Aleve®

Aleve (Naproxen Sodium) Lil', tablet (220 mg)

Active Ingredient(s):

Naproxen Sodium

Country:

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Off On

PurposesCollapse

Pain reliever/fever reducer

UsesCollapse

  • 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

DirectionsCollapse

  • do not take more than directed
  • the smallest effective dose should be used
  • drink a full glass of water with each dose
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

WarningsCollapse

Allergy AlertCollapse

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 WarningCollapse

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

Do Not UseCollapse

  • 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 IfCollapse

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

Ask A Doctor Or Pharmacist Before Use If You AreCollapse

  • under a doctor's care for any serious condition
  • taking any other drug

When Using This ProductCollapse

  • take with food or milk if stomach upset occurs
  • the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

Stop Use And Ask A Doctor IfCollapse

  • 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
  • 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

OTC - Pregnancy Or Breast Feeding SectionCollapse

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.

OTC - Keep Out Of Reach Of Children SectionCollapse

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

Principal Display Panel - 3 Tablet Pouch CartonCollapse

See new warnings information

ALL DAY STRONG®
ALEVE®

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

STRENGTH TO LAST 12 HOURS

Bayer HealthCare

3 CAPLETS
CAPSULE-SHAPED TABLETS

Lil'
DrugStore
®

PRINCIPAL DISPLAY PANEL - 3 Tablet Pouch Carton
ALEVE 
naproxen sodium tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:66715-9702
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Naproxen Sodium (UNII: 9TN87S3A3C) (Naproxen - UNII: 57Y76R9ATQ) Naproxen Sodium 220 mg
Inactive Ingredients
Ingredient Name Strength
Aluminum Oxide (UNII: LMI26O6933)  
FD&C blue no. 2 (UNII: L06K8R7DQK)  
Hypromelloses (UNII: 3NXW29V3WO)  
Magnesium Stearate (UNII: 70097M6I30)  
Cellulose, Microcrystalline (UNII: OP1R32D61U)  
Polyethylene Glycols (UNII: 3WJQ0SDW1A)  
Povidones (UNII: FZ989GH94E)  
Talc (UNII: 7SEV7J4R1U)  
Titanium Dioxide (UNII: 15FIX9V2JP)  
Product Characteristics
Color BLUE Score no score
Shape OVAL Size 12mm
Flavor Imprint Code Aleve
Contains     
Packaging
# Item Code Package Description
1 NDC:66715-9702-1 1 in 1 CARTON
1 1 in 1 POUCH; Type 0: Not a Combination Product
2 NDC:66715-9702-2 2 in 1 CARTON
2 1 in 1 POUCH; Type 0: Not a Combination Product
3 NDC:66715-9702-3 3 in 1 CARTON
3 1 in 1 POUCH; Type 0: Not a Combination Product
4 NDC:66715-9702-0 30 in 1 CARTON
4 1 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information (Status: active)
Marketing Category Application Number or Monograph Citation Application Approval Date Marketing Start Date
NDA NDA020204 01/01/2000
Labeler - Lil' Drug Store Products, Inc (093103646)

Collapse All Sections Collapse

SPL Unclassified SectionCollapse

Drug Facts

Active Ingredient (in Each Caplet)Collapse

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


1
nonsteroidal anti-inflammatory drug

PurposesCollapse

Pain reliever/fever reducer

UsesCollapse

  • 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

WarningsCollapse

Allergy AlertCollapse

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 WarningCollapse

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

Do Not UseCollapse

  • 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 IfCollapse

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

Ask A Doctor Or Pharmacist Before Use If You AreCollapse

  • under a doctor's care for any serious condition
  • taking any other drug

When Using This ProductCollapse

  • take with food or milk if stomach upset occurs
  • the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

Stop Use And Ask A Doctor IfCollapse

  • 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
  • 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

OTC - Pregnancy Or Breast Feeding SectionCollapse

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.

OTC - Keep Out Of Reach Of Children SectionCollapse

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

DirectionsCollapse

  • do not take more than directed
  • the smallest effective dose should be used
  • drink a full glass of water with each dose
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 InformationCollapse

  • each caplet contains: sodium 20 mg
  • store at 20-25°C (68-77°F). Avoid high humidity and excessive heat above 40°C (104°F).

Inactive IngredientsCollapse

FD&C blue #2 lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, titanium dioxide

Questions Or Comments?Collapse

1-800-395-0689 (Mon-Fri 9AM-5PM EST) or www.aleve.com

SPL Unclassified SectionCollapse

manufactured by Bayer HealthCare LLC

Principal Display Panel - 3 Tablet Pouch CartonCollapse

See new warnings information

ALL DAY STRONG®
ALEVE®

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

STRENGTH TO LAST 12 HOURS

Bayer HealthCare

3 CAPLETS
CAPSULE-SHAPED TABLETS

Lil'
DrugStore
®

PRINCIPAL DISPLAY PANEL - 3 Tablet Pouch Carton
ALEVE 
naproxen sodium tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:66715-9702
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Naproxen Sodium (UNII: 9TN87S3A3C) (Naproxen - UNII: 57Y76R9ATQ) Naproxen Sodium 220 mg
Inactive Ingredients
Ingredient Name Strength
Aluminum Oxide (UNII: LMI26O6933)  
FD&C blue no. 2 (UNII: L06K8R7DQK)  
Hypromelloses (UNII: 3NXW29V3WO)  
Magnesium Stearate (UNII: 70097M6I30)  
Cellulose, Microcrystalline (UNII: OP1R32D61U)  
Polyethylene Glycols (UNII: 3WJQ0SDW1A)  
Povidones (UNII: FZ989GH94E)  
Talc (UNII: 7SEV7J4R1U)  
Titanium Dioxide (UNII: 15FIX9V2JP)  
Product Characteristics
Color BLUE Score no score
Shape OVAL Size 12mm
Flavor Imprint Code Aleve
Contains     
Packaging
# Item Code Package Description
1 NDC:66715-9702-1 1 in 1 CARTON
1 1 in 1 POUCH; Type 0: Not a Combination Product
2 NDC:66715-9702-2 2 in 1 CARTON
2 1 in 1 POUCH; Type 0: Not a Combination Product
3 NDC:66715-9702-3 3 in 1 CARTON
3 1 in 1 POUCH; Type 0: Not a Combination Product
4 NDC:66715-9702-0 30 in 1 CARTON
4 1 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information (Status: active)
Marketing Category Application Number or Monograph Citation Application Approval Date Marketing Start Date
NDA NDA020204 01/01/2000
Labeler - Lil' Drug Store Products, Inc (093103646)

Revised: 9/2014
 
Lil' Drug Store Products, Inc