Naproxen Sodium

Dr.Reddy's Laboratories Limited

NAPROXEN SODIUM TABLETS USP, 220 mg

FULL PRESCRIBING INFORMATION: CONTENTS*

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FULL PRESCRIBING INFORMATION

PAIN RELIEVER / FEVER REDUCER (NSAID)

Drug Facts

Naproxen sodium USP, 220 mg
(naproxen USP, 200 mg) (NSAID)nonsteroidal anti-inflammatory drug

Pain reliever/fever reducer

• temporarily relieves minor aches and pains due to:
  • minor pain of arthritis
  • backache
  • headache
  • the common cold
  • muscular aches
  • menstrual cramps
  • toothache
• temporarily reduces fever

Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

• hives
• asthma (wheezing)
• skin reddening
• facial swelling
• shock
• 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 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 NSAID's (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 you are

• 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 a doctor if

• you experience any of the following signs ofstomach 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
• redness or swelling is present in the painful area
• any new symptoms appear

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.

• do not take more than directed
• the smallest effective dose should be used
• drink a full glass of water with each dose

• each tablet/caplet contains: sodium 20 mg
• store at 20-25°C (68-77°F). Avoid high humidity and excessive heat above 40°C (104°F).

FD&C blue no. 2, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, talc, titanium dioxide

call 1-888-375-3784

^{Manufactured by:}

Dr. Reddy’s Laboratories Limited

Bachepalli - 502 325 INDIA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

Caplets

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Container Carton

Tablets

Container

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