OTC Medication Information: Naproxen Sodium

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

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

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NAPROXEN SODIUM naproxen sodium tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:62207-328
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
STARCH, CORN
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL 400
POVIDONE K30
SODIUM STARCH GLYCOLATE TYPE A POTATO
STEARIC ACID
TITANIUM DIOXIDE
Product Characteristics
Color blue (Light Blue) Score no score
Shape ROUND Size 10mm
Flavor Imprint Code 220
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62207-328-41 24 TABLET in 1 BOTTLE None
2 NDC:62207-328-42 50 TABLET in 1 BOTTLE None
3 NDC:62207-328-43 100 TABLET in 1 BOTTLE None
4 NDC:62207-328-47 500 TABLET in 1 BOTTLE None
5 NDC:62207-328-49 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091353 07/16/2021
NAPROXEN SODIUM naproxen sodium tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:62207-327
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
STARCH, CORN
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL 400
POVIDONE K30
SODIUM STARCH GLYCOLATE TYPE A POTATO
STEARIC ACID
TITANIUM DIOXIDE
Product Characteristics
Color blue (Light Blue) Score no score
Shape OVAL (Caplet -Shaped) Size 12mm
Flavor Imprint Code 220
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62207-327-41 24 TABLET in 1 BOTTLE None
2 NDC:62207-327-42 50 TABLET in 1 BOTTLE None
3 NDC:62207-327-43 100 TABLET in 1 BOTTLE None
4 NDC:62207-327-47 500 TABLET in 1 BOTTLE None
5 NDC:62207-327-49 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091353 07/16/2021
NAPROXEN SODIUM naproxen sodium tablet, film coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:62207-761
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
STARCH, CORN
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL 400
POVIDONE K30
SODIUM STARCH GLYCOLATE TYPE A POTATO
STEARIC ACID
TITANIUM DIOXIDE
Product Characteristics
Color blue (Light Blue) Score no score
Shape ROUND Size 9mm
Flavor Imprint Code 220
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62207-761-42 50 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:62207-761-43 100 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:62207-761-47 500 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:62207-761-49 1000 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091353 09/30/2011
NAPROXEN SODIUM naproxen sodium tablet, film coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:62207-762
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
STARCH, CORN
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL 400
POVIDONE K30
SODIUM STARCH GLYCOLATE TYPE A POTATO
STEARIC ACID
TITANIUM DIOXIDE
Product Characteristics
Color blue (Light Blue) Score no score
Shape OVAL (Caplet -Shaped) Size 12mm
Flavor Imprint Code 220
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62207-762-42 50 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:62207-762-43 100 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:62207-762-47 500 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:62207-762-49 1000 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091353 09/30/2011
NAPROXEN SODIUM naproxen sodium tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:62207-728
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
STARCH, CORN
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL 400
POVIDONE K30
SODIUM STARCH GLYCOLATE TYPE A POTATO
STEARIC ACID
TITANIUM DIOXIDE
Product Characteristics
Color blue (Light Blue) Score no score
Shape ROUND Size 10mm
Flavor Imprint Code 220
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62207-728-24 24 TABLET in 1 BOTTLE None
2 NDC:62207-728-42 50 TABLET in 1 BOTTLE None
3 NDC:62207-728-43 100 TABLET in 1 BOTTLE None
4 NDC:62207-728-47 500 TABLET in 1 BOTTLE None
5 NDC:62207-728-49 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091353 06/08/2018
NAPROXEN SODIUM naproxen sodium tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:62207-729
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
STARCH, CORN
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL 400
POVIDONE K30
SODIUM STARCH GLYCOLATE TYPE A POTATO
STEARIC ACID
TITANIUM DIOXIDE
Product Characteristics
Color blue (Light Blue) Score no score
Shape OVAL (Caplet -Shaped) Size 12mm
Flavor Imprint Code 220
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62207-729-24 24 TABLET in 1 BOTTLE None
2 NDC:62207-729-42 50 TABLET in 1 BOTTLE None
3 NDC:62207-729-43 100 TABLET in 1 BOTTLE None
4 NDC:62207-729-47 500 TABLET in 1 BOTTLE None
5 NDC:62207-729-49 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091353 06/08/2018
Labeler — Granules India Ltd (915000087)
Establishment
Name Address ID/FEI Operations
Granules India Ltd 918609236 manufacture (62207-728), manufacture (62207-729), manufacture (62207-761), manufacture (62207-762), manufacture (62207-327), manufacture (62207-328)

Revised: 02/2023 Granules India Ltd

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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