Naproxen Sodium Tablet
FDA Label NDC 25000-141

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Marksans Pharma Limited for the product Naproxen Sodium (NDC 25000-141). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient(s), purpose, use(s), warnings, do not use, ask a doctor before use if, ask a doctor or pharmacist before use if, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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
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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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