ALEVE HEADACHE PAIN- naproxen sodium tablet 
Bayer HealthCare LLC

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Aleve ® Headache Pain

Active Ingredient

Naproxen Sodium 220mg

Purposes:

Pain reliever/fever reducer

Uses:

Warnings:

Allergy Alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

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:

Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.

Do Not Use:

Ask a Doctor:

Ask a doctor or pharmacist before use

When using this product

Stop use and ask a doctor

The pregnancy/breast-feeding warning:

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:

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

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 ingredient

FD&C BLUE #2 LAKE, HYPROMELLOSE, MAGNESIUM STEARATE, MICROCRYSTALLINE CELLULOSE, POLYETHYLENE GLYCOL, POVIDONE, TALC, TITANIUM DIOXIDE

Questions & comments:

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

Dist. by :

Bayer Healthcare LLC

Whippany, NJ 07981

ALL DAY STRONG®

ALEVE

HEADACHE PAIN

naproxen sodium tablets, 220 mg (NSAID)

Pain reliever/fever reducer

Bayer

For temporary relief of headache pain

ACTUAL SIZE

STRENGTH TO LAST 12 HOURS

TABLETS

Aleve Headache Carton

ALEVE HEADACHE PAIN 
naproxen sodium tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0280-0041
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
2-NAPHTHALENEACETIC ACID, 6-METHOXY-.ALPHA.-METHYL-, SODIUM SALT, (S)- (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ) 2-NAPHTHALENEACETIC ACID, 6-METHOXY-.ALPHA.-METHYL-, SODIUM SALT, (S)-220 mg
Inactive Ingredients
Ingredient NameStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
TALC (UNII: 7SEV7J4R1U)  
Product Characteristics
ColorblueScoreno score
ShapeROUNDSize8mm
FlavorImprint Code ALEVE
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0280-0041-011 in 1 CARTON06/01/2021
1175 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:0280-0041-021 in 1 CARTON06/01/2021
250 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:0280-0041-041 in 1 CARTON06/01/2021
324 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:0280-0041-031 in 1 CARTON06/01/2021
490 in 1 BOTTLE; Type 0: Not a Combination Product
5NDC:0280-0041-051 in 1 POUCH; Type 0: Not a Combination Product06/01/2021
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02020406/01/2021
Labeler - Bayer HealthCare LLC (112117283)

Revised: 6/2021
Document Id: c69f60de-330e-1b91-e053-2a95a90ac13c
Set id: c69f4926-c5cd-63a0-e053-2a95a90a2ca6
Version: 1
Effective Time: 20210601
 
Bayer HealthCare LLC