NAPROXEN SODIUM- naproxen sodium tablet 
Granules India Limited

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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

WARNINGS

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

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:

DO NOT USE

ASK DOCTOR

ASK DOCTOR/PHARMACIST

WHEN USING

STOP USE

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

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

C:\Users\Administrator\Desktop\spl sci\spl2\nap-sod capsule-shaped-tablets.jpgC:\Users\Administrator\Desktop\spl sci\spl2\nap-sod tablets.jpg

NAPROXEN SODIUM 
naproxen sodium tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62207-750
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ) NAPROXEN SODIUM220 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STARCH, CORN (UNII: O8232NY3SJ)  
POVIDONE K30 (UNII: U725QWY32X)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
Product Characteristics
Colorblue (Light Blue) Scoreno score
ShapeROUNDSize10mm
FlavorImprint Code I1
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62207-750-4124 in 1 BOTTLE; Type 0: Not a Combination Product09/30/2011
2NDC:62207-750-4250 in 1 BOTTLE; Type 0: Not a Combination Product09/30/2011
3NDC:62207-750-4343 in 1 BOTTLE; Type 0: Not a Combination Product09/30/2011
4NDC:62207-750-44150 in 1 BOTTLE; Type 0: Not a Combination Product09/30/2011
5NDC:62207-750-45200 in 1 BOTTLE; Type 0: Not a Combination Product09/30/2011
6NDC:62207-750-47500 in 1 BOTTLE; Type 0: Not a Combination Product09/30/2011
7NDC:62207-750-491000 in 1 BOTTLE; Type 0: Not a Combination Product09/30/2011
8NDC:62207-750-5110 in 1 BOTTLE; Type 0: Not a Combination Product09/30/2011
9NDC:62207-750-52300 in 1 BOTTLE; Type 0: Not a Combination Product09/30/2011
10NDC:62207-750-53400 in 1 BOTTLE; Type 0: Not a Combination Product09/30/2011
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 AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ) NAPROXEN SODIUM220 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STARCH, CORN (UNII: O8232NY3SJ)  
POVIDONE K30 (UNII: U725QWY32X)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
Product Characteristics
Colorblue (Light Blue) Scoreno score
ShapeOVAL (Capsule-Shaped) Size12mm
FlavorImprint Code 220
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62207-753-4124 in 1 BOTTLE; Type 0: Not a Combination Product09/30/2011
2NDC:62207-753-4250 in 1 BOTTLE; Type 0: Not a Combination Product09/30/2011
3NDC:62207-753-4343 in 1 BOTTLE; Type 0: Not a Combination Product09/30/2011
4NDC:62207-753-44150 in 1 BOTTLE; Type 0: Not a Combination Product09/30/2011
5NDC:62207-753-45200 in 1 BOTTLE; Type 0: Not a Combination Product09/30/2011
6NDC:62207-753-47500 in 1 BOTTLE; Type 0: Not a Combination Product09/30/2011
7NDC:62207-753-491000 in 1 BOTTLE; Type 0: Not a Combination Product09/30/2011
8NDC:62207-753-5110 in 1 BOTTLE; Type 0: Not a Combination Product09/30/2011
9NDC:62207-753-52300 in 1 BOTTLE; Type 0: Not a Combination Product09/30/2011
10NDC:62207-753-53400 in 1 BOTTLE; Type 0: Not a Combination Product09/30/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09135309/30/2011
Labeler - Granules India Limited (915000087)
Establishment
NameAddressID/FEIBusiness Operations
Granules India Limited918609236analysis(62207-750, 62207-753) , manufacture(62207-750, 62207-753) , pack(62207-750, 62207-753) , label(62207-750, 62207-753)

Revised: 12/2023
Document Id: 0c3a7f55-1cf1-e6bf-e063-6294a90afccb
Set id: 28d602d3-7f53-4575-848d-0670ea557d2a
Version: 7
Effective Time: 20231211
 
Granules India Limited