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  5. Label Information: Naproxen Sodium

FDA Label for Naproxen Sodium

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT(S)
    2. PURPOSE
    3. USE(S)
    4. WARNINGS
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF
    7. ASK A DOCTOR OR PHARMACIST BEFORE USE IF
    8. WHEN USING THIS PRODUCT
    9. STOP USE AND ASK DOCTOR IF
    10. PREGNANCY/BREASTFEEDING
    11. KEEP OUT OF REACH OF CHILDREN
    12. DIRECTIONS
    13. OTHER INFORMATION
    14. INACTIVE INGREDIENTS
    15. QUESTIONS OR COMMENTS

Naproxen Sodium Product Label

The following document was submitted to the FDA by the labeler of this product A-s Medication Solutions. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient(S)



(in each tablet)
Naproxen sodium 220mg
(naproxen 200mg) (NSAID)*
*nonsteroidal anti-inflammatory drug


Purpose



Pain reliever/Fever reducer


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                              ■ 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:
■ 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.

Heart attack and stroke warning: NSAIDs, except aspirin,
increase 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.


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, 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


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


Stop Use And Ask 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 of swelling is present in the painful area
■ any new symptoms appear
You may report side effects to FDA at 1-800-FDA-1088


Pregnancy/Breastfeeding



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



■ 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 over
■ 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-hr period
Children under 12 years
■ ask a doctor



Other Information




■ each tablet contains: sodium 20mg
■ store at 20 to 250C (68 to 770F). Avoid high
humidity and excessive heat above 400C (1040F).



Inactive Ingredients



FD&C blue #2 lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, sodium starch glycolate, starch, talc, titanium dioxide


Questions Or Comments



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Distributed By: Camber Consumer Care, Inc.
Piscataway, NJ 08854, USA




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