Active ingredient(s)
Naproxen Sodium Tablets, USP
220 mg (NSAID)*
*nonsteroidal anti-inflammatory drug
Purpose
Pain reliever/ fever reducer
Use(s)
temporarily relieves minor aches and pain due to:
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- backache
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- headache
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- menstrual cramps
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- minor pain of arthritis
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- muscular aches
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- the common cold
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- toothache
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- temporarily reduces fever
Warnings
Allergy alerts: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
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- asthma (wheezing)
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- blisters
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- facial swelling
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- hives
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- rash
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- shock
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- skin reddening
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 bad stomach ulcers or bleeding problems
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- take a blood thinning (anticoagulant) or steroid drug
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- take other drug 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 sluck in your throat
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- redness or swelling is present in the painful area
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- any new symptoms appear
Pregnancy/Breastfeeding
ask a health professional before use. It is especially important not to use naproxen sodium during the last 3 months of the 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 accidental overdose, get medical help or contact a poison control center right away.
Directions
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- do not more than directed
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- the smallest effective dose should be used
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- do not take longer than 10 days, unless directred by a doctor (see Warnings)
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- drink a full glass of water with each dose
Adults and children 12 years and older:
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- take 1 tablet every 8 to12 hours while symptoms last
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- for first dose you may take 2 tablets within the first hour
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- do not exceed 2 tablets in any 8 to 12 hour period
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- do not exceed 3 tablets in a 24 hours period
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children under 12 years:
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- ask a doctor
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Storage
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- Store at 20-25oC (68-77oF). Avoid high humidity and excessive heat above 400C (1040F)
Other information
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-
each tablet contain: sodium 20 mg
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- Questions or comments? 1-800-645-2158
Inactive ingredients
Colloidal silicon dioxide, croscarmellose sodium, FD&C blue #2 lake, Hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, titanium dioxide.
Distributed by
Rugby Laboratories
Livonia, MI 48150 USA
Repackaged By: Preferred Pharmaceuticals Inc.
Principal Display Panel
Container label caplets (capsule shaped tablets)
Preferred Pharmaceuticals Inc.