Bayer Aleve

Manufacturer
Acme United Corporation
Effective date
2023-03-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:54:33

Label at a glance#

ProductBayer Aleve
Active ingredientNAPROXEN SODIUM
Label structure17 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each caplet)

Naproxen Sodium 220 mg (naproxen 200 mg) (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: NSAID,s except aspirin, increase the risk of heart attack, heart failure and stroke. These can be fatal. This risk is higher if you use more than directed or for longer than directed.

OTC - DO NOT USE SECTION

Do not use

  • if you ever have 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

  • 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

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
  • weakness in one part or side of body
  • slurred speech
  • leg swelling
  • pain gets worse or lasts for more than 10 days
  • fever gets worse or lasts for 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 SECTION

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 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

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 exceedc3 caplets in a 24- hour period.

Children under 12 years:

ask a doctor

OTHER SAFETY INFORMATION

Other information

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Box Label Box LabelBox Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
849728Aleve 220 MG Oral TabletPSN1
849574naproxen sodium 220 MG Oral TabletPSN1
849728naproxen sodium 220 MG Oral Tablet [Aleve]SBD1
849574naproxen sodium 220 MG Oral TabletSCD1
849728Aleve 220 MG Oral TabletSY1
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSY1

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
0924-6000-00Bayer Aleve1 in 1 POUCHTABLET11
0924-6000-01Bayer Aleve50 in 1 BOXTABLET501
0924-6000-01Bayer Aleve1 in 1 POUCHTABLET11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0924-6000BAYER ALEVE (NAPROXEN SODIUM) TABLET [ACME UNITED CORPORATION]1Current NDC, 3 package rows20230324_f758201c-28b8-5357-e053-6394a90a1e5d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0280-6000-10EA - Each0280-60003d7e705c-0aa1-49a0-b403-7f22091eab5412022-02-07
0280-6000-24EA - Each0280-6000b221ea71-b2e4-474c-a035-30da3e9e65e512021-07-15
0280-6000-32EA - Each0280-6000d95d3b04-0998-4a1e-8379-c0a2c5ac0cd212014-09-03
0280-6000-50EA - Each0280-6000e24c97ad-b92b-4c49-a641-af94b290daa012023-07-06

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0924-60000924-6000-01, 0924-6000-00
0280-6000

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 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 43.

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
N020204-002ALEVENAPROXEN SODIUM220MGTABLET / ORALRLD, RS1994-01-11

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.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-1184e616aacf4f…
2026-08-18 06:07:402026-07N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-111e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-114b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-1174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-11bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-11782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-1187673890dc5c…
2021-03-12 10:30 UTC2021-03N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-115aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-118869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-11c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-113f01610625f2…
2019-09-15 20:21 UTC2019-09N020204-002ALEVEEQ 200MG BASETABLET / ORALRLD, RS1994-01-11b00525d2431f…
2019-07-19 19:46 UTC2019-07N020204-002ALEVEEQ 200MG BASETABLET / ORALRLD, RS1994-01-11ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-116a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-111c564ffb4f44…
2023-12-20 04:57 UTC2023-12N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-11ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-11a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-119b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-11a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-113f0d92c62455…
2023-05-13 08:27 UTC2023-05N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-11053a50430f4f…
2023-01-26 05:58 UTC2023-01N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-113bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-113a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N020204-002ALEVE220MGTABLET / ORALRLD, RS1994-01-11f41ea6bd6efb…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aleve CapletsNAPROXEN SODIUMBayer HealthCare LLC.a3745850-3e32-4884-b315-161bcb9996ed2025-12-04Exact identifier
ndc (product): 0280-6000
Bayer AleveNAPROXEN SODIUMAcme United Corporationf758201c-28b8-5357-e053-6394a90a1e5d2023-03-20WarningsExact identifier
ndc (package): 0924-6000-00
ndc (package): 0924-6000-01
ndc (product): 0924-6000
ndc11 (package): 00924600000
ndc11 (package): 00924600001
spl id: f7582032-efbd-5f5b-e053-6394a90a994e
spl set id: f758201c-28b8-5357-e053-6394a90a1e5d

Reported adverse events (FAERS/openFDA)#

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