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 Type HUMAN OTC DRUG Item Code (Source) NDC:52605-141
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ) NAPROXEN SODIUM 220 mg
Inactive Ingredients
Ingredient Name Strength
COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POVIDONE (UNII: FZ989GH94E)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
Product Characteristics
Color BLUE Score no score
Shape ROUND Size 10mm
Flavor Imprint Code 141
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:52605-141-01 1 in 1 CARTON
1 100 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090545 06/11/2012
NAPROXEN SODIUM 
naproxen sodium tablet, coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:52605-144
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ) NAPROXEN SODIUM 220 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POVIDONE (UNII: FZ989GH94E)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
Product Characteristics
Color BLUE Score no score
Shape OVAL Size 12mm
Flavor Imprint Code 144
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:52605-144-01 1 in 1 CARTON
1 100 in 1 BOTTLE
2 NDC:52605-144-24 1 in 1 CARTON
2 24 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090545 11/13/2012
Labeler - Polygen Pharmaceuticals LLC (962415720)
Registrant - Polygen Pharmaceuticals LLC (962415720)
Establishment
Name Address ID/FEI Business Operations
Marksans Pharma Limited 925822975 MANUFACTURE(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