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Naproxen Sodium by Dr.Reddy's Laboratories Limited

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

Medically reviewed on Nov 15, 2018

Further information

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

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