Bayer Aleve
- Manufacturer
- Unifirst First Aid Corporation | Bayer Healthcare LLC
- Effective date
- 2025-09-09
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 11
- Source
- full-release
- Hydrated at
- 2026-06-01 01:13:15
Label at a glance#
Contacts and useful links#
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 stomach ulcers or bleeding problems
take a blood thinner (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. 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 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
- 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 at 20 weeks or later in pregnancy unless specifically 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 accidental 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 21 mg
- store at 20-25ºC (68-77ºF). Avoid high humidity and excessive heat above 40ºC (104ºF)
Inactive ingredients
Colliodal silicon dioxide, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, mannitol, polyethylene glycol, sodium starch glycolate, stearic acid, titanium dioxide
Questions or comments?
1-800-395-0689 (Mon-Fri 9AM-5PM EST)
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
All Day Strong
Aleve
naproxen sodium tablets, 220 mg (NSAID)
Pain reliever/fever reducer
Pull To Open
Bayer
Strength To Last 12 Hours
50 Caplets
Capsule-Shaped Tablets, 1 /PKT
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 849728 | Aleve 220 MG Oral Tablet | PSN | 11 |
| 849574 | naproxen sodium 220 MG Oral Tablet | PSN | 11 |
| 849728 | naproxen sodium 220 MG Oral Tablet [Aleve] | SBD | 11 |
| 849574 | naproxen sodium 220 MG Oral Tablet | SCD | 11 |
| 849728 | Aleve 220 MG Oral Tablet | SY | 11 |
| 849574 | naproxen sodium 220 MG (as naproxen 200 MG) Oral Tablet | SY | 11 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| NAPROXEN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20191108 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| fef6ad89-235f-4274-ba49-a8e53642473e | Product name | 2 | 20250225 |
| 87fed3e6-8fba-48ef-96b0-3a7fb54b96ff | Product name | 3 | 20230306 |
| b5fdaaec-7251-4da6-9cb2-4e9e76939ec8 | Product name | 1 | 20200623 |
| e76dbbc1-775d-722c-08ff-ed45e8a80def | Product name | 3 | 20181002 |
| 6f4f4521-fd56-1ae6-888b-3b021bd75c7c | Product name | 1 | 20140508 |
| ce67e27d-1d21-5465-4409-b0662dd99d4d | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 47682-488-50 | Bayer Aleve | 1 in 1 POUCH | TABLET | 1 | 11 | |
| 47682-488-50 | Bayer Aleve | 50 in 1 BOX | TABLET | 50 | 11 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| NAPROXEN SODIUM | ACTIVE INGREDIENT | 9TN87S3A3C | 1 | |
| NAPROXEN | ACTIVE MOIETY | 57Y76R9ATQ | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | 1 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | 1 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 1 |
Products#
Every source-derived product name is available through these pages.
- Bayer Aleve
- Naproxen Sodium
- STEARIC ACID
- FD&C BLUE NO. 2
- HYPROMELLOSES
- MAGNESIUM STEARATE
- POLYETHYLENE GLYCOL, UNSPECIFIED
- TITANIUM DIOXIDE
- NAPROXEN
- SODIUM STARCH GLYCOLATE TYPE A CORN
- MANNITOL
- SILICON DIOXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 47682-488 | 47682-488-50 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| STEARIC ACID | 4ELV7Z65AP | IACT |
| FD&C BLUE NO. 2 | L06K8R7DQK | IACT |
| HYPROMELLOSES | 3NXW29V3WO | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| NAPROXEN SODIUM | 9TN87S3A3C | ACTIB |
| SODIUM STARCH GLYCOLATE TYPE A CORN | AG9B65PV6B | IACT |
| MANNITOL | 3OWL53L36A | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| POVIDONES | POVIDONE | FZ989GH94E | TABLET / ORAL | 216 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET / ORAL | 1127 mg | ||
| FD&C BLUE NO. 2 | FD&C BLUE NO. 2 | L06K8R7DQK | TABLET / ORAL | 25 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET / ORAL | 6184 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET / ORAL | 6184 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET / ORAL | 1000 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET / ORAL | 980 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET / ORAL | 1127 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET / ORAL | 980 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET / ORAL | 232 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | TABLET / ORAL | 216 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET / ORAL | 1000 mg | ||
| FD&C BLUE NO. 2 | FD&C BLUE NO. 2 | L06K8R7DQK | TABLET / ORAL | 25 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET / ORAL | 232 mg |
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N020204-002 | ALEVE | NAPROXEN SODIUM | 220MG | TABLET / ORAL | RLD, RS | 1994-01-11 |
