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Naproxen Sodium by Granules India Limited

Medically reviewed on December 5, 2017

Dosage form: tablet
Ingredients: NAPROXEN SODIUM 220mg
Labeler: Granules India Limited
NDC Code: 62207-750

Naproxen Sodium Tablets

ACTIVE INGREDIENT

Naproxen sodium 220 mg

(naproxen 200 mg) (NSAID)*

*nonsteroidal anti-inflammatory drug

PURPOSE

Pain reliever/fever reducer

INDICATIONS AND USAGE
  • 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

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

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 DOCTOR
  • 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 DOCTOR/PHARMACIST
  • under a doctor’s care for any serious condition
  • taking any other drug

WHEN USING
  • 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
  • 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
  • you have difficulty swallowing
  • it feels like the pill is stuck in your throat
  • you develop heartburn
  • redness or swelling is present in the painful area
  • any new symptoms appear

PREGNANCY 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.

DOSAGE AND ADMINISTRATION
  • 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 oldertake 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 yearsask a doctor

Information for Patients
  • each tablet contains: sodium 20 mg
  • store at 20 - 25°C (68 - 77°F). Avoid high humidity and excessive heat above 40°C (104°F)
  • do not use if foil seal on bottle opening is missing or broken.

INACTIVE INGREDIENT

FD&C blue#2 aluminum lake, hypromellose 2910, maize starch, microcrystalline cellulose, polyethylene glycol, povidone k-30, sodium starch glycolate, stearic acid, titanium dioxide

QUESTIONS

1-877-770-3183 Mon – Fri 9:00 AM to 4:00 PM EST

M.L. 37/RR/AP/2003/F/R

MADE IN INDIA

Manufactured By:

Granules India Limited

2nd Floor 3rd Block, My Home hub

Madhapur, Hyderabad – 500 081, India

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NAPROXEN SODIUM 
naproxen sodium tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62207-750
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NAPROXEN SODIUM (NAPROXEN) NAPROXEN SODIUM220 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE 
STARCH, CORN 
POVIDONE K30 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
STEARIC ACID 
HYPROMELLOSES 
POLYETHYLENE GLYCOL 400 
TITANIUM DIOXIDE 
FD&C BLUE NO. 2 
Product Characteristics
ColorBLUE (Light Blue) Scoreno score
ShapeROUNDSize10mm
FlavorImprint CodeI1
Contains    
Packaging
#Item CodePackage Description
1NDC:62207-750-4124 TABLET (TABLET) in 1 BOTTLE
2NDC:62207-750-4250 TABLET (TABLET) in 1 BOTTLE
3NDC:62207-750-4343 TABLET (TABLET) in 1 BOTTLE
4NDC:62207-750-44150 TABLET (TABLET) in 1 BOTTLE
5NDC:62207-750-45200 TABLET (TABLET) in 1 BOTTLE
6NDC:62207-750-47500 TABLET (TABLET) in 1 BOTTLE
7NDC:62207-750-491000 TABLET (TABLET) in 1 BOTTLE
8NDC:62207-750-5110 TABLET (TABLET) in 1 BOTTLE
9NDC:62207-750-52300 TABLET (TABLET) in 1 BOTTLE
10NDC:62207-750-53400 TABLET (TABLET) in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09135309/30/2011
NAPROXEN SODIUM 
naproxen sodium tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62207-753
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NAPROXEN SODIUM (NAPROXEN) NAPROXEN SODIUM220 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE 
STARCH, CORN 
POVIDONE K30 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
STEARIC ACID 
HYPROMELLOSES 
POLYETHYLENE GLYCOL 400 
TITANIUM DIOXIDE 
FD&C BLUE NO. 2 
Product Characteristics
ColorBLUE (Light Blue) Scoreno score
ShapeOVAL (Capsule-Shaped) Size12mm
FlavorImprint Code220
Contains    
Packaging
#Item CodePackage Description
1NDC:62207-753-4124 TABLET (TABLET) in 1 BOTTLE
2NDC:62207-753-4250 TABLET (TABLET) in 1 BOTTLE
3NDC:62207-753-4343 TABLET (TABLET) in 1 BOTTLE
4NDC:62207-753-44150 TABLET (TABLET) in 1 BOTTLE
5NDC:62207-753-45200 TABLET (TABLET) in 1 BOTTLE
6NDC:62207-753-47500 TABLET (TABLET) in 1 BOTTLE
7NDC:62207-753-491000 TABLET (TABLET) in 1 BOTTLE
8NDC:62207-753-5110 TABLET (TABLET) in 1 BOTTLE
9NDC:62207-753-52300 TABLET (TABLET) in 1 BOTTLE
10NDC:62207-753-53400 TABLET (TABLET) in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09135309/30/2011
Labeler - Granules India Limited (915000087)
Establishment
NameAddressID/FEIOperations
Granules India Limited918609236ANALYSIS, MANUFACTURE, PACK

 
Granules India Limited

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Further information

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

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