NAPROXEN SODIUM- naproxen sodium tablet 
NAPROXEN SODIUM- naproxen sodium tablet, film coated 
Granules India Ltd

----------

Naproxen Sodium Tablets, USP 220 mg

ACTIVE INGREDIENT(S)

(in each tablet/caplet)

Naproxen sodium 220 mg (Naproxen 200 mg) (NSAID)*

*nonsteroidal anti-inflammatory drug

PURPOSE

Pain reliever/fever reducer

USE(S)

• 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

Heart attack and stroke warning:

NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer 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 had high blood pressure, heart disease, liver cirrhosis,  kidney disease, asthma, or had a stroke
• you are taking a diuretic
• you have problems or serious side effects from taking pain relievers or fever reducers



ASK A DOCTOR OR PHARMACIST BEFORE USE IF

• 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

STOP USE AND ASK DOCTOR IF

• 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
• You have symptoms of heart problems or stroke: 
    •chest pain
    •trouble breathing 
    •weakness in one part or side of body
    •slurred speech
    •leg swelling
• 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



PREGNANCY/BREASTFEEDING

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 every 8 to 12 hours while symptoms last
  • for the first dose you may take 2 tablets within the first hour
  • do not exceed 2 tablets in any 8- to 12-hour period
  • do not exceed 3 tablets in a 24-hour period
Children under 12 years
  • ask a doctor

OTHER INFORMATION

•  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)



INACTIVE INGREDIENT

Inactive Ingredients 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 or Comments?

1-877-770-3183 Mon - Fri 9:00 AM to 4:30 PM EST 

Do not use if carton is open or of foil seal on bottle opening is missing or broken.

Manufactured By:
Granules India Limited
Hyderabad –500 081, India
MADE IN INDIA
M.L. 37/RR/AP/2003/F/R

PRINCIPAL DISPLAY PANEL

naproxen-327-49-jpgnaproxen-327-51-jpgnaproxen-328-49-jpgnaproxen-328-51-jpgnaproxen-762-49-jpg.jpgnaproxen-761-49-jpg.jpg	naproxen-729-49-jpg.jpgnaproxen-728-49-jpg.jpg

NAPROXEN SODIUM 
naproxen sodium tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62207-328
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
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
STARCH, CORN (UNII: O8232NY3SJ)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POVIDONE K30 (UNII: U725QWY32X)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Colorblue (Light Blue) Scoreno score
ShapeROUNDSize10mm
FlavorImprint Code 220
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62207-328-4124 in 1 BOTTLE; Type 0: Not a Combination Product07/16/2021
2NDC:62207-328-4250 in 1 BOTTLE; Type 0: Not a Combination Product07/16/2021
3NDC:62207-328-43100 in 1 BOTTLE; Type 0: Not a Combination Product07/16/2021
4NDC:62207-328-47500 in 1 BOTTLE; Type 0: Not a Combination Product07/16/2021
5NDC:62207-328-491000 in 1 BOTTLE; Type 0: Not a Combination Product07/16/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09135307/16/2021
NAPROXEN SODIUM 
naproxen sodium tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62207-327
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
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
STARCH, CORN (UNII: O8232NY3SJ)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POVIDONE K30 (UNII: U725QWY32X)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Colorblue (Light Blue) Scoreno score
ShapeOVAL (Caplet -Shaped) Size12mm
FlavorImprint Code 220
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62207-327-4124 in 1 BOTTLE; Type 0: Not a Combination Product07/16/2021
2NDC:62207-327-4250 in 1 BOTTLE; Type 0: Not a Combination Product07/16/2021
3NDC:62207-327-43100 in 1 BOTTLE; Type 0: Not a Combination Product07/16/2021
4NDC:62207-327-47500 in 1 BOTTLE; Type 0: Not a Combination Product07/16/2021
5NDC:62207-327-491000 in 1 BOTTLE; Type 0: Not a Combination Product07/16/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09135307/16/2021
NAPROXEN SODIUM 
naproxen sodium tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62207-761
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
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
STARCH, CORN (UNII: O8232NY3SJ)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POVIDONE K30 (UNII: U725QWY32X)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Colorblue (Light Blue) Scoreno score
ShapeROUNDSize9mm
FlavorImprint Code 220
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62207-761-4250 in 1 BOTTLE; Type 0: Not a Combination Product09/30/2011
2NDC:62207-761-43100 in 1 BOTTLE; Type 0: Not a Combination Product09/30/2011
3NDC:62207-761-47500 in 1 BOTTLE; Type 0: Not a Combination Product09/30/2011
4NDC:62207-761-491000 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, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62207-762
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
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
STARCH, CORN (UNII: O8232NY3SJ)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POVIDONE K30 (UNII: U725QWY32X)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Colorblue (Light Blue) Scoreno score
ShapeOVAL (Caplet -Shaped) Size12mm
FlavorImprint Code 220
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62207-762-4250 in 1 BOTTLE; Type 0: Not a Combination Product09/30/2011
2NDC:62207-762-43100 in 1 BOTTLE; Type 0: Not a Combination Product09/30/2011
3NDC:62207-762-47500 in 1 BOTTLE; Type 0: Not a Combination Product09/30/2011
4NDC:62207-762-491000 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:62207-728
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
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
STARCH, CORN (UNII: O8232NY3SJ)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POVIDONE K30 (UNII: U725QWY32X)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Colorblue (Light Blue) Scoreno score
ShapeROUNDSize10mm
FlavorImprint Code 220
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62207-728-2424 in 1 BOTTLE; Type 0: Not a Combination Product06/08/2018
2NDC:62207-728-4250 in 1 BOTTLE; Type 0: Not a Combination Product06/08/2018
3NDC:62207-728-43100 in 1 BOTTLE; Type 0: Not a Combination Product06/08/2018
4NDC:62207-728-47500 in 1 BOTTLE; Type 0: Not a Combination Product06/08/2018
5NDC:62207-728-491000 in 1 BOTTLE; Type 0: Not a Combination Product06/08/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09135306/08/2018
NAPROXEN SODIUM 
naproxen sodium tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62207-729
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
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
STARCH, CORN (UNII: O8232NY3SJ)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POVIDONE K30 (UNII: U725QWY32X)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Colorblue (Light Blue) Scoreno score
ShapeOVAL (Caplet -Shaped) Size12mm
FlavorImprint Code 220
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62207-729-2424 in 1 BOTTLE; Type 0: Not a Combination Product06/08/2018
2NDC:62207-729-4250 in 1 BOTTLE; Type 0: Not a Combination Product06/08/2018
3NDC:62207-729-43100 in 1 BOTTLE; Type 0: Not a Combination Product06/08/2018
4NDC:62207-729-47500 in 1 BOTTLE; Type 0: Not a Combination Product06/08/2018
5NDC:62207-729-491000 in 1 BOTTLE; Type 0: Not a Combination Product06/08/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09135306/08/2018
Labeler - Granules India Ltd (915000087)
Establishment
NameAddressID/FEIBusiness Operations
Granules India Ltd918609236manufacture(62207-728, 62207-729, 62207-761, 62207-762, 62207-327, 62207-328)

Revised: 2/2023
Document Id: f4026a0a-c9cd-3850-e053-2995a90a459c
Set id: 95ba1722-60ed-4a83-9f26-50c4de8cf180
Version: 9
Effective Time: 20230206
 
Granules India Ltd