Naproxen Sodium description, usages, side effects, indications, overdosage, supplying and lots more!

Menu
Search

Naproxen Sodium

MARKSANS PHARMA LIMITED

NAPROXEN SODIUM- naproxen sodium tablet, coatedMarksans Pharma Limited


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient(s)




 

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:
  • 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:

  • 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)

Naproxen Sodium 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



Naproxen Sodium


Naproxen Sodium

Naproxen Sodium

Naproxen Sodium Tablet, coated TABLET

Product Information

Product Type Human otc drug label 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 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 Size Imprint Code Shape
BLUE 12 mm 144 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:25000-144-14 1000 in 1 BOTTLE, PLASTIC
2 6500 in 1 BAG
3 6500 in 1 BAG
4 24 in 1 BOTTLE
5 1 in 1 CARTON
6 NDC:25000-144-02 160 in 1 BOX

Marketing Information

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


Naproxen Sodium

Naproxen Sodium, Coated Tablets TABLET

Product Information

Product Type Human otc drug label 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 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 Size Imprint Code Shape
BLUE 10 mm 141 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:25000-141-14 1000 in 1 BOTTLE, PLASTIC
2 1600 in 1 BAG
3 6500 in 1 BAG
4 24 in 1 BOTTLE
5 1 in 1 CARTON
6 NDC:25000-141-02 160 in 1 BOX

Marketing Information

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


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
Copyright © 2014. drugs-library.com. All rights reserved. Information on drugs-library.com is provided for educational purposes only and is not to be used for medical advice, diagnosis or treatment.
Support info@drugs-library.com.