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Aleve Gelcaps by Bayer HealthCare LLC.

Medically reviewed on July 19, 2017

Dosage form: tablet, coated
Ingredients: NAPROXEN SODIUM 220mg
Labeler: Bayer HealthCare LLC.
NDC Code: 0280-6020

Aleve ®

Gelcaps

Drug Facts

Active ingredient (in each tablet)

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
  • 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.

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 tablet every 8 to 12 hours while symptoms last
  • for the first dose you may take 2 tablets within the first hour
  • do not exceed 2 tablets in any 8- to 12-hour period
  • do not exceed 3 tablets in a 24-hour period
Children under 12 years
  • ask a doctor

Other information
  • each tablet contains: sodium 20 mg
  • store at room temperature. Avoid excessive heat above 40°C (104°F).

Inactive ingredients

D&C yellow #10 aluminum lake, edetate disodium, edible ink, FD&C blue #1, FD&C yellow #6 aluminum lake, gelatin, glycerin, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, stearic acid, talc, titanium dioxide

Questions or comments?

1-800-395-0689 (Mon-Fri 9AM – 5PM EST)

Dist. by:
Bayer HealthCare LLC
Whippany, NJ 07981

PRINCIPAL DISPLAY PANEL - 40 Gelcap Bottle Carton

ALL DAY STRONG ®

ALEVE®

naproxen sodium tablets, 220 mg (NSAID)

Pain reliever/fever reducer

STRENGTH TO LAST 12 HOURS

40 GELCAPS

GELATIN COATED

CAPSULE-SHAPED TABLETS

ALEVE  GELCAPS
naproxen sodium tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0280-6020
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NAPROXEN SODIUM (NAPROXEN) NAPROXEN SODIUM220 mg
Inactive Ingredients
Ingredient NameStrength
D&C YELLOW NO. 10 
ALUMINUM OXIDE 
EDETATE DISODIUM 
FD&C BLUE NO. 1 
FD&C YELLOW NO. 6 
GELATIN 
GLYCERIN 
HYPROMELLOSES 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
POVIDONES 
STEARIC ACID 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColoryellowScoreno score
ShapeOVALSize15mm
FlavorImprint CodeALEVE
Contains    
Packaging
#Item CodePackage Description
1NDC:0280-6020-201 BOTTLE in 1 CARTON
120 TABLET, COATED in 1 BOTTLE
2NDC:0280-6020-401 BOTTLE in 1 CARTON
240 TABLET, COATED in 1 BOTTLE
3NDC:0280-6020-801 BOTTLE in 1 CARTON
380 TABLET, COATED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02020408/01/2002
Labeler - Bayer HealthCare LLC. (112117283)

 
Bayer HealthCare LLC.

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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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