NAPROXEN SODIUM- naproxen sodium tablet 
Kinray

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Drug Facts

Active ingredient (in each caplet)

Naproxen sodium, USP 220 mg (naproxen 200 mg) (NSAID)**
**nonsteroidal anti-inflammatory drug

Purposes

Pain reliever/ fever reducer

Uses

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 you are

When using this product

Stop use and ask a doctor if

you experience any of the following signs of stomach bleeding:

If pregnant or breast-feeding

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 caplet every 8 to 12 hours while symptoms last
  • for the first dose you may take 2 caplets within the first hour
  • do not exceed 2 caplets in any 8 to 12 hour period
  • do not exceed 3 caplets in a 24-hour period
Children under 12 years
  • ask a doctor

Other Information

Inactive Ingredients:

croscarmellose sodium, FD&C blue #2, macrogol, magnesium stearate, polyvinyl alcohol, povidone, pregelatinized starch, talc, and titanium dioxide

Questions or comments? 1-877-586-7979

PRINCIPAL DISPLAY PANEL - 220 mg TABLET CARTON

Preferred Plus Pharmacy

NDC 61715-060-50

SEE NEW WARNINGS INFORMATION

*Compare to the Active Ingredient in Aleve®

Naproxen Sodium Tablets, USP 220 mg

 Pain Reliever/Fever Reducer (NSAID)

50 COATED CAPLETS†

†CAPSULE-SHAPED TABLETS

Distributed By:

Kinray, Inc., Whitestone, NY 11357

(c) 2013 Kinray Inc., All Rights Reserved, PREFERRED PLUS, PREFERRED PLUS ++++ and the PREFERRED PLUS logo are trademarks and/or registered trademarks of Kinray Inc. All other marks are property of their respective owners.

image description

NAPROXEN SODIUM 
naproxen sodium tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61715-060
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ) NAPROXEN SODIUM220 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYVINYL ALCOHOL (UNII: 532B59J990)  
POVIDONE (UNII: FZ989GH94E)  
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorblueScoreno score
ShapeOVAL (Capsule-Shaped) Size12mm
FlavorImprint Code 17
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61715-060-501 in 1 CARTON
150 in 1 BOTTLE, PLASTIC
2NDC:61715-060-511 in 1 CARTON
2100 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07909611/25/2009
Labeler - Kinray (012574513)
Registrant - Aphena Pharma Solutions - Kentucky, LLC (557054835)
Establishment
NameAddressID/FEIBusiness Operations
Aphena Pharma Solutions - Kentucky, LLC557054835repack(61715-060)
Establishment
NameAddressID/FEIBusiness Operations
Amneal Pharmaceuticals831227801manufacture(61715-060)

Revised: 5/2013
Document Id: 02d3fae4-c0a8-4071-9ac1-8b10028f400c
Set id: e1ea637b-9586-40ba-8729-a1d22690a627
Version: 1
Effective Time: 20130530
 
Kinray