Aleve liquid gels

Manufacturer
Bayer Healthcare LLC | Patheon Softgels Inc.
Effective date
2024-05-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:12:18

Label at a glance#

ProductAleve liquid gels
Active ingredientNAPROXEN SODIUM
Label structure28 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each capsule)

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

*nonsteroidal anti-inflammatory drug

OTC - PURPOSE SECTION

Purposes

Pain Reliever/Fever Reducer

INDICATIONS & USAGE SECTION

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 SECTION

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.

OTC - DO NOT USE SECTION

Do not use

  • if you have ever had an allergic reaction to any other pain reliever/fever reducer
  • right before or after heart surgery

OTC - ASK DOCTOR SECTION

Ask a doctor before use if

  • 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

OTC - ASK DOCTOR/PHARMACIST SECTION

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

OTC - WHEN USING SECTION

When using this product

  • take with food or milk if stomach upset occurs

OTC - STOP USE SECTION

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
  • slurred speech
  • weakness in one part or side of body
  • 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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

Directions

  • do not take more than directed
  • the smallest effective dose should be used
  • drink a full glass of water with each dose
  • if taken with food, this product may take longer to work
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 SAFETY INFORMATION

Other information

  • each capsule contains: sodium 20 mg
  • store at 20°-25°C (68°-77°F). Avoid high humidity and excessive heat above 40°C (104°F).
  • protect from light
  • read all directions and warnings before use.

INACTIVE INGREDIENT SECTION

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

OTC - QUESTIONS SECTION

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

PRINCIPAL DISPLAY PANEL - 160 Capsules Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Box Label
Box Label

PRINCIPAL DISPLAY PANEL - 20 Capsules Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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
Box Label

PRINCIPAL DISPLAY PANEL - 20 Capsules Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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
Box Label

PRINCIPAL DISPLAY PANEL - 50 Capsules Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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
Box Label

PRINCIPAL DISPLAY PANEL - 50 Capsules Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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
Box Label

PRINCIPAL DISPLAY PANEL - 80 Capsules Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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
Box Label

PRINCIPAL DISPLAY PANEL - 80 Capsules Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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
Box Label

PRINCIPAL DISPLAY PANEL - 80 Capsules Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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
Box Label

PRINCIPAL DISPLAY PANEL - 80 Capsules Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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
Box Label

PRINCIPAL DISPLAY PANEL - 120 Capsules Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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
Box Label

PRINCIPAL DISPLAY PANEL - 120 Capsules Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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
Box Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1112233Aleve 220 MG Oral CapsulePSN2
1112231naproxen sodium 220 MG Oral CapsulePSN2
1112233naproxen sodium 220 MG Oral Capsule [Aleve]SBD2
1112231naproxen sodium 220 MG Oral CapsuleSCD2
1112233Aleve 220 MG (naproxen 200 MG) Oral CapsuleSY2
1112233Aleve 220 MG Oral CapsuleSY2
1112231naproxen sodium 220 MG (as naproxen 200 MG) Oral CapsuleSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
NAPROXEN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20191108

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fef6ad89-235f-4274-ba49-a8e53642473eProduct name220250225
87fed3e6-8fba-48ef-96b0-3a7fb54b96ffProduct name320230306
b5fdaaec-7251-4da6-9cb2-4e9e76939ec8Product name120200623
e76dbbc1-775d-722c-08ff-ed45e8a80defProduct name320181002
6f4f4521-fd56-1ae6-888b-3b021bd75c7cProduct name120140508
ce67e27d-1d21-5465-4409-b0662dd99d4dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0280-0105-01Aleve liquid gels120 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED1202
0280-0105-02Aleve liquid gels160 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED1602
0280-0105-03Aleve liquid gels20 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED202
0280-0105-04Aleve liquid gels50 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED502
0280-0105-05Aleve liquid gels80 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED802
0280-0105-06Aleve liquid gels80 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED802

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0280-0105ALEVE LIQUID GELS (NAPROXEN SODIUM) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC]2Current NDC, 6 package rows20240510_a0587c73-d297-462d-a0ef-750cb324486e.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0280-01050280-0105-02, 0280-0105-03, 0280-0105-04, 0280-0105-05, 0280-0105-06, 0280-0105-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A214463-001NAPROXEN SODIUMNAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2023-01-10

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A214463-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2023-01-10c2088c7a36db…
2026-09-14 22:38:342026-08A214463-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2023-01-1084e616aacf4f…
2026-08-18 06:07:402026-07A214463-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2023-01-10caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A214463-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2023-01-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214463-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2023-01-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A214463-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2023-01-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214463-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2023-01-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214463-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2023-01-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214463-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2023-01-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214463-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2023-01-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214463-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2023-01-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214463-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2023-01-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214463-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2023-01-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214463-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2023-01-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214463-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2023-01-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214463-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2023-01-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05A214463-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2023-01-108072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A214463-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2023-01-106a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A214463-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2023-01-101c564ffb4f44…
2023-12-20 04:57 UTC2023-12A214463-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2023-01-10ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A214463-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2023-01-10a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A214463-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2023-01-109b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A214463-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2023-01-10a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A214463-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2023-01-103f0d92c62455…
2023-05-13 08:27 UTC2023-05A214463-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2023-01-10053a50430f4f…
2023-01-26 05:58 UTC2023-01A214463-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2023-01-103bdfa0b2c4d7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214463-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2023-01-10a50c72e98297…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aleve liquid gelsNAPROXEN SODIUMBayer Healthcare LLCa0587c73-d297-462d-a0ef-750cb324486e2024-05-06WarningsExact identifier
ndc (package): 0280-0105-06
ndc (package): 0280-0105-01
ndc (package): 0280-0105-04
ndc (package): 0280-0105-03
ndc (package): 0280-0105-05
ndc (package): 0280-0105-02
ndc (product): 0280-0105
ndc11 (package): 00280010505
ndc11 (package): 00280010503
ndc11 (package): 00280010502
ndc11 (package): 00280010504
ndc11 (package): 00280010506
ndc11 (package): 00280010501
spl id: 2766b060-5c1b-41fb-b8ca-cfb1a021b64e
spl set id: a0587c73-d297-462d-a0ef-750cb324486e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.