NAPROXEN- naproxen sodium tablet 
Proficient Rx LP

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Naproxen Sodium 220mg

Active ingredient (in each tablet)

Naproxen sodium 220 mg
(Naproxen 200 mg) (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/ fever reducer

Uses

temporarily relieves minor aches and pain due to:

temporarily reduces fever

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:

Heart attack and stroke warning:NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.

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

 leg swelling  chest pain
 slurred speech  trouble breathing
 weakness in one part or side of body

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

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

Directions

Storage

Other information

Inactive ingredients

croscarmellose sodium, FD&C blue #2 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl
alcohol, povidone, silicon dioxide, talc, titanium dioxide

Questions or comments?

Call 1-800-540-3765

Principal Display Panel

71205-595-24
NAPROXEN 
naproxen sodium tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71205-595(NDC:57896-954)
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TALC (UNII: 7SEV7J4R1U)  
Product Characteristics
ColorblueScoreno score
ShapeROUNDSize10mm
FlavorImprint Code 44;417
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71205-595-2424 in 1 BOTTLE; Type 0: Not a Combination Product07/28/2023
2NDC:71205-595-3030 in 1 BOTTLE; Type 0: Not a Combination Product07/27/2021
3NDC:71205-595-6060 in 1 BOTTLE; Type 0: Not a Combination Product07/27/2021
4NDC:71205-595-9090 in 1 BOTTLE; Type 0: Not a Combination Product07/27/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20487201/01/2019
Labeler - Proficient Rx LP (079196022)
Establishment
NameAddressID/FEIBusiness Operations
Proficient Rx LP079196022repack(71205-595) , relabel(71205-595)

Revised: 7/2023
Document Id: 0193d608-f4a8-5a69-e063-6294a90aafe8
Set id: 2acd8e24-449d-4f5c-9323-504013ff4bf5
Version: 3
Effective Time: 20230728
 
Proficient Rx LP