Aleve

Manufacturer: Navajo Manufacturing Company Inc
Effective date: 2023-03-01
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-05-31 23:54:19

Label at a glance#

ProductAleve

Active ingredientNAPROXEN SODIUM

Label structure9 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

Contacts and useful links#

PhoneLabel contact1-800-395-0689

Websitewww.aleve.com

www.aleve.com

Label contents#

Full prescribing information#

Active ingredient (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

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

*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

WARNINGS SECTION

Allergy alert

Naproxen sodium may cause a severe allergic reaction, especialy in people allergic to asprin. Symptoms may include:

hives
facial swelling
asthma (wheezing)
shock
skin reddening
rash
blister

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 chace 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, napoxen, or others)
have 3 or more alcoholic drinks every day while using this product
take more or for a longer time 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, 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

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 any other drug

OTC - WHEN USING SECTION

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

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
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 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.

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

OTHER SAFETY INFORMATION

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

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) or www.aleve.com

PRINCIPAL DISPLAY PANEL - 12 POUCH DISPENSIT

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Aleve

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
849728	Aleve 220 MG Oral Tablet	PSN	3
849574	naproxen sodium 220 MG Oral Tablet	PSN	3
849728	naproxen sodium 220 MG Oral Tablet [Aleve]	SBD	3
849574	naproxen sodium 220 MG Oral Tablet	SCD	3
849728	Aleve 220 MG Oral Tablet	SY	3
849574	naproxen sodium 220 MG (as naproxen 200 MG) Oral Tablet	SY	3

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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
67751-144-03	2023-03-01	C162847	48780-1	f386c649-ac74-0266-e053-dadaa90a7c1a	Aleve
67751-144-04	2023-03-01	C162847	48780-1	f386c649-ac74-0266-e053-dadaa90a7c1a	Aleve
67751-144-05	2023-03-01	C162847	48780-1	f386c649-ac74-0266-e053-dadaa90a7c1a	Aleve
67751-144-03	2023-01-30	C162847	48780-1	f386c649-ac74-0266-e053-dadaa90a7c1a	Aleve
67751-144-04	2023-01-30	C162847	48780-1	f386c649-ac74-0266-e053-dadaa90a7c1a	Aleve
67751-144-05	2023-01-30	C162847	48780-1	f386c649-ac74-0266-e053-dadaa90a7c1a	Aleve

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
67751-144-03	Aleve	1 in 1 CARTON	TABLET	1	3
67751-144-03	Aleve	1 in 1 POUCH	TABLET	1	3
67751-144-04	Aleve	2 in 1 CARTON	TABLET	2	3
67751-144-04	Aleve	1 in 1 POUCH	TABLET	1	3
67751-144-05	Aleve	12 in 1 TRAY	TABLET	12	3
67751-144-05	Aleve	1 in 1 POUCH	TABLET	1	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67751-144	ALEVE (NAPROXEN SODIUM) TABLET [NAVAJO MANUFACTURING COMPANY INC]	3	Current NDC, Legacy NDC, 6 package rows	20230302_60637aeb-deb6-4747-e053-2a91aa0ad00b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0280-6000-10	EA - Each	0280-6000	3d7e705c-0aa1-49a0-b403-7f22091eab54	1	2022-02-07
0280-6000-24	EA - Each	0280-6000	b221ea71-b2e4-474c-a035-30da3e9e65e5	1	2021-07-15
0280-6000-32	EA - Each	0280-6000	d95d3b04-0998-4a1e-8379-c0a2c5ac0cd2	1	2014-09-03
0280-6000-50	EA - Each	0280-6000	e24c97ad-b92b-4c49-a641-af94b290daa0	1	2023-07-06

Products#

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

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

Aleve
naproxen sodium
HYPROMELLOSES
TITANIUM DIOXIDE
POVIDONE
TALC
MAGNESIUM STEARATE
FD&C BLUE NO. 2
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL, UNSPECIFIED
NAPROXEN

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
67751-144	67751-144-03, 67751-144-04, 67751-144-05
0280-6000

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
HYPROMELLOSES	3NXW29V3WO	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
POVIDONE	FZ989GH94E	IACT
TALC	7SEV7J4R1U	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
FD&C BLUE NO. 2	L06K8R7DQK	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
NAPROXEN SODIUM	9TN87S3A3C	ACTIB

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Aleve	NAPROXEN SODIUM	Navajo Manufacturing Company Inc.	590f3be2-20df-4643-9114-e7ed4cf9155c	2026-04-08	Warnings	Exact identifier ndc (product): 67751-144
Aleve Caplets	NAPROXEN SODIUM	Bayer HealthCare LLC.	a3745850-3e32-4884-b315-161bcb9996ed	2025-12-04		Exact identifier ndc (product): 0280-6000
Aleve	NAPROXEN SODIUM	Navajo Manufacturing Company Inc	60637aeb-deb6-4747-e053-2a91aa0ad00b	2023-03-01	Warnings	Exact identifier ndc (package): 67751-144-05 ndc (package): 67751-144-04 ndc (package): 67751-144-03 ndc (product): 67751-144 ndc11 (package): 67751014404 ndc11 (package): 67751014403 ndc11 (package): 67751014405 spl id: f5db63e0-e9f5-ec67-e053-2995a90a6f90 spl set id: 60637aeb-deb6-4747-e053-2a91aa0ad00b

Reported adverse events (FAERS/openFDA)#

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