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Name:Aleve
Manufacturer:Cardinal Health
Category:Over-the-counter (OTC) Marketed Drugs


Drug Facts

ALEVE - naproxen sodium tablet 
Cardinal Health

----------

Drug Facts

ALL DAY STRONG®

ALEVE®

naproxen sodium tablets,

220 mg (NSAID)

Pain reliever/fever reducer

STRENGTH TO LAST 12 HOURS

CAPSULE-SHAPED TABLETS

Active ingredient

Drug Facts

Active ingredient Purposes

(in each caplet)

Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)* ..............................Pain reliever/fever reducer

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Keep Out of Reach of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control

Center right away

Uses

Uses

■ 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 ■ asthma (wheezing) ■ skin reddening ■ blisters ■ facial swelling ■ shock ■ rash

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

Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (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 an NSAID (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 you have

■ problems or serious side effects from taking pain relievers or fever reducers

■ stomach problems that last or come back, such as heartburn, upset stomach, or stomach pain

■ ulcers ■ asthma

■ bleeding problems ■ high blood pressure

■ heart or kidney disease ■ taken a diuretic

■ reached age 60 or older

Ask a doctor or pharmacist before use if you are

■ taking any other drug containing an NSAID (prescription or nonprescription)

■ taking a blood thinning (anticoagulant) or steroid drug

■ 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 feel faint, vomit blood, or have bloody or black stools. These are signs of stomach bleeding.

■ pain gets worse or lasts for more than 10 days

■ fever gets worse or lasts for more than 3 days

■ you have difficulty swallowing

■ it feels like the pill is stuck in your throat

■ you develop heartburn

■ stomach pain or upset gets worse or lasts

■ 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.

Directions

Directions

■ do not take more than directed

■ the smallest effective dose should be used

■ do not take longer than 10 days, unless directed by a doctor (see Warnings)

■ drink a full glass of water with each dose

Adults and children 12 years ■ take 1 caplet every 8 to 12 hours while symptoms last

and older ■ 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 20-25°C (68-77°F). Avoid high humidity and excessive heat above 40°C (104°F).

Inactive Ingredients

Inactive ingredients FD&C blue #2 lake, hypromellose, magnesium stearate, microcrystalline

cellulose, polyethylene glycol, povidone, talc, titanium dioxide

Questions or comments?

1-800-395-0689 (Mon - Fri 9AM - 5PM EST) or www.aleve.com

Bayer, the Bayer Cross, Aleve and All Day Strong are registered trademarks of Bayer.

US Pats. 4,948,002 and D330,677.

Bayer HealthCare LLC

Consumer Care

P.O. Box 1910

Morristown, NJ 07962-1910 USA

MADE IN GERMANY

Cardinal Health

Zanesville, OH 43701

IU40283610410

Package/Label Principal Display Panel

Aleve®

(naproxen sodium) tablet

220 mg (NSAID)

Aleve

Principal Display Panel - Label

NDC 55154-4853-4

Aleve®

naproxen sodium tablets

220 mg (NSAID)

200 Caplets

Label


ALEVE 
naproxen sodium tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:55154-4853(NDC:25866-001)
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NAPROXEN SODIUM (NAPROXEN) NAPROXEN SODIUM 220 mg
Inactive Ingredients
Ingredient Name Strength
FD&C BLUE NO. 2  
HYPROMELLOSES  
MAGNESIUM STEARATE  
CELLULOSE, MICROCRYSTALLINE  
POLYETHYLENE GLYCOL 3350  
POVIDONE  
TALC  
TITANIUM DIOXIDE  
Product Characteristics
Color BLUE Score no score
Shape OVAL Size 14mm
Flavor Imprint Code ALEVE
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55154-4853-4 200 POUCH ( POUCH) in 1 CARTON contains a POUCH (55154-4853-6)
1 NDC:55154-4853-6 1 TABLET ( TABLET) in 1 POUCH This package is contained within the CARTON (55154-4853-4)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020204 01/11/1994

Labeler - Cardinal Health (188557102)
Establishment
Name Address ID/FEI Operations
Cardinal Health 188557102 REPACK

Revised: 05/2011 Cardinal Health



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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