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  5. Label Information: Naproxen

FDA Label for Naproxen

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT (IN EACH TABLET)
    3. PURPOSES
    4. USES
    5. ALLERGY ALERT
    6. STOMACH BLEEDING WARNING
    7. DO NOT USE
    8. ASK A DOCTOR BEFORE USE IF
    9. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    10. WHEN USING THIS PRODUCT
    11. STOP USE AND ASK A DOCTOR IF
    12. OTC - PREGNANCY OR BREAST FEEDING
    13. OTC - KEEP OUT OF REACH OF CHILDREN
    14. DIRECTIONS
    15. OTHER INFORMATION
    16. INACTIVE INGREDIENTS
    17. QUESTIONS OR COMMENTS?
    18. PRINCIPAL DISPLAY PANEL – 100 TABLET BOTTLE CARTON

Naproxen Product Label

The following document was submitted to the FDA by the labeler of this product Medline Industries, Inc.. 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.

Other



Drug Facts

Dist. by:
Medline Industries, Inc.

Mundelein, IL 60060


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

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

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



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



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
    • 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 periodask a doctor

    Adults and children 12 years and older

    ••••

    Children under 12 years

    •

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


Questions Or Comments?



Call toll free 1-800-MEDLINE (633-5463) Monday-Friday 9am-5pm cst)


Principal Display Panel – 100 Tablet Bottle Carton



Medline

NDC53329-675-30

**Compare to the active ingredient in Aleve

Naproxen

Pain Reliever/

Fever Reducer (NSAID)

Strength to last 12 Hours

Naproxen Sodium Tablets

220 mg

100 Tablets – 220 mg each

PRINCIPAL DISPLAY PANEL - 24 Tablet Bottle Carton - aleve 01

PRINCIPAL DISPLAY PANEL - 24 Tablet Bottle Carton - aleve 01


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