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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. STORAGE
    14. OTHER INFORMATION
    15. INACTIVE INGREDIENTS
    16. MANUFACTURED FOR
    17. MANUFACTURED BY
    18. PRINCIPAL DISPLAY PANEL

Naproxen Sodium Product Label

The following document was submitted to the FDA by the labeler of this product Marksans Pharma Limited. 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)




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:

  • backache
  • muscular aches
  • minor pain of arthritis
  • 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 bad 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: NSAID's, except aspirin, increases 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 a stomach pain that dose 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 or swelling is present in the painful area
      • any new symptoms appear


Pregnancy/Breastfeeding




ask 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 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 older:
     
    • take 1 tablet every 8 to12 hours while symptoms last
    • for first dose you may take 2 tablets with in the first hour
    • do not exceed 2 tablets in any 8-to 12-hour period
    • do not exceed 3 tablets in a 24-hour period
      •  
    Children under 12 years:
    • ask a doctor

Storage



 

  • Store at 20-25oC (68-77oF). Avoid high humidity and excessive heat above 400C (1040F)

Other Information



  • each tablet contains: sodium 20 mg

    • Questions or comments?
    call toll free 1-877-376-4271



Inactive Ingredients




Colloidal silicon dioxide, croscarmellose sodium, FD&C blue #2 lake, Hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone,  titanium dioxide.

 


Manufactured For



Time-Cap Labs, Inc.

7 Michael Avenue,

Farmingdale,

NY 11735, USA


Manufactured By





Marksans Pharma Ltd.

Plot No.L-82, L-83, Verna Indl. Estate

Verna, Goa – 403 722, India


Mfg. Lic. No. GO/ Drugs/515


Principal Display Panel



10s-Tablets-bottle-Label
NDC25000-141-43



10s-Tablets-bottle-Carton-Label
NDC25000-141-43



24s-Tablets-bottle-Label
NDC25000-141-02



24s-Tablets-bottle-carton-Label
NDC25000-141-02



1000s-Tablets-bottle-Label
NDC25000-141-14



10s-oval-shaped-tablet-bottle-Label
NDC25000-144-43




24s-oval-shaped-tablet-bottle-Label
NDC25000-144-02




10s-oval-shaped-tablet-bottle-carton-Label
NDC25000-144-43



24s-oval-shaped-tablet-bottle-carton-Label
NDC25000-144-02




1000s-oval-shaped-tablet-bottle-Label
NDC25000-144-14




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