Naproxen Sodium

Manufacturer: CVS PHARMACY | LNK International, Inc.
Effective date: 2022-12-17
Label type: HUMAN OTC DRUG LABEL
Version: 6
Source: legacy-cache
Hydrated at: 2026-08-01 21:44:05

Label at a glance#

ProductNaproxen Sodium

Active ingredientNAPROXEN SODIUM

Label structure9 sections

Indications and uses

temporarily relieves minor aches and pains due to: backache muscular aches the common cold toothache headache menstrual cramps minor pain of arthritis 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 tablet every 8 to 12 hours while symptoms last for the first dose you may take 2 tablets within the first hour do not exceed 2 tablets in any 8- to 12-hour period do not exceed 3 tablets in a 24-hour period children under 12 years: ask a doctor

Storage and handling

each tablet contains: sodium 20 mg store at 20°-25°C (68°-77°F). Avoid high humidity and excessive heat above 40°C (104°F) see end flap for expiration date and lot number

Contacts and useful links#

PhoneLabel contact1-800-426-9391

PhoneLabel contact1-800-SHOP CVS

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)*
*nonsteroidal anti-inflammatory drug

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

temporarily relieves minor aches and pains due to:
- backache
- muscular aches
- the common cold
- toothache
- headache
- menstrual cramps
- minor pain of arthritis
temporarily reduces fever

Warnings

WARNINGS SECTION

Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

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

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.

Do not use

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR SECTION

the stomach bleeding warning applies to you
you have a history of stomach problems, such as heartburn
you are taking a diuretic
you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke
you have problems or serious side effects from taking pain relievers or fever reducers

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

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

When using this product

OTC - WHEN USING SECTION

take with food or milk if stomach upset occurs

Stop use and ask a doctor if

OTC - STOP USE SECTION

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:
- leg swelling
- chest pain
- slurred speech
- trouble breathing
- weakness in one part or side of body
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

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

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.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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 tablet every 8 to 12 hours while symptoms last
- for the first dose you may take 2 tablets within the first hour
- do not exceed 2 tablets in any 8- to 12-hour period
- do not exceed 3 tablets in a 24-hour period
children under 12 years: ask a doctor

Other information

STORAGE AND HANDLING SECTION

each tablet contains: sodium 20 mg
store at 20°-25°C (68°-77°F). Avoid high humidity and excessive heat above 40°C (104°F)
see end flap for expiration date and lot number

Inactive ingredients

INACTIVE INGREDIENT SECTION

croscarmellose sodium, FD&C blue #2 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, talc, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVSHealth®

Compare to the active ingredient in Aleve® Back & Muscle Pain†

Tablets

Naproxen
Sodium
TABLETS, 220 mg

Pain Reliever,
Fever Reducer (NSAID)

STRENGTH TO LAST 12 HOURS

BACK & MUSCLE PAIN

24 TABLETS

Actual Size

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

†This product is not manufactured or distributed by Bayer HealthCare LLC, owner of the registered trademark Aleve^® Back & Muscle Pain.

50844 ORG052041708

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
©2021 CVS/pharmacy
CVS.com^® 1-800-SHOP CVS

V-11112

CVS^®Quality
Money Back Guarantee

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

Naproxen Sodium
NAPROXEN
CROSCARMELLOSE SODIUM
FD&C BLUE NO. 2--ALUMINUM LAKE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYVINYL ALCOHOL, UNSPECIFIED
POVIDONE, UNSPECIFIED
SILICON DIOXIDE
TALC
TITANIUM DIOXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
69842-417	69842-417-08, 69842-417-15, 69842-417-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
NAPROXEN SODIUM	9TN87S3A3C	ACTIB
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
FD&C BLUE NO. 2--ALUMINUM LAKE	4AQJ3LG584	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
POLYVINYL ALCOHOL, UNSPECIFIED	532B59J990	IACT
POVIDONE, UNSPECIFIED	FZ989GH94E	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
TALC	7SEV7J4R1U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	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 44.

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
A204872-001	NAPROXEN SODIUM	NAPROXEN SODIUM	220MG	TABLET / ORAL			2017-01-23

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 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204872-001	NAPROXEN SODIUM	EQ 200MG BASE	TABLET / ORAL	2017-01-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204872-001	NAPROXEN SODIUM	EQ 200MG BASE	TABLET / ORAL	2017-01-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`3a93d1ddd44b…`

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
ec8d3c6b-21d7-4b50-ae35-4451cf6bbdef			4b9b33bd-9dab-4778-b2fb-a62104b7c1e0	2022-12-17	Warnings	Exact identifier spl id: ec8d3c6b-21d7-4b50-ae35-4451cf6bbdef spl set id: 4b9b33bd-9dab-4778-b2fb-a62104b7c1e0

Reported adverse events (FAERS/openFDA)#

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