ALEVE LIQUID GELS- naproxen sodium capsule, liquid filled 
Bayer Healthcare LLC

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ALEVE LIQUID GELS

Drug Facts

Active ingredient (in each capsule)

Naproxen Sodium 220mg (Naproxen 200mg) (NSAID)*

*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:

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:

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

Ask a doctor before use if

Ask a doctor or pharmacist before use if you are

When using this product

Stop use and ask a doctor if

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 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
  • ask a doctor

Other information

Inactive ingredients ammonium hydroxide, FD&C blue #1, gelatin, glycerin, lactic acid, mannitol, polyethylene glycol, polyvinyl acetate phthalate, povidone, propylene glycol, purified water, sorbitan-sorbitol solution, titanium dioxide

Questions or comments? 1-800-395-0689
(Mon-Fri 9AM – 5PM EST)

PRINCIPAL DISPLAY PANEL - 160 Capsules Label

ALL DAY STRONG®

ALEVE®

LIQUID GELS

Naproxen Sodium Capsules, 200 mg (NSAID)
Pain Reliever/Fever Reducer

ALEVE

BAYER
STRENGTH TO
LAST 12 HOURS

160CAPSULES
LIQUID FILLED CAPSULES

Box Label

Box Label

PRINCIPAL DISPLAY PANEL - 20 Capsules Label

ALL DAY STRONG®

ALEVE®

LIQUID GELS

naproxen sodium capsules, 220 mg (NSAID)
Pain Reliever/Fever Reducer

BAYER

ALEVE

STRENGTH TO
LAST 12 HOURS

20CAPSULES
(LIQUID FILLED CAPSULES)

Box Label

PRINCIPAL DISPLAY PANEL - 20 Capsules Carton

ALL DAY STRONG®

ALEVE®

LIQUID GELS

Naproxen Sodium Capsules, 220 mg (NSAID)
Pain Reliever/Fever Reducer

BAYER

ALEVE
ACTUAL SIZE

STRENGTH
TO LAST
12 HOURS

20
CAPSULES
(LIQUID FILLED CAPSULES)

Box Label

PRINCIPAL DISPLAY PANEL - 50 Capsules Label

ALL DAY STRONG®

ALEVE®

LIQUID GELS

naproxen sodium capsules, 220 mg (NSAID)
Pain Reliever/Fever Reducer

BAYER

ALEVE

STRENGTH TO
LAST 12 HOURS

50CAPSULES
(LIQUID FILLED CAPSULES)

Box Label

PRINCIPAL DISPLAY PANEL - 50 Capsules Carton

ALL DAY STRONG®

ALEVE®

LIQUID GELS

Naproxen Sodium Capsules, 220 mg (NSAID)
Pain Reliever/Fever Reducer

BAYER

ALEVE
ACTUAL SIZE

STRENGTH
TO LAST
12 HOURS

50
CAPSULES
(LIQUID FILLED CAPSULES)

Box Label

PRINCIPAL DISPLAY PANEL - 80 Capsules Label

ALL DAY STRONG®

ALEVE®

LIQUID GELS

naproxen sodium capsules, 220 mg (NSAID)
Pain Reliever/Fever Reducer

BAYER

ALEVE

STRENGTH TO
LAST 12 HOURS

80CAPSULES
(LIQUID FILLED CAPSULES)

Box Label

PRINCIPAL DISPLAY PANEL - 80 Capsules Carton

ALL DAY STRONG®

ALEVE®

LIQUID GELS

Naproxen Sodium Capsules, 220 mg (NSAID)
Pain Reliever/Fever Reducer

BAYER

ALEVE
ACTUAL SIZE

STRENGTH
TO LAST
12 HOURS

80
CAPSULES
(LIQUID FILLED CAPSULES)

Box Label

PRINCIPAL DISPLAY PANEL - 80 Capsules Label

EASY OPEN
ARTHRITIS CAP

ALL DAY STRONG®

ALEVE®

LIQUID GELS

naproxen sodium capsules, 220 mg (NSAID)
Pain Reliever/Fever Reducer

THIS PACKAGE FOR HOUSEHOLDS
WITHOUT YOUNG CHILDREN

ALEVE

BAYER

STRENGTH TO
LAST 12 HOURS

80CAPSULES
(LIQUID FILLED CAPSULES)

Box Label

PRINCIPAL DISPLAY PANEL - 80 Capsules Carton

EASY OPEN ARTHRITIS CAP

ALL DAY STRONG®

ALEVE®

LIQUID GELS

Naproxen Sodium Capsules, 220 mg (NSAID)
Pain Reliever/Fever Reducer

THIS PACKAGE FOR
HOUSEHOLDS WITHOUT
YOUNG CHILDREN

BAYER

ALEVE
ACTUAL SIZE

STRENGTH
TO LAST
12 HOURS

80
CAPSULES
(LIQUID FILLED CAPSULES)

Box Label

PRINCIPAL DISPLAY PANEL - 120 Capsules Label

ALL DAY STRONG®

ALEVE®

LIQUID GELS

naproxen sodium capsules, 220 mg (NSAID)
Pain Reliever/Fever Reducer

BAYER

ALEVE

STRENGTH TO
LAST 12 HOURS

120CAPSULES
(LIQUID FILLED CAPSULES)

Box Label

PRINCIPAL DISPLAY PANEL - 120 Capsules Carton

120
LIQUID FILLED CAPSULES

ALL DAY STRONG®

ALEVE®

LIQUID GELS

Naproxen Sodium Capsules, 220 mg (NSAID)
Pain Reliever/Fever Reducer

BAYER

ALEVE
ACTUAL SIZE

STRENGTH
TO LAST
12 HOURS

120
CAPSULES
(LIQUID FILLED CAPSULES)

Box Label
ALEVE LIQUID GELS 
naproxen sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0280-0105
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
AMMONIA (UNII: 5138Q19F1X)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)  
MANNITOL (UNII: 3OWL53L36A)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SORBITAN (UNII: 6O92ICV9RU)  
SORBITOL (UNII: 506T60A25R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Colorblue (Blue with white text) Scoreno score
ShapeCAPSULESize25mm
FlavorImprint Code P797
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0280-0105-02160 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/01/2023
2NDC:0280-0105-0320 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/07/2024
3NDC:0280-0105-0450 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/14/2024
4NDC:0280-0105-0580 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/21/2024
5NDC:0280-0105-0680 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/17/2024
6NDC:0280-0105-01120 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/28/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21446312/01/2023
Labeler - Bayer Healthcare LLC (112117283)
Registrant - Bayer Healthcare LLC (072827066)
Establishment
NameAddressID/FEIBusiness Operations
Patheon Softgels Inc.002193829manufacture(0280-0105)

Revised: 5/2024
Document Id: 2766b060-5c1b-41fb-b8ca-cfb1a021b64e
Set id: a0587c73-d297-462d-a0ef-750cb324486e
Version: 2
Effective Time: 20240506
 
Bayer Healthcare LLC