naproxen sodium tablets, usp 220 mg

naproxen sodium tablets, usp 220 mg
SPL v6
SPL
SPL Set ID e8720904-9ac0-46c0-b220-730e373505a7
Route
oral
Published
Effective Date 2012-06-11
Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients
naproxen (220 mg)
Inactive Ingredients
colloidal silicon dioxide croscarmellose sodium fd&c blue no. 2 hypromelloses magnesium stearate cellulose, microcrystalline povidone titanium dioxide polyethylene glycols

Identifiers & Packaging

Pill Appearance
Imprint: 144 Shape: round Shape: oval Color: blue Size: 10 mm Size: 12 mm Score: 1
Marketing Status
anda active Since 2012-11-13
Purpose

Pain reliever/Fever reducer 

Description

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

Medication Information

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
Purpose


Pain reliever/Fever reducer 



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 tablet every 8 to 12 hours while symptoms last
  • for the first dose you may take 2 tablets within the first hour
  • do not exceed 2 tablets in any 8- to 12-hour period
  • do not exceed 3 tablets in a 24-hour period
children under 12 years:

  • ask a doctor
Other Information
  • each tablet contains: sodium 20 mg
  • side effects occur. You may report side effects to PolyGen at 1-888-291-7337 and/ or FDA at 1-800-FDA-1088.
Inactive Ingredients


colloidal silicon dioxide, croscarmellose sodium, FD&C blue #2 lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycols, povidone, titanium dioxide.

 

Description

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

Principal Display Panel




NAPROXEN SODIUM TABLETS:  

Carton PDP:

NDC: 52605-141-01

Compare to the active ingredient in Aleve®

ALL DAY PAIN RELIEF

NAPROXEN SODIUM TABLETS, USP 220 mg

PAIN RELIEVER/ FEVER REDUCER (NSAID)

 

STRENGTH TO LAST 12 HOURS

100 TABLETS







Bottle Label PDP:

NDC: 52605-141-01

ALL DAY PAIN RELIEF

NAPROXEN SODIUM TABLETS, USP 220 mg

PAIN RELIEVER/ FEVER REDUCER (NSAID)

 

STRENGTH TO LAST 12 HOURS

100 TABLETS







NAPROXEN SODIUM CAPLETS:

 



Carton PDP:

 

NDC: 52605-144-01

 

Compare to the active ingredient in Aleve®

 

ALL DAY PAIN RELIEF

NAPROXEN SODIUM TABLETS, USP 220 mg

PAIN RELIEVER/ FEVER REDUCER (NSAID)

 

STRENGTH TO LAST 12 HOURS

 

100 CAPLETS (CAPSULE- SHAPED TABLETS)

 



 



Bottle Label PDP:

 

NDC: 52605-144-01

 

 

ALL DAY PAIN RELIEF

NAPROXEN SODIUM TABLETS, USP 220 mg

PAIN RELIEVER/ FEVER REDUCER (NSAID)

 

STRENGTH TO LAST 12 HOURS

 

100 CAPLETS (CAPSULE- SHAPED TABLETS)

 

 









NAPROXEN SODIUM CAPLETS:

 



Carton PDP:

 

NDC: 52605-144-24

 

Compare to the active ingredient in Aleve®

 

ALL DAY PAIN RELIEF

NAPROXEN SODIUM TABLETS, USP 220 mg

PAIN RELIEVER/ FEVER REDUCER (NSAID)

 

STRENGTH TO LAST 12 HOURS

 

24 CAPLETS (CAPSULE- SHAPED TABLETS)







 






Bottle Label PDP:

 

NDC: 52605-144-24

 

 

ALL DAY PAIN RELIEF

NAPROXEN SODIUM TABLETS, USP 220 mg

PAIN RELIEVER/ FEVER REDUCER (NSAID)

 

STRENGTH TO LAST 12 HOURS

 

24 CAPLETS (CAPSULE- SHAPED TABLETS)

















Use(s)


temporarily relieves minor aches and pains due to:

  • minor pain of arthritis
  • muscular aches
  • backache
  • menstrual cramps
  • headache
  • toothache
  • the common cold
  • temporarily reduces fever
Storage


store at 20-25°C (68-77°F) avoid high humidity and excessive heat above 40°C (104°F).

Do Not Use
  •  if you have ever had an allergic reaction to any other pain reliever/fever reducer
  •  right before or after heart surgery
Active Ingredient(s)


 Naproxen Sodium 220 mg (naproxen 200 mg) (NSAID)*

 *nonsteroidal anti-inflammatory drug

Questions Or Comments


1-800-291-7337



Pregnancy/breastfeeding


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.

