FDA Label for Naproxen Sodium

Active Ingredient (In Each Caplet)

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

Purposes

Pain reliever/ fever reducer

Uses

• temporarily relieves minor aches and pain 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 everyday 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 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
• 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. (1-800-222-1222)

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 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

Other Information

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

Inactive Ingredients:

croscarmellose sodium, FD&C blue #2, macrogol, magnesium stearate, polyvinyl alcohol, povidone, pregelatinized starch, talc, and titanium dioxide

Questions Or Comments? 1-877-586-7979

Principal Display Panel - 220 Mg Tablet Carton

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Preferred Plus Pharmacy

NDC 61715-060-50

SEE NEW WARNINGS INFORMATION

*Compare to the Active Ingredient in Aleve®

Naproxen Sodium Tablets, USP 220 mg

 Pain Reliever/Fever Reducer (NSAID)

50 COATED CAPLETS†

†CAPSULE-SHAPED TABLETS

Distributed By:

Kinray, Inc., Whitestone, NY 11357

(c) 2013 Kinray Inc., All Rights Reserved, PREFERRED PLUS, PREFERRED PLUS ++++ and the PREFERRED PLUS logo are trademarks and/or registered trademarks of Kinray Inc. All other marks are property of their respective owners.