FDA Label for Naproxen Sodium

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 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

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