NAPROXEN SODIUM- naproxen sodium tablet, film coated 
Rite Aid Corporation

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Rite Aid 44-604

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 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
  • you are taking a diuretic

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
  • 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

NDC 11822-6040-6

Compare to the 
active ingredient of
Aleve® Caplets

STRENGTH TO LAST 12 HOURS

NAPROXEN
SODIUM

NAPROXEN SODIUM
TABLETS, 220 mg

PAIN RELIEVER/
FEVER REDUCER
(NSAID)

ACTUAL SIZE

200
CAPLETS**
**capsule-shaped tablets

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® Caplets.
50844   REV1221A60415

DISTRIBUTED BY: RITE AID,
200 NEWBERRY COMMONS
ETTERS, PA 17319 www.riteaid.com

SATISFACTION
GUARANTEE
If you're not satisfied, we'll
happily refund your money.Rite aid 44-604

Rite aid 44-604

NAPROXEN SODIUM 
naproxen sodium tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-6040
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:11822-6040-61 in 1 CARTON07/18/2022
1200 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:11822-6040-81 in 1 CARTON07/18/2022
224 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3NDC:11822-6040-51 in 1 CARTON07/18/2022
350 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
4NDC:11822-6040-7270 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/18/2022
5NDC:11822-6040-91 in 1 CARTON07/18/2022
590 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
6NDC:11822-6040-21 in 1 CARTON07/18/202201/03/2025
6100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20487207/18/2022
Labeler - Rite Aid Corporation (014578892)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464pack(11822-6040)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837manufacture(11822-6040) , pack(11822-6040)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894manufacture(11822-6040)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305pack(11822-6040)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.117025878manufacture(11822-6040)

Revised: 5/2024
Document Id: 52c8f256-62fa-4131-a295-ed80db084c64
Set id: e6277515-c606-4535-9c29-08cade045aee
Version: 5
Effective Time: 20240531
 
Rite Aid Corporation