ALEVE BACK AND MUSCLE PAIN- naproxen sodium tablet 
Bayer HealthCare LLC.

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Aleve Back & Muscle Pain UI 1600169

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

Directions

Adults and children 12 years and older
  • take 1 tablets 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 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)

Dist. by :

Bayer Healthcare LLC

Whippany, NJ 07981

In case of overdose, get medical help or contact a Poison Control Center right away.

Package label display

Aleve Back and Muscle Pain - 24 Count Carton All Day Strong®

Aleve®

Back & Muscle Pain

naproxen sodium tablets, 220 mg (NSAID)

Pain reliever/fever reducer

Bayer

For temporary relief of minor back and muschle aches and pains

ACTUAL SIZE

Strength to Last 12 Hours 24Tablets

ALEVE BACK AND MUSCLE PAIN 
naproxen sodium tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0280-6092
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
MAGNESIUM STEARATE (UNII: 70097M6I30)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
POVIDONE (UNII: FZ989GH94E)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
Product Characteristics
ColorblueScoreno score
ShapeROUNDSize8mm
FlavorImprint Code ALEVE
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0280-6092-241 in 1 CARTON01/26/2018
124 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:0280-6092-501 in 1 CARTON01/26/2018
250 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3NDC:0280-6092-101 in 1 CARTON01/26/201809/30/2023
3100 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:0280-6092-251 in 1 CARTON08/06/2019
4250 in 1 BOTTLE; Type 0: Not a Combination Product
5NDC:0280-6092-021 in 1 CARTON01/26/2018
5130 in 1 BOTTLE; Type 0: Not a Combination Product
6NDC:0280-6092-041 in 1 CARTON01/26/2018
6200 in 1 BOTTLE; Type 0: Not a Combination Product
7NDC:0280-6092-051 in 1 CARTON01/26/2018
7225 in 1 BOTTLE; Type 0: Not a Combination Product
8NDC:0280-6092-061 in 1 CARTON01/26/201803/31/2022
836 in 1 BOTTLE; Type 0: Not a Combination Product
9NDC:0280-6092-071 in 1 CARTON01/26/201811/30/2021
965 in 1 BOTTLE; Type 0: Not a Combination Product
10NDC:0280-6092-081 in 1 CARTON07/01/2021
10250 in 1 BOTTLE; Type 0: Not a Combination Product
11NDC:0280-6092-091 in 1 CARTON07/01/2021
1190 in 1 BOTTLE; Type 0: Not a Combination Product
12NDC:0280-6092-1210 in 1 VIAL; Type 0: Not a Combination Product07/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02020401/26/2018
Labeler - Bayer HealthCare LLC. (112117283)

Revised: 9/2022
Document Id: e9325493-7c3f-e9f2-e053-2995a90a89b6
Set id: 6376e1b8-52c4-0519-e053-2a91aa0af35f
Version: 18
Effective Time: 20220921
 
Bayer HealthCare LLC.