ALEVE CAPLETS - EASY OPEN ARTHRITIS CAP- naproxen sodium tablet 
Bayer HealthCare LLC.

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Aleve ®

Caplets - Easy Open Arthritis Cap

Drug Facts

Active ingredient (in each caplet)

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


1
nonsteroidal anti-inflammatory drug

Purposes

Pain reliever/fever reducer

Uses

temporarily relieves minor aches and pains due to:

● minor pain of arthritis

● muscular aches

● backache

● menstrual cramps

● headache

● toothache

● the common cold

● temporarily reduces fever

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 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, hypromelloses, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidones, 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 - 270 Caplet Bottle Carton

SOFT GRIP® ARTHRITIS CAP

ALL DAY STRONG ®

ALEVE ®

naproxen sodium tablets, 220 mg (NSAID)

Pain reliever/fever reducer

THIS PACKAGE IS CHILD RESISTANT

STRENGTH TO LAST 12 HOURS

270 CAPLETS

CAPSULE-SHAPED TABLETS

Carton label

ALEVE  CAPLETS - EASY OPEN ARTHRITIS CAP
naproxen sodium tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0280-6050
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. 2 (UNII: L06K8R7DQK)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
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:0280-6050-501 in 1 CARTON11/11/2013
150 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:0280-6050-01100 in 1 BOTTLE; Type 0: Not a Combination Product11/11/2013
3NDC:0280-6050-271 in 1 CARTON11/11/2013
3270 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:0280-6050-0224 in 1 BOTTLE; Type 0: Not a Combination Product06/11/2020
5NDC:0280-6050-031 in 1 CARTON11/11/2013
5130 in 1 BOTTLE; Type 0: Not a Combination Product
6NDC:0280-6050-041 in 1 CARTON11/11/2013
6150 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02020411/11/2013
Labeler - Bayer HealthCare LLC. (112117283)

Revised: 6/2020
Document Id: a7cf7126-74af-a0a0-e053-2a95a90a578a
Set id: 94f09ef7-0695-4499-83c1-95f1e42baf98
Version: 4
Effective Time: 20200611
 
Bayer HealthCare LLC.