Aleve ® Tablets - Blueshield UI 1614642

Manufacturer: Bayer HealthCare LLC.
Effective date: 2025-04-01
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-06-01 01:13:11

Label at a glance#

ProductAleve

Active ingredientNAPROXEN SODIUM

Label structure11 sections

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

Dosage and administration

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

Storage and handling

each caplet contains: sodium 21 mg store at 20-25 ° C (68-77 ° F). Avoid high humidity and excessive heat above 40 ° C (104 ° F).

Contacts and useful links#

PhoneLabel contact1-800-395-0689

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Naproxen sodium 220 mg (naproxen 200 mg) (NSAID) ¹

1 *nonsteroidal anti-inflammatory drug

Purposes

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

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

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

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 conidtion
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 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 healthcare 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 un 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.

Directions

DOSAGE & ADMINISTRATION SECTION

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 information

STORAGE AND HANDLING SECTION

each caplet contains: sodium 21 mg
store at 20-25 ° C (68-77 ° F). Avoid high humidity and excessive heat above 40 ° C (104 ° F).

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, FD&C blue No. 2 aluminum lake, hypromellose, magnesium stearate, mannitol, polyethylene glycol, sodium starch glycolate, stearic acid, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

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

PDP - Aleve Tablets

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDP

PDP- Easy Open Arthritis Cap

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDP

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
849728	Aleve 220 MG Oral Tablet	PSN	1
849574	naproxen sodium 220 MG Oral Tablet	PSN	1
849728	naproxen sodium 220 MG Oral Tablet [Aleve]	SBD	1
849574	naproxen sodium 220 MG Oral Tablet	SCD	1
849728	Aleve 220 MG Oral Tablet	SY	1
849574	naproxen sodium 220 MG (as naproxen 200 MG) Oral Tablet	SY	1

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
NAPROXEN Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20191108

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fef6ad89-235f-4274-ba49-a8e53642473e	Product name	2	20250225
87fed3e6-8fba-48ef-96b0-3a7fb54b96ff	Product name	3	20230306
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
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
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508
ce67e27d-1d21-5465-4409-b0662dd99d4d	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0280-0113-01	Aleve	10 in 1 BOTTLE	TABLET	10	1
0280-0113-02	Aleve	24 in 1 BOTTLE	TABLET	24	1
0280-0113-02	Aleve	1 in 1 CARTON	TABLET	1	1
0280-0113-03	Aleve	270 in 1 BOTTLE	TABLET	270	1
0280-0113-03	Aleve	1 in 1 CARTON	TABLET	1	1
0280-0113-04	Aleve	50 in 1 BOTTLE	TABLET	50	1
0280-0113-04	Aleve	1 in 1 CARTON	TABLET	1	1
0280-0113-05	Aleve	1 in 1 CARTON	TABLET	1	1
0280-0113-05	Aleve	90 in 1 BOTTLE	TABLET	90	1
0280-0113-06	Aleve	1 in 1 CARTON	TABLET	1	1
0280-0113-06	Aleve	110 in 1 BOTTLE	TABLET	110	1
0280-0131-01	AleveEasy Open Arthritis	200 in 1 BOTTLE	TABLET	200	1

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

Aleve
NAPROXEN SODIUM
POLYETHYLENE GLYCOL, UNSPECIFIED
STEARIC ACID
MANNITOL
FD&C BLUE NO. 2
MAGNESIUM STEARATE
NAPROXEN
SILICON DIOXIDE
HYPROMELLOSES
SODIUM CARBOXYMETHYL STARCH
TITANIUM DIOXIDE
Aleve Easy Open Arthritis

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0280-0113	0280-0113-01, 0280-0113-02, 0280-0113-03, 0280-0113-04, 0280-0113-05, 0280-0113-06
0280-0131	0280-0131-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
STEARIC ACID	4ELV7Z65AP	IACT
MANNITOL	3OWL53L36A	IACT
FD&C BLUE NO. 2	L06K8R7DQK	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
NAPROXEN SODIUM	9TN87S3A3C	ACTIM
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
HYPROMELLOSES	3NXW29V3WO	IACT
SODIUM CARBOXYMETHYL STARCH	H8AV0SQX4D	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
STEARIC ACID	4ELV7Z65AP	IACT
MANNITOL	3OWL53L36A	IACT
NAPROXEN SODIUM	9TN87S3A3C	ACTIB
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
FD&C BLUE NO. 2	L06K8R7DQK	IACT
HYPROMELLOSES	3NXW29V3WO	IACT
SODIUM CARBOXYMETHYL STARCH	H8AV0SQX4D	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
MAGNESIUM STEARATE	70097M6I30	IACT

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-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.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	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.

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

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Aleve	NAPROXEN SODIUM	Bayer HealthCare LLC.	31bad2d9-c0bb-7f20-e063-6294a90acb17	2025-04-01	Warnings	Exact identifier ndc (package): 0280-0113-02 ndc (package): 0280-0131-01 ndc (package): 0280-0113-06 ndc (package): 0280-0113-04 ndc (package): 0280-0113-01 ndc (package): 0280-0113-03 ndc (package): 0280-0113-05 ndc (product): 0280-0131 ndc (product): 0280-0113 ndc11 (package): 00280011304 ndc11 (package): 00280011302 ndc11 (package): 00280011306 ndc11 (package): 00280011303 ndc11 (package): 00280013101 ndc11 (package): 00280011305 ndc11 (package): 00280011301 spl id: 31bad2d9-c0ba-7f20-e063-6294a90acb17 spl set id: 31bad2d9-c0bb-7f20-e063-6294a90acb17

Reported adverse events (FAERS/openFDA)#

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