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Naproxen Sodium by Granules India Limited

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

← See all Naproxen Sodium brands

Medically reviewed on Dec 5, 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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