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
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 are taking a diuretic
  • you have problems or serious side effects from taking pain relievers or fever reducers
  • you have asthma
Stop Use and Ask 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
  • 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 pill is stuck in your throat
Keep Out of Reach of Children




In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Ask A Doctor Or Pharmacist Before Use If
  • under a doctor's care for any serious condition
  • taking any other drug

Structured Label Content

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
Purpose


Pain reliever/Fever reducer 



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 tablet every 8 to 12 hours while symptoms last
  • for the first dose you may take 2 tablets within the first hour
  • do not exceed 2 tablets in any 8- to 12-hour period
  • do not exceed 3 tablets in a 24-hour period
children under 12 years:

  • ask a doctor
Other Information (Other information)
  • each tablet contains: sodium 20 mg
  • side effects occur. You may report side effects to PolyGen at 1-888-291-7337 and/ or FDA at 1-800-FDA-1088.
Inactive Ingredients (Inactive ingredients)


colloidal silicon dioxide, croscarmellose sodium, FD&C blue #2 lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycols, povidone, titanium dioxide.

 

Principal Display Panel




NAPROXEN SODIUM TABLETS:  

Carton PDP:

NDC: 52605-141-01

Compare to the active ingredient in Aleve®

ALL DAY PAIN RELIEF

NAPROXEN SODIUM TABLETS, USP 220 mg

PAIN RELIEVER/ FEVER REDUCER (NSAID)

 

STRENGTH TO LAST 12 HOURS

100 TABLETS







Bottle Label PDP:

NDC: 52605-141-01

ALL DAY PAIN RELIEF

NAPROXEN SODIUM TABLETS, USP 220 mg

PAIN RELIEVER/ FEVER REDUCER (NSAID)

 

STRENGTH TO LAST 12 HOURS

100 TABLETS







NAPROXEN SODIUM CAPLETS:

 



Carton PDP:

 

NDC: 52605-144-01

 

Compare to the active ingredient in Aleve®

 

ALL DAY PAIN RELIEF

NAPROXEN SODIUM TABLETS, USP 220 mg

PAIN RELIEVER/ FEVER REDUCER (NSAID)

 

STRENGTH TO LAST 12 HOURS

 

100 CAPLETS (CAPSULE- SHAPED TABLETS)

 



 



Bottle Label PDP:

 

NDC: 52605-144-01

 

 

ALL DAY PAIN RELIEF

NAPROXEN SODIUM TABLETS, USP 220 mg

PAIN RELIEVER/ FEVER REDUCER (NSAID)

 

STRENGTH TO LAST 12 HOURS

 

100 CAPLETS (CAPSULE- SHAPED TABLETS)

 

 









NAPROXEN SODIUM CAPLETS:

 



Carton PDP:

 

NDC: 52605-144-24

 

Compare to the active ingredient in Aleve®

 

ALL DAY PAIN RELIEF

NAPROXEN SODIUM TABLETS, USP 220 mg

PAIN RELIEVER/ FEVER REDUCER (NSAID)

 

STRENGTH TO LAST 12 HOURS

 

24 CAPLETS (CAPSULE- SHAPED TABLETS)







 






Bottle Label PDP:

 

NDC: 52605-144-24

 

 

ALL DAY PAIN RELIEF

NAPROXEN SODIUM TABLETS, USP 220 mg

PAIN RELIEVER/ FEVER REDUCER (NSAID)

 

STRENGTH TO LAST 12 HOURS

 

24 CAPLETS (CAPSULE- SHAPED TABLETS)

















Use(s)


temporarily relieves minor aches and pains due to:

  • minor pain of arthritis
  • muscular aches
  • backache
  • menstrual cramps
  • headache
  • toothache
  • the common cold
  • temporarily reduces fever
Storage


store at 20-25°C (68-77°F) avoid high humidity and excessive heat above 40°C (104°F).

Do Not Use (Do not use)
  •  if you have ever had an allergic reaction to any other pain reliever/fever reducer
  •  right before or after heart surgery
Active Ingredient(s) (Active ingredient(s))


 Naproxen Sodium 220 mg (naproxen 200 mg) (NSAID)*

 *nonsteroidal anti-inflammatory drug

Questions Or Comments (Questions or comments)


1-800-291-7337



Pregnancy/breastfeeding (Pregnancy/Breastfeeding)


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.

When Using This Product (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
Ask A Doctor Before Use If (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 are taking a diuretic
  • you have problems or serious side effects from taking pain relievers or fever reducers
  • you have asthma
Stop Use and Ask Doctor If (Stop use and ask 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
  • 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 pill is stuck in your throat
Keep Out of Reach of Children (Keep out of reach of children)




In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Ask A Doctor Or Pharmacist Before Use If (Ask a doctor or pharmacist before use if)
  • under a doctor's care for any serious condition
  • taking any other drug

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Source: dailymed · Ingested: 2026-02-15T11:55:38.754145 · Updated: 2026-03-14T22:53:30.775793