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Naproxen Sodium by Dr.Reddy's Laboratories Limited

Medically reviewed on November 15, 2017

Dosage form: tablet, coated
Ingredients: Naproxen Sodium 220mg
Labeler: Dr.Reddy's Laboratories Limited
NDC Code: 55111-272

NAPROXEN SODIUM 
TABLETS USP, 220 mg

PAIN RELIEVER / FEVER REDUCER (NSAID)

Drug Facts

Active ingredient (in each tablet/caplet)

Naproxen sodium USP, 220 mg
(naproxen USP, 200 mg) (NSAID)


nonsteroidal anti-inflammatory drug

Purposes

Pain reliever/fever reducer

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

Warnings

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

  • hives
  • asthma (wheezing)
  • skin reddening
  • facial swelling
  • shock
  • 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 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 NSAID's (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

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 are taking a diuretic
  • you have problems or serious side effects from taking pain relievers or fever reducers
  • you have asthma

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 ofstomach 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
  • 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 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 tablet/caplet every 8 to 12 hours while symptoms last
  • for the first dose you may take 2 tablets/caplets within the first hour
  • do not exceed 2 tablets/caplets in any 8- to 12-hour period
  • do not exceed 3 tablets/caplets in a 24-hour period
Children under 12 years
  • ask a doctor

Other information
  • each tablet/caplet contains: sodium 20 mg
  • store at 20-25°C (68-77°F). Avoid high humidity and excessive heat above 40°C (104°F).

Inactive ingredients

FD&C blue no. 2, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, talc, titanium dioxide

Questions?

call 1-888-375-3784

Manufactured by:

Dr. Reddy’s Laboratories Limited

Bachepalli - 502 325 INDIA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

Caplets

Container

Container Carton

Tablets

Container

Container Carton

NAPROXEN SODIUM 
naproxen sodium tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55111-272
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Naproxen Sodium (Naproxen) Naproxen Sodium220 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 2 
hypromelloses 
magnesium stearate 
cellulose, microcrystalline 
polyethylene glycol 
povidone 
talc 
titanium dioxide 
POLYSORBATE 80 
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize9mm
FlavorImprint CodeR;272
Contains    
Packaging
#Item CodePackage Description
1NDC:55111-272-241 BOTTLE (BOTTLE) in 1 CARTON
124 TABLET, COATED (TABLET) in 1 BOTTLE
2NDC:55111-272-501 BOTTLE (BOTTLE) in 1 CARTON
250 TABLET, COATED (TABLET) in 1 BOTTLE
3NDC:55111-272-011 BOTTLE (BOTTLE) in 1 CARTON
3100 TABLET, COATED (TABLET) in 1 BOTTLE
4NDC:55111-272-021 BOTTLE (BOTTLE) in 1 CARTON
4200 TABLET, COATED (TABLET) in 1 BOTTLE
5NDC:55111-272-051 BOTTLE (BOTTLE) in 1 CARTON
5500 TABLET, COATED (TABLET) in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07516807/29/1998
NAPROXEN SODIUM 
naproxen sodium tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55111-273
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Naproxen Sodium (Naproxen) Naproxen Sodium220 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 2 
hypromelloses 
magnesium stearate 
cellulose, microcrystalline 
polyethylene glycol 
povidone 
talc 
titanium dioxide 
POLYSORBATE 80 
Product Characteristics
ColorWHITEScoreno score
ShapeCAPSULESize12mm
FlavorImprint CodeR;273
Contains    
Packaging
#Item CodePackage Description
1NDC:55111-273-241 BOTTLE (BOTTLE) in 1 CARTON
124 TABLET, COATED (TABLET) in 1 BOTTLE
2NDC:55111-273-501 BOTTLE (BOTTLE) in 1 CARTON
250 TABLET, COATED (TABLET) in 1 BOTTLE
3NDC:55111-273-011 BOTTLE (BOTTLE) in 1 CARTON
3100 TABLET, COATED (TABLET) in 1 BOTTLE
4NDC:55111-273-021 BOTTLE (BOTTLE) in 1 CARTON
4200 TABLET, COATED (TABLET) in 1 BOTTLE
5NDC:55111-273-401 BOTTLE (BOTTLE) in 1 CARTON
5400 TABLET, COATED (TABLET) in 1 BOTTLE
6NDC:55111-273-051 BOTTLE (BOTTLE) in 1 CARTON
6500 TABLET, COATED (TABLET) in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07516807/29/1998
Labeler - Dr.Reddy's Laboratories Limited (862179079)

 
Dr.Reddy's Laboratories Limited

← See all Naproxen Sodium brands

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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