gc 951-954L

Manufacturer
NuCare Pharmaceuticals,Inc.
Effective date
2026-10-07
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
daily-update
Hydrated at
2026-10-10 01:03:00

Label at a glance#

ProductNaproxen
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 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

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.

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 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

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 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
  • 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

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

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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

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

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 1-800-540-3765

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

pdppdp

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeData Matrix0100368071503937210000000002<GS>170000010000000<GS>68071-5039-3.jpg

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-5039-12025-02-04C16284748780-12cef2736-a0fb-d83d-e063-dadaa90ab31fgc 951-954L
68071-5039-12025-02-04C16284748780-12cef2736-a0fb-d83d-e063-dadaa90ab31fgc 951-954L
68071-5039-12025-01-30C16284748780-12cef2736-a0fb-d83d-e063-dadaa90ab31fgc 951-954L
68071-5039-12025-01-30C16284748780-12cef2736-a0fb-d83d-e063-dadaa90ab31fgc 951-954L

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57896-954-01EA - Each57896-9543674a1eb-0ece-4426-a2f7-806088afe33612020-03-10

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68071-503968071-5039-1, 68071-5039-3
57896-954

Ingredients#

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

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

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32025-02-04full-release2026-06-01 00:54:25

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
A204872-001NAPROXEN SODIUMNAPROXEN SODIUM220MGTABLET / ORAL2017-01-23

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-2384e616aacf4f…
2026-08-18 06:07:402026-07A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-238072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-235c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-235d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-234b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-2374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-23bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-23782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-2387673890dc5c…
2021-03-12 10:30 UTC2021-03A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-235aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-238869cabd3fbd…
2020-11-12 02:37 UTC2020-11A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-23c0c555d07b60…
2019-12-14 00:12 UTC2019-12A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-233f01610625f2…
2019-09-15 20:21 UTC2019-09A204872-001NAPROXEN SODIUMEQ 200MG BASETABLET / ORAL2017-01-23b00525d2431f…
2019-07-19 19:46 UTC2019-07A204872-001NAPROXEN SODIUMEQ 200MG BASETABLET / ORAL2017-01-23ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-236a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-231c564ffb4f44…
2023-12-20 04:57 UTC2023-12A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-23ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-23a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-239b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-23a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-233f0d92c62455…
2023-05-13 08:27 UTC2023-05A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-23053a50430f4f…
2023-01-26 05:58 UTC2023-01A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-233bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-233a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A204872-001NAPROXEN SODIUM220MGTABLET / ORAL2017-01-23f41ea6bd6efb…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NaproxenNAPROXEN SODIUMGeri-Care Pharmaceutical Corp9a61d544-e46d-6703-e053-2a95a90a32fd2025-02-27WarningsExact identifier
ndc (product): 57896-954
NaproxenNAPROXEN SODIUMNuCare Pharmaceuticals,Inc.f1ed8384-83d6-6f2a-e053-2a95a90ab08f2025-02-04WarningsExact identifier
ndc (package): 68071-5039-1
ndc (product): 68071-5039
ndc11 (package): 68071503901
spl set id: f1ed8384-83d6-6f2a-e053-2a95a90ab08f

Reported adverse events (FAERS/openFDA)#

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