Aleve Easy Open Arthritis Cap

Dosage form: capsule, liquid filled
Ingredients: Naproxen Sodium 220mg
Labeler: Bayer HealthCare LLC, Consumer Care
NDC Code: 0280-6091

ALEVE®
LIQUID GELS

Drug Facts

Active ingredient (in each capsule)

Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)


nonsteroidal anti-inflammatory drug

Purposes

Pain reliever/fever reducer

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
  • 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 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 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
  • redness or swelling is present in the painful area
  • any new symptoms appear
  • you have difficulty swallowing
  • it feels like the capsule is stuck in your throat

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.

Directions
  • do not take more than directed
  • the smallest effective dose should be used
  • drink a full glass of water with each dose
  • if taken with food, this product may take longer to work
adults and children 12 years and older:
  • take 1 capsule every 8 to 12 hours while symptoms last
  • for the first dose you may take 2 capsules within the first hour
  • do not exceed 2 capsules in any 8- to 12-hour period
  • do not exceed 3 capsules in a 24-hour period
children under 12 years:
  • ask a doctor

Other information
  • each capsule contains: sodium 20 mg
  • store at 20-25°C (68-77°F) avoid high humidity and excessive heat above 40°C (104°F)
  • read all directions and warnings before use. Keep carton.

Inactive ingredients

FD&C blue #1, gelatin, glycerin, lactic acid, mannitol, pharmaceutical ink, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol

Questions or comments?

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

Distributed by:
Bayer HealthCare LLC
Consumer Care
P.O. Box 1910
Morristown, NJ 07962-1910 USA

PRINCIPAL DISPLAY PANEL - 80 Liquid Gel Carton

See new warnings information
ALEVE
®
LIQUID GELS

naproxen sodium capsules, 220 mg (NSAID)
pain reliever/fever reducer

EASY
OPEN
ARTHRITIS CAP

THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

Ease-of-Use
Commendation

For Packaging
ARTHRITIS
FOUNDATION®
www.arthritis.org

ALL DAY STRONG®
• 12 HOURS STRONG •

80
LIQUID GELS

(LIQUID FILLED CAPSULES)

ALEVE   EASY OPEN ARTHRITIS CAP
naproxen sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0280-6091
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. 1 
gelatin 
glycerin 
lactic acid 
mannitol 
polyethylene glycol 400 
povidone K30 
propylene glycol 
water 
sorbitan 
sorbitol 
Product Characteristics
ColorBLUE (Blue with white text) Scoreno score
ShapeCAPSULESize21mm
FlavorImprint CodeALEVE
Contains    
Packaging
#Item CodePackage Description
1NDC:0280-6091-801 BOTTLE, PLASTIC (BOTTLE) in 1 CARTON
180 CAPSULE, LIQUID FILLED (CAPSULE) in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02192002/28/2007
Labeler - Bayer HealthCare LLC, Consumer Care (785159372)

Revised: 09/2011
 
Bayer HealthCare LLC, Consumer Care

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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