ALEVE- naproxen sodium tablet 
Bayer HealthCare LLC.

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Aleve ® Tablets UI 1600169

Drug Facts

Active ingredient (in each tablet)

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


1
nonsteroidal anti-inflammatory drug

Purposes

Pain reliever/fever reducer

Uses

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

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

  • 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, kidney disease, asthma, or had a stroke
  • you are taking a diuretic
  • you have problems or serious side effects from taking pain relievers or fever reducers

Ask a doctor or pharmacist before use if you are

  • under a doctor's care for any serious condition
  • taking aspirin for heart attack or stroke, because naproxen may decrease this benefit of aspirin
  • taking any other drug

When using this product

  • take with food or milk if stomach upset occurs

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

  • you have symptoms of heart problems or stroke:
    • chest pain
    • trouble breathing
    • weakness in one part or side of body
    • slurred speech
    • leg swelling

  • 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

  • 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

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

PRINCIPAL DISPLAY PANEL - 24 Tablet Bottle Carton

ALL DAY STRONG®

ALEVE®

naproxen sodium tablets, 220 mg (NSAID)

Pain reliever/fever reducer

STRENGTH TO LAST 12 HOURS

ACTUAL SIZE
24 TABLETS

Aleve carton

ALEVE 
naproxen sodium tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0280-6010
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
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
Product Characteristics
Colorblue (light blue) Scoreno score
ShapeROUNDSize8mm
FlavorImprint Code ALEVE
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0280-6010-081 in 1 CARTON07/26/200201/30/2014
18 in 1 VIAL; Type 0: Not a Combination Product
2NDC:0280-6010-101 in 1 CARTON07/26/2002
210 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:0280-6010-241 in 1 CARTON07/26/2002
324 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:0280-6010-501 in 1 CARTON07/26/2002
450 in 1 BOTTLE; Type 0: Not a Combination Product
5NDC:0280-6010-011 in 1 CARTON07/26/2002
5100 in 1 BOTTLE; Type 0: Not a Combination Product
6NDC:0280-6010-021 in 1 CARTON07/26/2002
6130 in 1 BOTTLE; Type 0: Not a Combination Product
7NDC:0280-6010-031 in 1 CARTON07/26/2002
7150 in 1 BOTTLE; Type 0: Not a Combination Product
8NDC:0280-6010-041 in 1 CARTON07/26/2002
836 in 1 BOTTLE; Type 0: Not a Combination Product
9NDC:0280-6010-06225 in 1 BOTTLE; Type 0: Not a Combination Product07/26/2002
10NDC:0280-6010-051 in 1 CARTON07/26/2002
1065 in 1 BOTTLE; Type 0: Not a Combination Product
11NDC:0280-6010-07270 in 1 BOTTLE; Type 0: Not a Combination Product07/26/2002
12NDC:0280-6010-0990 in 1 BOTTLE; Type 0: Not a Combination Product07/26/2002
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02020407/26/2002
Labeler - Bayer HealthCare LLC. (112117283)

Revised: 7/2021
Document Id: c628f11e-95e1-876b-e053-2a95a90aaa1a
Set id: 00ef5b30-71d0-4cb4-84a3-48c67d1cea2a
Version: 15
Effective Time: 20210702
 
Bayer HealthCare LLC.