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Aleve by Cardinal Health

Dosage form: tablet
Ingredients: NAPROXEN SODIUM 220mg
Labeler: Cardinal Health
NDC Code: 55154-4853

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)

Principal Display Panel - Label

NDC 55154-4853-4

Aleve®

naproxen sodium tablets

220 mg (NSAID)

200 Caplets

ALEVE 
naproxen sodium tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-4853(NDC:25866-001)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NAPROXEN SODIUM (NAPROXEN) NAPROXEN SODIUM220 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 2 
HYPROMELLOSES 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOL 3350 
POVIDONE 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorBLUEScoreno score
ShapeOVALSize14mm
FlavorImprint CodeALEVE
Contains    
Packaging
#Item CodePackage Description
1NDC:55154-4853-4200 POUCH (POUCH) in 1 CARTON
1NDC:55154-4853-61 TABLET (TABLET) in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02020401/11/1994
Labeler - Cardinal Health (188557102)
Establishment
NameAddressID/FEIOperations
Cardinal Health188557102REPACK

Revised: 05/2011
 
Cardinal Health

See also...

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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