Naproxen Sodium

Manufacturer
HARMON STORES INC.
Effective date
2019-12-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:02:03

Label at a glance#

ProductNaproxen Sodium
Active ingredientNAPROXEN SODIUM
Label structure22 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 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...

Label contents#

Full prescribing information#

Active ingredient (For Tablet)

OTC - ACTIVE INGREDIENT SECTION

(in each tablet)

Naproxen sodium 220 mg

(naproxen 200 mg) (NSAID)**

**nonsteroidal anti-inflammatory drug

Active ingredient (For Caplet)

OTC - ACTIVE INGREDIENT SECTION

(in each caplet)

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

Allergy alert:

WARNINGS SECTION

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:

WARNINGS SECTION

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:

WARNINGS SECTION

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 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

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 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:

■ 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

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 the 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 (For Tablets)

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

Directions (For Caplets)

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 (For Tablet)

OTHER SAFETY INFORMATION

■ 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)

Other information (For Caplet)

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 aluminum lake, hypromellose, maize starch, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate, stearic acid, titanium dioxide.

Questions or comments?

OTC - QUESTIONS SECTION

1-877-770-3183 Mon - Fri 9:00 AM to 4:00 PM EST.

Tablets

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

50 Tablets50 Tablets

Caplets

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

50 Caplets50 Caplets100 Caplets100 Caplets

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
849574naproxen sodium 220 MG Oral TabletPSN2
849574naproxen sodium 220 MG Oral TabletSCD2
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
NAPROXEN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20191108

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fef6ad89-235f-4274-ba49-a8e53642473eProduct name220250225
87fed3e6-8fba-48ef-96b0-3a7fb54b96ffProduct name320230306
b5fdaaec-7251-4da6-9cb2-4e9e76939ec8Product name120200623
e76dbbc1-775d-722c-08ff-ed45e8a80defProduct name320181002
6f4f4521-fd56-1ae6-888b-3b021bd75c7cProduct name120140508
ce67e27d-1d21-5465-4409-b0662dd99d4dProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63940-761-05Naproxen Sodium50 in 1 BOTTLETABLET502
63940-763-05Naproxen Sodium50 in 1 BOTTLETABLET502
63940-763-10Naproxen Sodium100 in 1 BOTTLETABLET1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63940-761NAPROXEN SODIUM TABLET [HARMON STORES INC.]2Legacy NDC, 1 package rows20191218_76a17f69-0071-e102-e053-2991aa0a3a66.zip
63940-763NAPROXEN SODIUM TABLET [HARMON STORES INC.]2Legacy NDC, 2 package rows20191218_76a17f69-0071-e102-e053-2991aa0a3a66.zip

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63940-76163940-761-05
63940-76363940-763-05, 63940-763-10

Ingredients#

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

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

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A091353-001NAPROXEN SODIUMNAPROXEN SODIUM220MGTABLET / ORAL2011-09-20

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-2084e616aacf4f…
2026-08-18 06:07:402026-07A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-20caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-208072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-205c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-205d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-204b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-2074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-20bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-20782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-2087673890dc5c…
2021-03-12 10:30 UTC2021-03A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-205aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-208869cabd3fbd…
2020-11-12 02:37 UTC2020-11A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-20c0c555d07b60…
2019-12-14 00:12 UTC2019-12A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-203f01610625f2…
2019-09-15 20:21 UTC2019-09A091353-001NAPROXEN SODIUMEQ 200MG BASETABLET / ORAL2011-09-20b00525d2431f…
2019-07-19 19:46 UTC2019-07A091353-001NAPROXEN SODIUMEQ 200MG BASETABLET / ORAL2011-09-20ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-206a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-201c564ffb4f44…
2023-12-20 04:57 UTC2023-12A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-20ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-20a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-209b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-20a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-203f0d92c62455…
2023-05-13 08:27 UTC2023-05A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-20053a50430f4f…
2023-01-26 05:58 UTC2023-01A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-203bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-203a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A091353-001NAPROXEN SODIUM220MGTABLET / ORAL2011-09-20f41ea6bd6efb…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
99eb0620-baf1-5fa1-e053-2a95a90a03d976a17f69-0071-e102-e053-2991aa0a3a662019-12-17WarningsExact identifier
spl id: 99eb0620-baf1-5fa1-e053-2a95a90a03d9
spl set id: 76a17f69-0071-e102-e053-2991aa0a3a66

Reported adverse events (FAERS/openFDA)#

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