NAPROXEN- naproxen sodium tablet, film coated

Naproxen by

Drug Labeling and Warnings

Naproxen by is a Otc medication manufactured, distributed, or labeled by Amerisource Bergen, LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each caplet)

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

Purpose

Pain reliever/fever reducer

Uses

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

Warnings

Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

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

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]
  
• take more or for a longer time than directed
  
• have 3 or more alcoholic drinks every day while using this product
  

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 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 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 (1-800-222-1222) 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
  
• adults and children 12 years and older
  
  • take 1 caplet every 8 to 12 hours while symptoms last
    
  • for the first dose you may take 2 caplets within the first hour
    
  • do not exceed 2 caplets in any 8- to 12-hour period
    
  • do not exceed 3 caplets in a 24-hour period
    
• children under 12 years: ask a doctor
  

Other information

• each caplet contains: sodium 20 mg
  
• store at 20°-25°C (68°-77°F). Avoid high humidity and excessive heat above 40°C (104°F)
  
• see end flap for expiration date and lot number
  

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

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Compare to ALEVE® active ingredient†

NDC: 46122-564-78

Naproxen
naproxen sodium tablets 220 mg (NSAID)

Pain Reliever/Fever Reducer

Strength to last 12 hours

100 Caplets ι 220 mg Each

Actual Size

Distributed By
AmerisourceBergen
1300 Morris Drive
Chesterbrook, PA 19087
Questions or Concerns?
www.mygnp.com

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®.

50844     ORG051760412

GNP 44-604

INGREDIENTS AND APPEARANCE

NAPROXEN 
naproxen sodium tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 46122-564
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ)	NAPROXEN SODIUM	220 mg

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
POVIDONE (UNII: FZ989GH94E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	BLUE	Score	no score
Shape	OVAL	Size	12mm
Flavor		Imprint Code	44;604
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 46122-564-78	1 in 1 CARTON	02/01/2019
1		100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 46122-564-71	1 in 1 CARTON	02/01/2019
2		50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3	NDC: 46122-564-81	200 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA204872	02/01/2019

Labeler - Amerisource Bergen (007914906)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867894	MANUFACTURE(46122-564)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	PACK(46122-564)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	PACK(46122-564)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	PACK(46122-564)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		868734088	PACK(46122-564)