NAPROXEN SODIUM- naproxen sodium capsule, liquid filled 
QUALITY CHOICE (Chain Drug Marketing Association)

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Drug Facts

Active ingredient (in each capsule)

Naproxen sodium 220 mg

(naproxen 200 mg) (NSAID)*

*nonsteroidal anti-inflammatory drug

Purposes

Pain reliever/fever reducer

Uses

  • temporarily relieves minor aches and pains due to:
    • minor pain or arthritis
    • muscular aches
    • backache
    • menstrual cramps
    • headache
    • toothache
    • the common cold
  • temporarily reduces fever 

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
  • have 3 or more alcoholic drinks every day while using this product
  • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
  • take more or for a longer time 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, or kidney disease
  • you have problems or serious side effects from taking pain relievers or fever reducers
  • you have asthma
  • 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 any other drug

When using this product

  • take with food or milk if stomach upset occurs
  • the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

Stop use and ask a doctor if

  • you experience any of the following signs of stomach bleeding:
    • feel faint
    • have bloody or black stools
    • vomit blood
    • have stomach pain that does not get better
  • 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

  • do not take more than directed
  • the smallest effective dose should be used
  • drink a full glass of water with each dose
  • if taken with food, this product may take longer to work
  • 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

  • each capsule contains: sodium 20 mg
  • swallow whole; do not crush, chew or dissolve
  • store at 20-25°C (68-77°F). Avoid high humidity and excessive heat above 40°C (104°F).
  • read all warnings and directions before use. Keep carton.

Inactive ingredients

FD&C blue #1, gelatin, glycerin, lactic acid, mannitol, pharmaceutical ink, polyethylene glycol 600, povidone K30, propylene glycol, purified water, sorbitan, sorbitol

Questions or comments?

Call 1-248-449-9300 Monday-friday 9AM-5PM EST

Principal Display Panel

†Compare to the active ingredient in Aleve® Liquid Gels

Naproxen Sodium

Pain Reliever/Fever Reducer

Capsules, 220 mg (NSAID)

Liquid Gels (Liquid Filled Capsules)

†This product is not manufactured or distributed by Bayer HealthCare, LLC., owner of the registered trademark Aleve® Liquid Gels.

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Distributed by C.D.M.A., Inc.©

43157 W. Nine Mile

Novi, MI 48376-0995

www.qualitychoice.com

Product Label

Naproxen sodium 220 mg

Quality Choice Naproxen Sodium Liquid Gels

NAPROXEN SODIUM 
naproxen sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-123
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 600 (UNII: NL4J9F21N9)  
POVIDONE K30 (UNII: U725QWY32X)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SORBITAN (UNII: 6O92ICV9RU)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColorBLUEScoreno score
ShapeCAPSULESize21mm
FlavorImprint Code NPX
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63868-123-401 in 1 BOX10/31/201412/31/2020
140 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02192010/31/201412/31/2020
Labeler - QUALITY CHOICE (Chain Drug Marketing Association) (011920774)

Revised: 12/2018
 
QUALITY CHOICE (Chain Drug Marketing Association)