ALEVE- naproxen sodium capsule, liquid filled 
Bayer HealthCare LLC.

----------

ALEVE ®

LIQUID GELS

Drug Facts

Active ingredient (in each capsule)

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
  • redness or swelling is present in the painful area
  • any new symptoms appear
  • you have difficulty swallowing
  • it feels like the capsule is stuck in your throat

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 capsule every 8 to 12 hours while symptoms last
  • for the first dose you may take 2 capsules within the first hour
  • do not exceed 2 capsules in any 8- to 12-hour period
  • do not exceed 3 capsules in a 24-hour period
Children under 12 years of age

  • ask a doctor

Other information

● each capsule contains: sodium 20 mg

● store at 20-25ºC (68-77ºF). Avoid high humidity and excessive heat above 40°C (104°F).

● read all directions and warnings before use. Keep carton

Inactive ingredients

FD&C blue #1, gelatin, glycerin, lactic acid, mannitol, pharmaceutical ink, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol

Questions or comments?

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

Distributed by:

Bayer Healthcare LLC
Whippany, NJ 07981

PRINCIPAL DISPLAY PANEL - 80 Capsule Bottle Carton

ALL DAY STRONG®

ALEVE®
LIQUID GELS

naproxen sodium capsules, 220 mg (NSAID)

pain reliever/fever reducer

Bayer HealthCare


STRENGTH TO LAST 12 HOURS


80 CAPSULES

(LIQUID-FILLED CAPSULES)

Carton 80 count

ALEVE 
naproxen sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0280-6080
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
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
LACTIC ACID (UNII: 33X04XA5AT)  
MANNITOL (UNII: 3OWL53L36A)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE K30 (UNII: U725QWY32X)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SORBITAN (UNII: 6O92ICV9RU)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
Colorblue (Blue with white text) Scoreno score
ShapeCAPSULESize25mm
FlavorImprint Code ALEVE
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0280-6080-201 in 1 CARTON02/20/2007
120 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:0280-6080-401 in 1 CARTON02/20/2007
240 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3NDC:0280-6080-801 in 1 CARTON02/20/2007
380 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
4NDC:0280-6080-16160 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/20/2007
5NDC:0280-6080-011 in 1 CARTON02/20/2007
5120 in 1 BOTTLE; Type 0: Not a Combination Product
6NDC:0280-6080-022 in 1 PACKAGE, COMBINATION02/20/2007
680 in 1 BOTTLE; Type 0: Not a Combination Product
7NDC:0280-6080-0352 in 1 BOTTLE; Type 0: Not a Combination Product02/20/200706/29/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02192002/20/2007
Labeler - Bayer HealthCare LLC. (112117283)

Revised: 4/2021
Document Id: c00583ec-1b86-5f12-e053-2a95a90a5c82
Set id: 1266393e-b55e-4e34-9710-0b87209f4158
Version: 11
Effective Time: 20210415
 
Bayer HealthCare LLC.