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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N020204-002 | ALEVE | 220MG | TABLET / ORAL | RLD, RS | 1994-01-11 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N020204-002 | ALEVE | 220MG | TABLET / ORAL | RLD, RS | 1994-01-11 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020204-002 | ALEVE | 220MG | TABLET / ORAL | RLD, RS | 1994-01-11 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020204-002 | ALEVE | 220MG | TABLET / ORAL | RLD, RS | 1994-01-11 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020204-002 | ALEVE | 220MG | TABLET / ORAL | RLD, RS | 1994-01-11 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020204-002 | ALEVE | 220MG | TABLET / ORAL | RLD, RS | 1994-01-11 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020204-002 | ALEVE | 220MG | TABLET / ORAL | RLD, RS | 1994-01-11 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020204-002 | ALEVE | 220MG | TABLET / ORAL | RLD, RS | 1994-01-11 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020204-002 | ALEVE | 220MG | TABLET / ORAL | RLD, RS | 1994-01-11 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020204-002 | ALEVE | 220MG | TABLET / ORAL | RLD, RS | 1994-01-11 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020204-002 | ALEVE | 220MG | TABLET / ORAL | RLD, RS | 1994-01-11 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N020204-002 | ALEVE | 220MG | TABLET / ORAL | RLD, RS | 1994-01-11 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020204-002 | ALEVE | 220MG | TABLET / ORAL | RLD, RS | 1994-01-11 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020204-002 | ALEVE | 220MG | TABLET / ORAL | RLD, RS | 1994-01-11 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020204-002 | ALEVE | 220MG | TABLET / ORAL | RLD, RS | 1994-01-11 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N020204-002 | ALEVE | 220MG | TABLET / ORAL | RLD, RS | 1994-01-11 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020204-002 | ALEVE | 220MG | TABLET / ORAL | RLD, RS | 1994-01-11 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N020204-002 | ALEVE | 220MG | TABLET / ORAL | RLD, RS | 1994-01-11 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N020204-002 | ALEVE | 220MG | TABLET / ORAL | RLD, RS | 1994-01-11 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N020204-002 | ALEVE | 220MG | TABLET / ORAL | RLD, RS | 1994-01-11 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N020204-002 | ALEVE | 220MG | TABLET / ORAL | RLD, RS | 1994-01-11 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N020204-002 | ALEVE | 220MG | TABLET / ORAL | RLD, RS | 1994-01-11 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N020204-002 | ALEVE | 220MG | TABLET / ORAL | RLD, RS | 1994-01-11 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N020204-002 | ALEVE | 220MG | TABLET / ORAL | RLD, RS | 1994-01-11 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N020204-002 | ALEVE | 220MG | TABLET / ORAL | RLD, RS | 1994-01-11 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N020204-002 | ALEVE | 220MG | TABLET / ORAL | RLD, RS | 1994-01-11 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N020204-002 | ALEVE | 220MG | TABLET / ORAL | RLD, RS | 1994-01-11 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N020204-002 | ALEVE | EQ 200MG BASE | TABLET / ORAL | RLD, RS | 1994-01-11 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | N020204-002 | ALEVE | EQ 200MG BASE | TABLET / ORAL | RLD, RS | 1994-01-11 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N020204-002 | ALEVE | 220MG | TABLET / ORAL | RLD, RS | 1994-01-11 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N020204-002 | ALEVE | 220MG | TABLET / ORAL | RLD, RS | 1994-01-11 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N020204-002 | ALEVE | 220MG | TABLET / ORAL | RLD, RS | 1994-01-11 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N020204-002 | ALEVE | 220MG | TABLET / ORAL | RLD, RS | 1994-01-11 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N020204-002 | ALEVE | 220MG | TABLET / ORAL | RLD, RS | 1994-01-11 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N020204-002 | ALEVE | 220MG | TABLET / ORAL | RLD, RS | 1994-01-11 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N020204-002 | ALEVE | 220MG | TABLET / ORAL | RLD, RS | 1994-01-11 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N020204-002 | ALEVE | 220MG | TABLET / ORAL | RLD, RS | 1994-01-11 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N020204-002 | ALEVE | 220MG | TABLET / ORAL | RLD, RS | 1994-01-11 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N020204-002 | ALEVE | 220MG | TABLET / ORAL | RLD, RS | 1994-01-11 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | N020204-002 | ALEVE | 220MG | TABLET / ORAL | RLD, RS | 1994-01-11 | f41ea6bd6efb… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Bayer Aleve | NAPROXEN SODIUM | Unifirst First Aid Corporation | 5dd569ca-d03e-410c-af98-4732c823d595 | 2025-09-09 | Warnings | 47682-488-50 47682-488 47682048850 3e5d43d6-74c5-08f6-e063-6394a90a0a54 5dd569ca-d03e-410c-af98-4732c823d595 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
