- minor pain of arthritis
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- menstrual cramps
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- headache
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- toothache
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- 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:
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- hives
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- facial swelling
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- asthma (wheezing)
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- shock
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- skin reddening
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- rash
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- blisters
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:
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- are age 60 or older
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- have had stomach ulcers or bleeding problems
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- take a blood thinning (anticoagulant) or steroid drug
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- take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
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- have 3 or more alcoholic drinks every day while using this product.
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- take more or for a longer time than directed.
Do not use
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- if you have ever had an allergic reaction to any other pain reliever / fever reducer
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- right before or after heart surgery
Ask a doctor before use if
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- the stomach bleeding warning applies to you
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- you have a history of stomach problems such as heartburn
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- you have high blood pressure, heart disease, liver cirrhosis or kidney disease
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- you are taking a diuretic
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- you have problems or serious side effects from taking pain relievers or fever reducers
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- you have asthma
Ask a doctor or pharmacist before use if
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- under a doctor's care for any serious condition
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- taking any other drug
When using this product
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- take with food or milk if stomach upset occurs
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- 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
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- you experience any of the following signs of stomach bleeding:
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- feel faint
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- vomit blood
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- have bloody or black stools
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- have a stomach pain that dose not get better
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- pain gets worse or lasts more than 10 days
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- fever gets worse or lasts more than 3 days
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- you have difficulty swallowing
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- it feels like the pill is stuck in your throat
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- redness or swelling is present in the painful area
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- any new symptoms appear
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
In case of overdose, get medical help or contact a poison control center right away.
Directions
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- do not take more than directed
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- the smallest effective dose should be used
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- drink a full glass of water with each dose
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Adults and children 12 years and older: |
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Children under 12 years: |
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Other information
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- each tablet contains: sodium 20 mg
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- If side effects occur, you may report side effects to
FDA at 1-800-FDA-1088
