NAPROXEN SODIUM - naproxen sodium tablet, coated 
Polygen Pharmaceuticals LLC

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Naproxen Sodium Tablets, USP 220 mg

Active ingredient(s)


 Naproxen Sodium 220 mg (naproxen 200 mg) (NSAID)*

 *nonsteroidal anti-inflammatory drug

Purpose


Pain reliever/Fever reducer 


Use(s)


temporarily relieves minor aches and pains due to:

Warnings


Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:


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:

Do not use

Ask a doctor before use if


Ask a doctor or pharmacist before use if

When using this product

Stop use and ask doctor if


Pregnancy/Breastfeeding


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.

Keep out of reach of children



In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions


adults and children 12 years and older:
  • 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 period
children under 12 years:
  • ask a doctor

Storage


store at 20-25°C (68-77°F) avoid high humidity and excessive heat above 40°C (104°F).

Other information

Inactive ingredients


colloidal silicon dioxide, croscarmellose sodium, FD&C blue #2 lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycols, povidone, titanium dioxide.

 

Questions or comments


1-800-291-7337


Principal Display Panel



NAPROXEN SODIUM TABLETS:
 

Carton PDP:

NDC: 52605-141-01

Compare to the active ingredient in Aleve®

ALL DAY PAIN RELIEF

NAPROXEN SODIUM TABLETS, USP 220 mg

PAIN RELIEVER/ FEVER REDUCER (NSAID)

 

STRENGTH TO LAST 12 HOURS

100 TABLETS



Naproxensodium

Bottle Label PDP:

NDC: 52605-141-01

ALL DAY PAIN RELIEF

NAPROXEN SODIUM TABLETS, USP 220 mg

PAIN RELIEVER/ FEVER REDUCER(NSAID)

 

STRENGTH TO LAST 12 HOURS

100 TABLETS



Naproxensodiumtablets

NAPROXEN SODIUM CAPLETS:
 

Carton PDP:
 
NDC: 52605-144-01
 
Compare to the active ingredient in Aleve®
 
ALL DAY PAIN RELIEF
NAPROXEN SODIUM TABLETS, USP 220 mg
PAIN RELIEVER/ FEVER REDUCER (NSAID)
 
STRENGTH TO LAST 12 HOURS
 
100 CAPLETS (CAPSULE- SHAPED TABLETS)
 
Naproxensodium
 

Bottle Label PDP:
 
NDC: 52605-144-01
 
 
ALL DAY PAIN RELIEF
NAPROXEN SODIUM TABLETS, USP 220 mg
PAIN RELIEVER/ FEVER REDUCER (NSAID)
 
STRENGTH TO LAST 12 HOURS
 
100 CAPLETS (CAPSULE- SHAPED TABLETS)
 
Naproxensodiumcaplets 




NAPROXEN SODIUM CAPLETS:
 

Carton PDP:
 
NDC: 52605-144-24
 
Compare to the active ingredient in Aleve®
 
ALL DAY PAIN RELIEF
NAPROXEN SODIUM TABLETS, USP 220 mg
PAIN RELIEVER/ FEVER REDUCER (NSAID)
 
STRENGTH TO LAST 12 HOURS
 
24 CAPLETS (CAPSULE- SHAPED TABLETS)



 naproxensodium24


Bottle Label PDP:
 
NDC: 52605-144-24
 
 
ALL DAY PAIN RELIEF
NAPROXEN SODIUM TABLETS, USP 220 mg
PAIN RELIEVER/ FEVER REDUCER (NSAID)
 
STRENGTH TO LAST 12 HOURS
 
24 CAPLETS (CAPSULE- SHAPED TABLETS)



naproxensodium24




NAPROXEN SODIUM 
naproxen sodium tablet, coated
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:52605-141
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NAPROXEN SODIUM (NAPROXEN) NAPROXEN SODIUM220 mg
Inactive Ingredients
Ingredient NameStrength
COLLOIDAL SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
FD&C BLUE NO. 2 
HYPROMELLOSES 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POVIDONE 
TITANIUM DIOXIDE 
POLYETHYLENE GLYCOLS 
Product Characteristics
ColorBLUEScoreno score
ShapeROUNDSize10mm
FlavorImprint Code 141
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52605-141-011 in 1 CARTON
1100 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09054506/11/2012
NAPROXEN SODIUM 
naproxen sodium tablet, coated
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:52605-144
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NAPROXEN SODIUM (NAPROXEN) NAPROXEN SODIUM220 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
COLLOIDAL SILICON DIOXIDE 
FD&C BLUE NO. 2 
HYPROMELLOSES 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POVIDONE 
TITANIUM DIOXIDE 
POLYETHYLENE GLYCOLS 
Product Characteristics
ColorBLUEScoreno score
ShapeOVALSize12mm
FlavorImprint Code 144
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52605-144-011 in 1 CARTON
1100 in 1 BOTTLE
2NDC:52605-144-241 in 1 CARTON
224 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09054511/13/2012
Labeler - Polygen Pharmaceuticals LLC (962415720)
Registrant - Polygen Pharmaceuticals LLC (962415720)
Establishment
NameAddressID/FEIBusiness Operations
Marksans Pharma Limited925822975MANUFACTURE(52605-144)

Revised: 6/2013
Document Id: b06d4755-1fbf-4fcf-9075-cb1691292aad
Set id: e8720904-9ac0-46c0-b220-730e373505a7
Version: 6
Effective Time: 20130625
 
Polygen Pharmaceuticals LLC