Naproxen Sodium

Manufacturer
Geri-Care Pharmaceutical Corp
Effective date
2018-12-03
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:44:54

Label at a glance#

ProductNaproxen Sodium
Active ingredientNAPROXEN SODIUM
Label structure17 sections

Indications and uses

temporarily relieves minor aches and pain due to: backache muscular aches minor pain of arthritis 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 to12 hours while symptoms last for first dose you may take 2 tablets with in 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

  Store at 20-25 o C (68-77 o F). Avoid high humidity and excessive heat above 40 0 C (104 0 F)

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 pain due to:

  • backache
  • muscular aches
  • minor pain of arthritis
  • menstrual cramps
  • headache
  • toothache
  • the common cold

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:

  • 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.

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 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

Ask a doctor or pharmacist before use if

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
  • the risk of heart attack or stroke may increase if you use more
    than directed or for longer than directed

Stop use and ask 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 a stomach pain that dose 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.

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 to12 hours while symptoms last
  • for first dose you may take 2 tablets with in 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

STORAGE AND HANDLING SECTION

 

  • Store at 20-25 oC (68-77 oF). Avoid high humidity and excessive heat above 40 0C (104 0F)

Other information

SPL UNCLASSIFIED SECTION

  • each tablet contains: sodium 20 mg
  • If side effects occur, you may report side effects to
    FDA at 1-800-FDA-1088

Inactive ingredients

INACTIVE INGREDIENT SECTION


Colloidal silicon dioxide, croscarmellose sodium, FD&C blue #2 lake, Hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone,  titanium dioxide.

 

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-540-3765

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

951951

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57896-951-01EA - Each57896-95129f0b2f2-d28e-452d-9db8-824f8d97a99812018-01-12
57896-951-05EA - Each57896-951a81829c8-a0ce-4b41-94e1-475af887dc6c12018-01-12

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
57896-95157896-951-01, 57896-951-05, 57896-951-50

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Source Document#

Source XML · Source PDF

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
A090545-001NAPROXEN SODIUMNAPROXEN SODIUM220MGTABLET / ORAL2011-03-16

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 22:38:342026-08A090545-001NAPROXEN SODIUM220MGTABLET / ORAL2011-03-1684e616aacf4f…
2026-08-18 06:07:402026-07A090545-001NAPROXEN SODIUM220MGTABLET / ORAL2011-03-16caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090545-001NAPROXEN SODIUM220MGTABLET / ORAL2011-03-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090545-001NAPROXEN SODIUM220MGTABLET / ORAL2011-03-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A090545-001NAPROXEN SODIUM220MGTABLET / ORAL2011-03-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090545-001NAPROXEN SODIUM220MGTABLET / ORAL2011-03-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090545-001NAPROXEN SODIUM220MGTABLET / ORAL2011-03-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090545-001NAPROXEN SODIUM220MGTABLET / ORAL2011-03-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090545-001NAPROXEN SODIUM220MGTABLET / ORAL2011-03-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090545-001NAPROXEN SODIUM220MGTABLET / ORAL2011-03-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090545-001NAPROXEN SODIUM220MGTABLET / ORAL2011-03-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090545-001NAPROXEN SODIUM220MGTABLET / ORAL2011-03-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090545-001NAPROXEN SODIUM220MGTABLET / ORAL2011-03-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090545-001NAPROXEN SODIUM220MGTABLET / ORAL2011-03-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090545-001NAPROXEN SODIUM220MGTABLET / ORAL2011-03-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090545-001NAPROXEN SODIUM220MGTABLET / ORAL2011-03-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090545-001NAPROXEN SODIUM220MGTABLET / ORAL2011-03-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090545-001NAPROXEN SODIUM220MGTABLET / ORAL2011-03-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090545-001NAPROXEN SODIUM220MGTABLET / ORAL2011-03-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090545-001NAPROXEN SODIUM220MGTABLET / ORAL2011-03-1674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090545-001NAPROXEN SODIUM220MGTABLET / ORAL2011-03-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090545-001NAPROXEN SODIUM220MGTABLET / ORAL2011-03-16782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090545-001NAPROXEN SODIUM220MGTABLET / ORAL2011-03-1687673890dc5c…
2021-03-12 10:30 UTC2021-03A090545-001NAPROXEN SODIUM220MGTABLET / ORAL2011-03-165aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090545-001NAPROXEN SODIUM220MGTABLET / ORAL2011-03-168869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090545-001NAPROXEN SODIUM220MGTABLET / ORAL2011-03-16c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090545-001NAPROXEN SODIUM220MGTABLET / ORAL2011-03-163f01610625f2…
2019-09-15 20:21 UTC2019-09A090545-001NAPROXEN SODIUMEQ 200MG BASETABLET / ORAL2011-03-16b00525d2431f…
2019-07-19 19:46 UTC2019-07A090545-001NAPROXEN SODIUMEQ 200MG BASETABLET / ORAL2011-03-16ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090545-001NAPROXEN SODIUM220MGTABLET / ORAL2011-03-166a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090545-001NAPROXEN SODIUM220MGTABLET / ORAL2011-03-161c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090545-001NAPROXEN SODIUM220MGTABLET / ORAL2011-03-16ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090545-001NAPROXEN SODIUM220MGTABLET / ORAL2011-03-16a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090545-001NAPROXEN SODIUM220MGTABLET / ORAL2011-03-169b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090545-001NAPROXEN SODIUM220MGTABLET / ORAL2011-03-16a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090545-001NAPROXEN SODIUM220MGTABLET / ORAL2011-03-163f0d92c62455…
2023-05-13 08:27 UTC2023-05A090545-001NAPROXEN SODIUM220MGTABLET / ORAL2011-03-16053a50430f4f…
2023-01-26 05:58 UTC2023-01A090545-001NAPROXEN SODIUM220MGTABLET / ORAL2011-03-163bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090545-001NAPROXEN SODIUM220MGTABLET / ORAL2011-03-163a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090545-001NAPROXEN SODIUM220MGTABLET / ORAL2011-03-16f41ea6bd6efb…

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.

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
b6730de9-c766-af7b-e053-2995a90a05e46156240f-b245-cf2c-e053-2a91aa0a87a72020-12-14WarningsExact identifier
spl set id: 6156240f-b245-cf2c-e053-2a91aa0a87a7

Reported adverse events (FAERS/openFDA)#

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