Indications and 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
Aleve
- Manufacturer
- Lil' Drug Store Products, Inc
- Effective date
- 2022-12-06
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-05-31 23:52:36
Label at a glance#
ProductAleve
Active ingredientNAPROXEN SODIUM
Label structure9 sections
Dosage and administration
Do not take more than directed. T he smallest effective dose should be used. D rink 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.
Storage and handling
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).
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient (in each caplet)
Naproxen sodium 220 mg (naproxen 200 mg) (NSAID) 1
1nonsteroidal anti-inflammatory drug
Purposes
Pain reliever/fever reducer
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
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
Do not use
- 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 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, 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 are
- under a doctor's care for any serious condition
- taking any other drug
When using this product
- 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 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
- 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 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.
Keep out of reach of children
In case of overdose, get medical help or contact a Poison Control Center right away.
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 exceed 3 caplets in a 24-hour period. Children under 12 years: ask a doctor.
Other informatin
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 ingredients
FD&C blue #2 lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, titanium dioxide
Questions or comments?
1-800-395-0689 (Mon-Fri 9AM-5PM EST)
Dist. by: Bayer Healthcare LLC
Whippany, NJ 07981
MADE IN MEXICO
Principal Display Panel
WHILE FOLDED ON LINE, TEAR OPEN AT DOT OR USE SCISSORS
DO NOT USE IF POUCH IS TORN OR OPEN
ALL DAY STRONG®
ALEVE
naproxen sodium tablets, 220 mg (NSAID)
Pain reliever/fever reducer
STRENGTH TO LAST 12 HOURS
1 CAPLET
CAPSULE-SHAPED TABLETS
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 849728 | Aleve 220 MG Oral Tablet | PSN | 2 |
| 849574 | naproxen sodium 220 MG Oral Tablet | PSN | 2 |
| 849728 | naproxen sodium 220 MG Oral Tablet [Aleve] | SBD | 2 |
| 849574 | naproxen sodium 220 MG Oral Tablet | SCD | 2 |
| 849728 | Aleve 220 MG Oral Tablet | SY | 2 |
| 849574 | naproxen sodium 220 MG (as naproxen 200 MG) Oral Tablet | SY | 2 |
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 |
|---|---|---|---|---|---|---|
| 66715-5103-0 | Aleve | 2 in 1 POUCH | TABLET | 2 | 2 | |
| 66715-5103-0 | Aleve | 30 in 1 BOX, UNIT-DOSE | TABLET | 30 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 66715-5103 | ALEVE (NAPROXEN SODIUM TABLET) TABLET [LIL' DRUG STORE PRODUCTS, INC] | 2 | Current NDC, Legacy NDC, 2 package rows | 20221223_d82586b5-c2ee-3f56-e053-2a95a90a42c4.zip |
Products#
Every source-derived product name is available through these pages.
- Aleve
- naproxen sodium tablet
- ALUMINUM OXIDE
- POVIDONE, UNSPECIFIED
- FD&C BLUE NO. 2
- HYPROMELLOSE, UNSPECIFIED
- MAGNESIUM STEARATE
- CELLULOSE, MICROCRYSTALLINE
- TALC
- TITANIUM DIOXIDE
- NAPROXEN SODIUM
- NAPROXEN
- POLYETHYLENE GLYCOL, UNSPECIFIED
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 66715-5103 | 66715-5103-0 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ALUMINUM OXIDE | LMI26O6933 | IACT |
| POVIDONE, UNSPECIFIED | FZ989GH94E | IACT |
| FD&C BLUE NO. 2 | L06K8R7DQK | IACT |
| HYPROMELLOSE, UNSPECIFIED | 3NXW29V3WO | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| TALC | 7SEV7J4R1U | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| NAPROXEN SODIUM | 9TN87S3A3C | ACTIB |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
Source Document#
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 |
|---|---|---|---|---|---|---|
| Aleve | NAPROXEN SODIUM TABLET | Lil' Drug Store Products, Inc | d82586b5-c2ee-3f56-e053-2a95a90a42c4 | 2022-12-06 | Warnings | 66715-5103-0 66715-5103 66715510300 ef307cfd-6227-37cc-e053-2995a90aeba8 d82586b5-c2ee-3f56-e053-2a95a90a42c4 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.