Naproxen Sodium

MARKSANS PHARMA LIMITED

NAPROXEN SODIUM- naproxen sodium tablet, coatedMarksans Pharma Limited

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredient(s)
• Purpose
• Use(s)
• Warnings
• Do not use
• Ask a doctor before use if
• Ask a doctor or pharmacist before use if
• When using this product
• Stop use and ask doctor if
• Pregnancy/Breastfeeding
• Keep out of reach of children
• Directions
• Storage
• Naproxen Sodium Other information
• Inactive ingredients
• Manufactured for
• Manufactured by
• Principal Display Panel

FULL PRESCRIBING INFORMATION

Active ingredient(s)

Purpose

Pain reliever/ fever reducer

Use(s)

 temporarily relieves minor aches and pain due to:

• backache
• headache
• menstrual cramps
• minor pain of arthritis
• muscular aches
• the common cold
• toothache
• temporarily reduces fever

Warnings

• asthma (wheezing)
• blisters
• facial swelling
• hives
• rash
• shock
• skin reddening

If an allergic reaction occurs, stop use and seek medical help right away.

• are age 60 or older
• have bad stomach ulcers or bleeding problems
• take a blood thinning (anticoagulant) or steroid drug
• take other drug 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 a doctor before use if

• 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 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
• the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

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 a stomach pain that dose 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 sluck in your throat
• redness or swelling is present in the painful area
• any new symptoms appear

Pregnancy/Breastfeeding

ask health professional before use. It is especially important not to use naproxen sodium during the last 3 months of the 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 more than directed
• the smallest effective dose should be used
• drink a full glass of water with each dose

Storage

• Store at 20-25^oC (68-77^oF). Avoid high humidity and excessive heat above 40⁰C (104⁰F)

Naproxen Sodium Other information

• each tablet contain: sodium 20 mg
• Side effects occur. You may report side effects to FDA at 1-800-FDA-1088.

Inactive ingredients

Colloidal silicon dioxide, croscarmellose sodium, FD&C blue #2 lake, Hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone,  titanium dioxide.

Manufactured for

Marksans Pharma Inc.

Lake Grove, NY11755, USA

Manufactured by

Marksans Pharma Ltd.

Verna, Goa-403722, India

Mfg. Lic. No. GO/ Drugs/515

Principal Display Panel