NAPROXEN BACK AND MUSCLE PAIN- naproxen sodium tablet, film coated 
L.N.K. International, Inc.

----------

Quality Plus 44-417 Back and Muscle Pain

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

Principal display panel

QUALITY
+PLUS

NDC 50844-714-16

Compare to
active ingredient in
Aleve® Back & Muscle
Pain Tablets

NAPROXEN
BACK AND MUSCLE PAIN

NAPROXEN SODIUM
TABLETS, 220 mg

PAIN RELIEVER/FEVER
REDUCER (NSAID)

For temporary relief of minor back
and muscle aches and pains

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®
Back & Muscle Pain Tablets.               50844     REV1221B41716

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

Quality Plus 44-417 BM

Quality Plus 44-417 BM

NAPROXEN BACK AND MUSCLE PAIN 
naproxen sodium tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50844-714
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:50844-714-998 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/01/2019
2NDC:50844-714-988 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/01/2019
3NDC:50844-714-191 in 1 CARTON02/01/2019
38 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
4NDC:50844-714-5625 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/01/2019
5NDC:50844-714-14500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/01/2019
6NDC:50844-714-161000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20487202/01/2019
Labeler - L.N.K. International, Inc. (038154464)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464pack(50844-714)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837manufacture(50844-714)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894manufacture(50844-714)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305pack(50844-714)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.117025878manufacture(50844-714)

Revised: 3/2024
Document Id: 6ce42c19-feaa-4e8f-a2f1-ac9eb3a73b5e
Set id: 68944663-0dc0-4d3a-a36b-019061bdbfa0
Version: 9
Effective Time: 20240326
 
L.N.K. International, Inc.