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Name:Naproxen Sodium
Manufacturer:Dr.reddy's Laboratories Limited
Category:Over-the-counter (OTC) Marketed Drugs


NAPROXEN SODIUM TABLETS USP, 220 mg

NAPROXEN SODIUM - naproxen sodium tablet, coated 
Dr.Reddy's Laboratories Limited

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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)1


1
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

capletcontainer

Container Carton

capletcarton

Tablets

Container

tabletcontainer

Container Carton

tabletcarton


NAPROXEN SODIUM 
naproxen sodium tablet, coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:55111-272
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Naproxen Sodium (Naproxen) Naproxen Sodium 220 mg
Inactive Ingredients
Ingredient Name Strength
FD&C BLUE NO. 2  
hypromelloses  
magnesium stearate  
cellulose, microcrystalline  
polyethylene glycol  
povidone  
talc  
titanium dioxide  
POLYSORBATE 80  
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 9mm
Flavor Imprint Code R;272
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55111-272-24 1 BOTTLE ( BOTTLE) in 1 CARTON contains a BOTTLE
1 24 TABLET, COATED ( TABLET) in 1 BOTTLE This package is contained within the CARTON (55111-272-24)
2 NDC:55111-272-50 1 BOTTLE ( BOTTLE) in 1 CARTON contains a BOTTLE
2 50 TABLET, COATED ( TABLET) in 1 BOTTLE This package is contained within the CARTON (55111-272-50)
3 NDC:55111-272-01 1 BOTTLE ( BOTTLE) in 1 CARTON contains a BOTTLE
3 100 TABLET, COATED ( TABLET) in 1 BOTTLE This package is contained within the CARTON (55111-272-01)
4 NDC:55111-272-02 1 BOTTLE ( BOTTLE) in 1 CARTON contains a BOTTLE
4 200 TABLET, COATED ( TABLET) in 1 BOTTLE This package is contained within the CARTON (55111-272-02)
5 NDC:55111-272-05 1 BOTTLE ( BOTTLE) in 1 CARTON contains a BOTTLE
5 500 TABLET, COATED ( TABLET) in 1 BOTTLE This package is contained within the CARTON (55111-272-05)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075168 07/29/1998

NAPROXEN SODIUM 
naproxen sodium tablet, coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:55111-273
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Naproxen Sodium (Naproxen) Naproxen Sodium 220 mg
Inactive Ingredients
Ingredient Name Strength
FD&C BLUE NO. 2  
hypromelloses  
magnesium stearate  
cellulose, microcrystalline  
polyethylene glycol  
povidone  
talc  
titanium dioxide  
POLYSORBATE 80  
Product Characteristics
Color WHITE Score no score
Shape CAPSULE Size 12mm
Flavor Imprint Code R;273
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55111-273-24 1 BOTTLE ( BOTTLE) in 1 CARTON contains a BOTTLE
1 24 TABLET, COATED ( TABLET) in 1 BOTTLE This package is contained within the CARTON (55111-273-24)
2 NDC:55111-273-50 1 BOTTLE ( BOTTLE) in 1 CARTON contains a BOTTLE
2 50 TABLET, COATED ( TABLET) in 1 BOTTLE This package is contained within the CARTON (55111-273-50)
3 NDC:55111-273-01 1 BOTTLE ( BOTTLE) in 1 CARTON contains a BOTTLE
3 100 TABLET, COATED ( TABLET) in 1 BOTTLE This package is contained within the CARTON (55111-273-01)
4 NDC:55111-273-02 1 BOTTLE ( BOTTLE) in 1 CARTON contains a BOTTLE
4 200 TABLET, COATED ( TABLET) in 1 BOTTLE This package is contained within the CARTON (55111-273-02)
5 NDC:55111-273-40 1 BOTTLE ( BOTTLE) in 1 CARTON contains a BOTTLE
5 400 TABLET, COATED ( TABLET) in 1 BOTTLE This package is contained within the CARTON (55111-273-40)
6 NDC:55111-273-05 1 BOTTLE ( BOTTLE) in 1 CARTON contains a BOTTLE
6 500 TABLET, COATED ( TABLET) in 1 BOTTLE This package is contained within the CARTON (55111-273-05)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075168 07/29/1998

Labeler - Dr.Reddy's Laboratories Limited (862179079)

Revised: 11/2010 Dr.Reddy's Laboratories Limited



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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