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#
Contacts and useful links#
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 |
|
| Children under 12 years |
|
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
PRINCIPAL DISPLAY PANEL - 20 Capsules Label
PRINCIPAL DISPLAY PANEL - 20 Capsules Carton
PRINCIPAL DISPLAY PANEL - 50 Capsules Label
PRINCIPAL DISPLAY PANEL - 50 Capsules Carton
PRINCIPAL DISPLAY PANEL - 80 Capsules Label
PRINCIPAL DISPLAY PANEL - 80 Capsules Carton
PRINCIPAL DISPLAY PANEL - 80 Capsules Label
PRINCIPAL DISPLAY PANEL - 80 Capsules Carton
PRINCIPAL DISPLAY PANEL - 120 Capsules Label
PRINCIPAL DISPLAY PANEL - 120 Capsules Carton
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1112233 | Aleve 220 MG Oral Capsule | PSN | 2 |
| 1112231 | naproxen sodium 220 MG Oral Capsule | PSN | 2 |
| 1112233 | naproxen sodium 220 MG Oral Capsule [Aleve] | SBD | 2 |
| 1112231 | naproxen sodium 220 MG Oral Capsule | SCD | 2 |
| 1112233 | Aleve 220 MG (naproxen 200 MG) Oral Capsule | SY | 2 |
| 1112233 | Aleve 220 MG Oral Capsule | SY | 2 |
| 1112231 | naproxen sodium 220 MG (as naproxen 200 MG) Oral Capsule | 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 |
|---|---|---|---|---|---|---|
| 0280-0105-01 | Aleve liquid gels | 120 in 1 BOTTLE, PLASTIC | CAPSULE, LIQUID FILLED | 120 | 2 | |
| 0280-0105-02 | Aleve liquid gels | 160 in 1 BOTTLE, PLASTIC | CAPSULE, LIQUID FILLED | 160 | 2 | |
| 0280-0105-03 | Aleve liquid gels | 20 in 1 BOTTLE, PLASTIC | CAPSULE, LIQUID FILLED | 20 | 2 | |
| 0280-0105-04 | Aleve liquid gels | 50 in 1 BOTTLE, PLASTIC | CAPSULE, LIQUID FILLED | 50 | 2 | |
| 0280-0105-05 | Aleve liquid gels | 80 in 1 BOTTLE, PLASTIC | CAPSULE, LIQUID FILLED | 80 | 2 | |
| 0280-0105-06 | Aleve liquid gels | 80 in 1 BOTTLE, PLASTIC | CAPSULE, LIQUID FILLED | 80 | 2 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Aleve liquid gels
- Naproxen Sodium
- AMMONIA
- FD&C BLUE NO. 1
- GELATIN, UNSPECIFIED
- GLYCERIN
- LACTIC ACID, UNSPECIFIED FORM
- MANNITOL
- POLYETHYLENE GLYCOL, UNSPECIFIED
- POLYVINYL ACETATE PHTHALATE
- POVIDONE, UNSPECIFIED
- PROPYLENE GLYCOL
- WATER
- SORBITAN
- SORBITOL
- TITANIUM DIOXIDE
- NAPROXEN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0280-0105 | 0280-0105-02, 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.
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 |
|---|---|---|---|---|---|---|---|
| A214463-001 | NAPROXEN SODIUM | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2023-01-10 |
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 | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A214463-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2023-01-10 | c2088c7a36db… | ||
| 2026-09-14 22:38:34 | 2026-08 | A214463-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2023-01-10 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A214463-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2023-01-10 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A214463-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2023-01-10 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214463-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2023-01-10 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A214463-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2023-01-10 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214463-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2023-01-10 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A214463-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2023-01-10 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A214463-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2023-01-10 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A214463-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2023-01-10 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A214463-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2023-01-10 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A214463-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2023-01-10 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A214463-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2023-01-10 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A214463-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2023-01-10 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A214463-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2023-01-10 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A214463-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2023-01-10 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A214463-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2023-01-10 | 8072bd15b7f6… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A214463-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2023-01-10 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A214463-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2023-01-10 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A214463-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2023-01-10 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A214463-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2023-01-10 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A214463-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2023-01-10 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A214463-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2023-01-10 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A214463-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2023-01-10 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A214463-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2023-01-10 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A214463-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2023-01-10 | 3bdfa0b2c4d7… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A214463-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2023-01-10 | a50c72e98297… |
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 liquid gels | NAPROXEN SODIUM | Bayer Healthcare LLC | a0587c73-d297-462d-a0ef-750cb324486e | 2024-05-06 | Warnings | 0280-0105-06 0280-0105-01 0280-0105-04 0280-0105-03 0280-0105-05 0280-0105-02 0280-0105 00280010505 00280010503 00280010502 00280010504 00280010506 00280010501 2766b060-5c1b-41fb-b8ca-cfb1a021b64e a0587c73-d297-462d-a0ef-750cb324486e |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.











