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Name:Naproxen Sodium
Manufacturer:Marksans Pharma Limited
Category:Over-the-counter (OTC) Marketed Drugs


NAPROXEN SODIUM- naproxen sodium tablet, coatedMarksans Pharma Limited

NAPROXEN SODIUM  - naproxen sodium tablet 
Marksans Pharma Limited

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NAPROXEN SODIUM- naproxen sodium tablet, coated
Marksans Pharma Limited

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
  • headache
  • menstrual cramps
  • minor pain of arthritis
  • muscular aches
  • the common cold
  • toothache
  • temporarily reduces fever

Warnings


Allergy alerts: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
  • asthma (wheezing)
  • blisters
  • facial swelling
  • hives
  • rash
  • shock
  • 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:
 
  • are age 60 or older
  • have bad stomach ulcers or bleeding problems
  • take a blood thinning (anticoagulant) or steroid drug
  • take other drug 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 are taking a diuretic
  • you have problems or serious side effects from taking pain relievers or fever reducers
  • you have asthma

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
  • 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


 

 

  • 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
  • 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 sluck 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 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 hours
  • do not exceed 2 tablets in any 8 to 12 hour period
  • do not exceed 3 tablets in a 24 hours 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 contain: sodium 20 mg
  • Side effects occur. You may report side effects to FDA at 1-800-FDA-1088.

Inactive ingredients


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

 

Manufactured for


Marksans Pharma Inc.

Lake Grove, NY11755, USA

Manufactured by


Marksans Pharma Ltd.

Verna, Goa-403722, India

 

Mfg. Lic. No. GO/ Drugs/515

Principal Display Panel


Container label (oval shaped)
container label (oval shaped)

Container label (round shaped)
 
Container label (round shaped)

NAPROXEN SODIUM 
naproxen sodium tablet, coated tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:25000-144
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NAPROXEN SODIUM (NAPROXEN) NAPROXEN SODIUM 220 mg
Inactive Ingredients
Ingredient Name Strength
COLLOIDAL SILICON DIOXIDE  
CROSCARMELLOSE SODIUM  
FD&C BLUE NO. 2  
HYPROMELLOSES  
MAGNESIUM STEARATE  
CELLULOSE, MICROCRYSTALLINE  
POLYETHYLENE GLYCOL  
POVIDONE  
TITANIUM DIOXIDE  
Product Characteristics
Color BLUE Score no score
Shape OVAL Size 12mm
Flavor Imprint Code 144
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:25000-144-14 1000 TABLET (1000 TABLET) in 1 BOTTLE, PLASTIC None
2 NDC:25000-144-20 4 BAG (4 BAG) in 1 BOX contains a BAG
2 6500 TABLET (6500 TABLET) in 1 BAG This package is contained within the BOX (25000-144-20)
3 NDC:25000-144-30 6 BAG (6 BAG) in 1 BOX contains a BAG
3 6500 TABLET (6500 TABLET) in 1 BAG This package is contained within the BOX (25000-144-30)
4 NDC:25000-144-02 160 CARTON (160 CARTON) in 1 BOX contains a CARTON
4 1 BOTTLE (1 BOTTLE) in 1 CARTON This package is contained within the BOX (25000-144-02) and contains a BOTTLE
4 24 TABLET (24 TABLET) in 1 BOTTLE This package is contained within a CARTON and a BOX (25000-144-02)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090545 05/04/2011

NAPROXEN SODIUM 
naproxen sodium, coated tablets tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:25000-141
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NAPROXEN SODIUM (NAPROXEN) NAPROXEN SODIUM 220 mg
Inactive Ingredients
Ingredient Name Strength
COLLOIDAL SILICON DIOXIDE  
CROSCARMELLOSE SODIUM  
FD&C BLUE NO. 2  
CELLULOSE, MICROCRYSTALLINE  
POLYETHYLENE GLYCOL  
POVIDONE  
TITANIUM DIOXIDE  
HYPROMELLOSES  
MAGNESIUM STEARATE  
Product Characteristics
Color BLUE Score no score
Shape ROUND Size 10mm
Flavor Imprint Code 141
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:25000-141-14 1000 TABLET (1000 TABLET) in 1 BOTTLE, PLASTIC None
2 NDC:25000-141-26 2 BAG (2 BAG) in 1 BOX contains a BAG
2 1600 TABLET (1600 TABLET) in 1 BAG This package is contained within the BOX (25000-141-26)
3 NDC:25000-141-30 6 BAG (6 BAG) in 1 BOX contains a BAG
3 6500 TABLET (6500 TABLET) in 1 BAG This package is contained within the BOX (25000-141-30)
4 NDC:25000-141-02 160 CARTON (160 CARTON) in 1 BOX contains a CARTON
4 1 BOTTLE (1 BOTTLE) in 1 CARTON This package is contained within the BOX (25000-141-02) and contains a BOTTLE
4 24 TABLET (24 TABLET) in 1 BOTTLE This package is contained within a CARTON and a BOX (25000-141-02)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090545 05/28/2011

Labeler - Marksans Pharma Limited (925822975)
Establishment
Name Address ID/FEI Operations
Marksans Pharma Limited 925822975 MANUFACTURE

Revised: 06/2011 Marksans Pharma Limited



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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