ALEVE GELCAPS- naproxen sodium tablet, coated 
Bayer HealthCare LLC.

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Aleve ®

Gelcaps

Drug Facts

Active ingredient (in each tablet)

Naproxen sodium 220 mg (naproxen 200 mg) (NSAID) 1


1
nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Uses

Directions

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

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

Aleve Gelcaps -  40 Count CartonSOFT GRIP® ARTHRITIS CAP

ALL DAY STRONG®

ALEVE®

naproxen sodium tablets, 220 mg (NSAID)

Pain reliever/fever reducer

THIS PACKAGE IS

CHILD-RESISTANT

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:0280-6070
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ) NAPROXEN SODIUM220 mg
Inactive Ingredients
Ingredient NameStrength
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColoryellowScoreno score
ShapeOVALSize15mm
FlavorImprint Code ALEVE
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0280-6070-401 in 1 CARTON08/01/2002
140 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02020408/01/2002
Labeler - Bayer HealthCare LLC. (112117283)

Revised: 9/2022
Document Id: e935e90c-5283-8757-e053-2995a90a5d2f
Set id: acea54a2-5a92-428e-a778-bb4f9d676782
Version: 12
Effective Time: 20220921
 
Bayer HealthCare LLC.