Naproxen Sodium description, usages, side effects, indications, overdosage, supplying and lots more!

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Naproxen Sodium

Granules India Limited

Naproxen Sodium Tablets




FULL PRESCRIBING INFORMATION

Naproxen sodium 220 mg

(naproxen 200 mg) (NSAID)*

*nonsteroidal anti-inflammatory drug

Pain reliever/fever reducer

  • 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

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
  • if you have ever had an allergic reaction to any other pain reliever/fever reducer
  • right before or after heart surgery
  • 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
  • under a doctor’s care for any serious condition
  • taking any other drug
  • 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
  • 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

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.

In case of overdose, get medical help or contact a Poison Control Center right away.

  • 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 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 years ask a doctor
  • 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.

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

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

Naproxen SodiumNaproxen Sodium

Naproxen Sodium

Naproxen Sodium TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:62207-750
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
naproxen sodium NAPROXEN 220 mg

Inactive Ingredients

Ingredient Name Strength
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

Color Size Imprint Code Shape
BLUE (Light Blue) 10 mm I1 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:62207-750-41 24 in 1 BOTTLE
2 NDC:62207-750-42 50 in 1 BOTTLE
3 NDC:62207-750-43 43 in 1 BOTTLE
4 NDC:62207-750-44 150 in 1 BOTTLE
5 NDC:62207-750-45 200 in 1 BOTTLE
6 NDC:62207-750-47 500 in 1 BOTTLE
7 NDC:62207-750-49 1000 in 1 BOTTLE
8 NDC:62207-750-51 10 in 1 BOTTLE
9 NDC:62207-750-52 300 in 1 BOTTLE
10 NDC:62207-750-53 400 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091353 2011-09-30


Naproxen Sodium

Naproxen Sodium TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:62207-753
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
naproxen sodium NAPROXEN 220 mg

Inactive Ingredients

Ingredient Name Strength
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

Color Size Imprint Code Shape
BLUE (Light Blue) 12 mm 220 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:62207-753-41 24 in 1 BOTTLE
2 NDC:62207-753-42 50 in 1 BOTTLE
3 NDC:62207-753-43 43 in 1 BOTTLE
4 NDC:62207-753-44 150 in 1 BOTTLE
5 NDC:62207-753-45 200 in 1 BOTTLE
6 NDC:62207-753-47 500 in 1 BOTTLE
7 NDC:62207-753-49 1000 in 1 BOTTLE
8 NDC:62207-753-51 10 in 1 BOTTLE
9 NDC:62207-753-52 300 in 1 BOTTLE
10 NDC:62207-753-53 400 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091353 2011-09-30


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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