NAPROXEN SODIUM- naproxen sodium capsule, liquid filled 
WALGREEN COMPANY

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Drug Facts

Active ingredient (in each capsule)

Naproxen sodium 220 mg (naproxen 200 mg) (NSAID) 1


1
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:

  • hives
  • facial swelling
  • asthma (wheezing)
  • shock
  • skin reddening
  • rash
  • blisters

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:

  • are age 60 or older
  • have had stomach ulcers or bleeding problems
  • take a blood thinning (anticoagulant) or steroid drug
  • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
  • have 3 or more alcoholic drinks every day while using this product
  • take more or for a longer time than directed

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

  • 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 are taking a diuretic
  • 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:
  • chest pain
  • trouble breathing
  • weakness in one part or side of body
  • slurred speech
  • leg swelling
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present in the painful area
  • any new symptoms appear
  • you have difficulty swallowing
  • it feels like the capsule is stuck in your throat

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.

Directions

adults and children 12 years and older:
  • take 1 capsule every 8 to 12 hours while symptoms last
  • for the first dose you may take 2 capsules within the first hour
  • do not exceed 2 capsules in any 8- to 12-hour period
  • do not exceed 3 capsules in a 24-hour period
children under 12 years:
  • ask a doctor

Other information

Inactive ingredients

FD&C blue #1, gelatin, glycerin, lactic acid, mannitol, pharmaceutical ink, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol

Questions or comments?

1-888-235-2466 (Mon - Fri 9AM - 5PM EST)

DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS TORN OR MISSING

Walgreens Pharmacist Recommended Walgreens Pharmacist Survey

††This product is not manufactured or distributed by Bayer HealthCare, LLC, distributor of ALEVE ® Liquid Gels.

DISTRIBUTED BY:

WALGREEN CO.,

200 WILMOT RD.,

DEERFIELD, IL 60015

100% SATISFACTION GUARANTEED

walgreens.com ©2019 Walgreen Co.

ITEM 295751 W00000-0000-0

R0820

ORG0719-F

L0000367

PRINCIPAL DISPLAY PANEL - 220 mg Capsule Bottle Carton

Compare to ALEVE ® Liquid Gels active ingredient ††

NDC 0363-0177-11

Naproxen Sodium

CAPSULES, 220 mg (NSAID) /

PAIN RELIEVER / FEVER REDUCER

12 HOUR  LIQUID GELS

20 LIQUID-FILLED CAPSULES**

(**LIQUID GELS)

40's Count

NAPROXEN SODIUM 
naproxen sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0177
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
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
LACTIC ACID (UNII: 33X04XA5AT)  
MANNITOL (UNII: 3OWL53L36A)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SORBITAN (UNII: 6O92ICV9RU)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
Colorblue (Blue with white text) Scoreno score
ShapeCAPSULESize25mm
FlavorImprint Code NP1
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-0177-111 in 1 CARTON08/02/2019
120 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:0363-0177-151 in 1 CARTON08/02/2019
240 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3NDC:0363-0177-781 in 1 CARTON08/02/2019
380 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
4NDC:0363-0177-221 in 1 CARTON08/02/2019
4120 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
5NDC:0363-0177-25180 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/02/2019
6NDC:0363-0177-9980 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/02/2019
7NDC:0363-0177-161 in 1 CARTON04/30/2020
750 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02192008/02/2019
Labeler - WALGREEN COMPANY (008965063)
Registrant - Bionpharma Inc. (079637826)
Establishment
NameAddressID/FEIBusiness Operations
Patheon Softgels Inc.002193829manufacture(0363-0177)

Revised: 5/2021
Document Id: c1c1a698-3b20-3b0a-e053-2a95a90a206c
Set id: 462a7e41-b899-4e08-8113-b48ece0ad8d8
Version: 3
Effective Time: 20210507
 
WALGREEN COMPANY