NAPROXEN SODIUM- naproxen sodium tablet, film coated 
L.N.K. International, Inc.

----------

Quality Plus 44-417 and 44-604

Active ingredient (in each tablet)

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

Purpose

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

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

  • 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 are taking a diuretic
  • you have a history of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke
  • you have problems or serious side effects from taking pain relievers or fever reducers

Ask a doctor or pharmacist before use if you are

  • under a doctor’s care for any serious condition
  • taking aspirin for heart attack or stroke, because naproxen may decrease this benefit of aspirin
  • taking any other drug

When using this product

  • take with food or milk if stomach upset occurs

Stop use and ask a doctor if

  • you experience any of the following signs of stomach bleeding:
    • feel faint
    • vomit blood
    • have bloody or black stools
    • have stomach pain that does not get better
  • you have symptoms of heart problems or stroke:
    • leg swelling
    • chest pain
    • slurred speech
    • trouble breathing
    • weakness in one part or side of body
  • pain gets worse or lasts more than 10 days
  • you have difficulty swallowing
  • any new symptoms appear
  • fever gets worse or lasts more than 3 days
  • it feels like the pill is stuck in your throat
  • redness or swelling is present in the painful area

If pregnant or breast-feeding,

ask a health professional before use. It is especially important not to use naproxen sodium at 20 weeks or later in 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

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 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday

Active ingredient (in each caplet)

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

Purpose

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

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

  • 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 are taking a diuretic
  • you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke
  • you have problems or serious side effects from taking pain relievers or fever reducers

Ask a doctor or pharmacist before use if you are

  • under a doctor’s care for any serious condition
  • taking aspirin for heart attack or stroke, because naproxen may decrease this benefit of aspirin
  • taking any other drug

When using this product

  • take with food or milk if stomach upset occurs

Stop use and ask a doctor if

  • you experience any of the following signs of stomach bleeding:
    • feel faint
    • vomit blood
    • have bloody or black stools
    • have stomach pain that does not get better
  • you have symptoms of heart problems or stroke:
    • slurred speech
    • trouble breathing
    • leg swelling
    • weakness in one part or side of body
    • chest pain
  • 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 stuck in your throat
  • redness or swelling is present in the painful area
  • any new symptoms appear

If pregnant or breast-feeding,

ask a health professional before use. It is especially important not to use naproxen sodium at 20 weeks or later in 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

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 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday

Principal display panel

QUALITY
+PLUS

NDC 50844-417-16

Compare to
active ingredient
in Aleve® Tablets

NAPROXEN
SODIUM
TABLETS, 220 mg

PAIN RELIEVER/
FEVER REDUCER (NSAID)

STRENGTH TO LAST
12 HOURS

1000
Coated Tablets

ACTUAL
SIZE

TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR
MISSING

This product is not manufactured or distributed by Bayer
HealthCare LLC, owner of the registered trademark Aleve® Tablets.
50844         REV1221C41716

Distributed by: LNK INTERNATIONAL, INC.
60 Arkay Drive, Hauppauge, NY 11788
USA

Quality Plus 44-417

Quality Plus 44-417

Principal display panel

QUALITY
+PLUS

NDC 50844-604-09

Compare to the active ingredient
in Menstridol ®

NAPROXEN SODIUM
TABLETS, 220 mg

PAIN RELIEVER/FEVER REDUCER (NSAID)

UP TO 12 HOURS OF MENSTRUAL PAIN RELIEF

Temporarily relieves minor cramps, backache, headache

20 Coated Caplets**
**CAPSULE-SHAPED TABLETS

ACTUAL
SIZE

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER
UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

This product is not manufactured or distributed by Bayer HealthCare LLC, owner
of the registered trademark Menstridol®.         50844           REV1221C60409

Distributed by: LNK INTERNATIONAL, INC.
60 Arkay Drive
Hauppauge, NY 11788
USA

Quality Plus 44-604

Quality Plus 44-604

NAPROXEN SODIUM 
naproxen sodium tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50844-417
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 ALUMINUM LAKE (UNII: 4AQJ3LG584)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorblueScoreno score
ShapeROUNDSize10mm
FlavorImprint Code 44;417
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50844-417-2248 in 1 CARTON02/01/2017
1NDC:50844-417-431 in 1 POUCH; Type 0: Not a Combination Product
2NDC:50844-417-1160 in 1 CARTON02/01/2017
2NDC:50844-417-431 in 1 POUCH; Type 0: Not a Combination Product
3NDC:50844-417-998 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/01/2017
4NDC:50844-417-988 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/01/2017
5NDC:50844-417-191 in 1 CARTON02/01/2017
58 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
6NDC:50844-417-5625 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/01/2017
7NDC:50844-417-14500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/01/2017
8NDC:50844-417-161000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/01/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20487202/01/2017
NAPROXEN SODIUM 
naproxen sodium tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50844-604
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 ALUMINUM LAKE (UNII: 4AQJ3LG584)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorblueScoreno score
ShapeOVALSize12mm
FlavorImprint Code 44;604
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50844-604-998 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/01/2017
2NDC:50844-604-988 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/01/2017
3NDC:50844-604-191 in 1 CARTON02/01/2017
38 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
4NDC:50844-604-5625 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/01/2017
5NDC:50844-604-14500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/01/2017
6NDC:50844-604-161000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/01/2017
7NDC:50844-604-094 in 1 CARTON02/01/2017
75 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20487202/01/2017
Labeler - L.N.K. International, Inc. (038154464)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464pack(50844-417, 50844-604)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837manufacture(50844-417, 50844-604) , pack(50844-604)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894manufacture(50844-417, 50844-604)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305pack(50844-417, 50844-604)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.117025878manufacture(50844-417, 50844-604)

Revised: 6/2024
Document Id: 1a1c53e1-fc4e-43de-940b-b487496519ab
Set id: 717518e4-2537-4229-b765-c6acfe963d4b
Version: 12
Effective Time: 20240627
 
L.N.K. International, Inc.