Naproxen Sodium

Manufacturer
TOP CARE (Topco Associates LLC)
Effective date
2025-05-01
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
legacy-cache
Hydrated at
2026-08-01 20:39:24

Label at a glance#

ProductNaproxen Sodium
Active ingredientNAPROXEN SODIUM
Label structure10 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 if taken with food, this product may take longer to work adults and children 12 years and older take 1 capsule every 8 to 12 hours while symptoms last for the first dose you may take 2 capsules within the first hour do not exceed 2 capsules in any 8- to 12-hour period do not exceed 3 capsules in a 2...

Storage and handling

each capsule contains: sodium 20 mg store at 20-25°C (68-77°F). Avoid high humidity and excessive heat above 40°C (104°F). read all directions and warnings before use. Keep carton. swallow whole; do not crush, chew, or dissolve

Label contents#

Full prescribing information#

Active ingredient (in each capsule)

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, 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
  • have 3 or more alcoholic drinks every day while using this product
  • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
  • take more or for a longer time than directed

Heart attack and stroke: 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 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
    • have bloody or black stools
    • vomit blood
    • have stomach pain that does not get better
  • you have symptoms of heart problems or stroke:
    • chest pain
    • trouble breathing
    • leg swelling
    • slurred speech
    • 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
  • redness or swelling is present in the painful area
  • any new symptoms appear
  • you have difficulty swallowing
  • it feels like the capsule is stuck in your throat

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.(1-800-222-1222).

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
  • if taken with food, this product may take longer to work
  • adults and children 12 years and older
    • take 1 capsule every 8 to 12 hours while symptoms last
    • for the first dose you may take 2 capsules within the first hour
    • do not exceed 2 capsules in any 8- to 12-hour period
    • do not exceed 3 capsules in a 24-hour period
  • children under 12 years: ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • each capsule contains: sodium 20 mg
  • store at 20-25°C (68-77°F). Avoid high humidity and excessive heat above 40°C (104°F).
  • read all directions and warnings before use. Keep carton.
  • swallow whole; do not crush, chew, or dissolve

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C blue #1, gelatin, glycerin, lactic acid, lecithin, light mineral oil, n-butyl alcohol, polyethylene glycol, povidone, propylene glycol, purified water, shellac glaze, sorbitan, sorbitol solution, titanium dioxide, white ink

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-888-423-0139

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COMPARE TO ALEVE® ACTIVE INGREDIENT†

Naproxen Sodium Capsules, 220 mg

PAIN RELIEVER • FEVER REDUCER (NSAID)

Strength to lasts 12 hours

LIQUID-FILLED CAPSULES

†This product is not manufactured or distributed by Bayer HealthCare, LLC distributor of Aleve®.

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

©TOPCO PLVA0318 

topcare@topco.com www.topcarebrand.com

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TOP CARE HEALTH Naproxen Sodium Capsules 220 mg
TOP CARE HEALTH Naproxen Sodium Capsules 220 mg

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-748NAPROXEN SODIUM CAPSULE, LIQUID FILLED [TOP CARE (TOPCO ASSOCIATES LLC)]7Legacy NDC20250502_e4696104-e701-4886-9932-e8eca02278eb.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
36800-74836800-748-20, 36800-748-40, 36800-748-80

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 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
A208363-001NAPROXEN SODIUMNAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2018-03-15

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
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2026-08-18 06:07:402026-07A208363-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2018-03-15caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208363-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2018-03-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208363-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2018-03-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A208363-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2018-03-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208363-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2018-03-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208363-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2018-03-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208363-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2018-03-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208363-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2018-03-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208363-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2018-03-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208363-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2018-03-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208363-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2018-03-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208363-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2018-03-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208363-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2018-03-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208363-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2018-03-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208363-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2018-03-158072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208363-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2018-03-155c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A208363-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2018-03-155d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A208363-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2018-03-154b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A208363-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2018-03-1574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A208363-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2018-03-15bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A208363-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2018-03-15782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A208363-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2018-03-1587673890dc5c…
2021-03-12 10:30 UTC2021-03A208363-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2018-03-155aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A208363-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2018-03-158869cabd3fbd…
2020-11-12 02:37 UTC2020-11A208363-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2018-03-15c0c555d07b60…
2019-12-14 00:12 UTC2019-12A208363-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2018-03-153f01610625f2…
2019-09-15 20:21 UTC2019-09A208363-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2018-03-15b00525d2431f…
2019-07-19 19:46 UTC2019-07A208363-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2018-03-15ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A208363-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2018-03-156a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A208363-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2018-03-151c564ffb4f44…
2023-12-20 04:57 UTC2023-12A208363-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2018-03-15ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A208363-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2018-03-15a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A208363-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2018-03-159b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A208363-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2018-03-15a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A208363-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2018-03-153f0d92c62455…
2023-05-13 08:27 UTC2023-05A208363-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2018-03-15053a50430f4f…
2023-01-26 05:58 UTC2023-01A208363-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2018-03-153bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A208363-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2018-03-153a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A208363-001NAPROXEN SODIUMEQ 200MG BASECAPSULE / ORAL2018-03-15f41ea6bd6efb…

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
c3e4419d-4fb7-4db6-9c76-212ecaac39f7e4696104-e701-4886-9932-e8eca02278eb2025-05-01WarningsExact identifier
spl id: c3e4419d-4fb7-4db6-9c76-212ecaac39f7
spl set id: e4696104-e701-4886-9932-e8eca02278eb

Reported adverse events (FAERS/openFDA)#

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