ALEVE- naproxen sodium tablet 
Select Corporation

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Aleve®

Drug Facts

Active ingredient (in each caplet)

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


1
nonsteroidal anti-inflammatory drug

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:

  • 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 at 20 weeks or later in 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 caplet every 8 to 12 hours while symptoms last
  • for the first dose you may take 2 caplets within the first hour
  • do not exceed 2 caplets in any 8 to 12-hour period
  • do not exceed 3 caplets 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)

manufactured by Bayer.

PRINCIPAL DISPLAY PANEL - 220 mg Caplet Pouch Carton

ALL DAY STRONG®

ALEVE®

naproxen sodium tablets, 220 mg (NSAID)
Pain reliever/fever reducer

1 Caplet
Single-Pack
Capsule-Shaped Tablets

STRENGTH TO LAST 12 HOURS

PRINCIPAL DISPLAY PANEL - 220 mg Caplet Pouch Carton
ALEVE 
naproxen sodium tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52904-832(NDC:0280-6000)
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
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
FD&C blue no. 2 (UNII: L06K8R7DQK)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
microcrystalline cellulose (UNII: OP1R32D61U)  
talc (UNII: 7SEV7J4R1U)  
titanium dioxide (UNII: 15FIX9V2JP)  
Product Characteristics
ColorBLUEScoreno score
ShapeOVAL (capsule shaped tablets) Size12mm
FlavorImprint Code Aleve
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52904-832-031 in 1 BLISTER PACK02/26/2014
11 in 1 POUCH; Type 0: Not a Combination Product
2NDC:52904-832-042 in 1 BLISTER PACK02/26/2014
21 in 1 POUCH; Type 0: Not a Combination Product
3NDC:52904-832-2525 in 1 CARTON02/26/2014
31 in 1 POUCH; Type 0: Not a Combination Product
4NDC:52904-832-3030 in 1 CARTON02/26/2014
41 in 1 POUCH; Type 0: Not a Combination Product
5NDC:52904-832-5050 in 1 CARTON02/26/2014
51 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02020402/26/2014
Labeler - Select Corporation (053805599)

Revised: 6/2022
Document Id: 571f93d3-0ce8-4d7c-b191-e70329aeaf38
Set id: c95dceed-4968-486f-aecf-2942eda41a95
Version: 2
Effective Time: 20220607
 
Select Corporation