NAPROXEN SODIUM TABLETS

Manufacturer
SAVE-A-LOT FOOD STORES, LTD.
Effective date
2022-11-23
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:46:30

Label at a glance#

ProductNAPROXEN SODIUM
Active ingredientNAPROXEN SODIUM
Label structure17 sections

Indications and uses

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

Storage and handling

each tablet contains: sodium 20 mg store between 20°-25°C(68-77°F). Avoid high humidity and excessive heat above 40°C(104°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Naproxen sodium 220 mg

(naproxen 200 mg) (NSAID)*

*nonsteroidal anti-inflammatory drug

OTC - PURPOSE SECTION

Pain reliever/

fever reducer

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

Warnings

Allergy alert

SPL UNCLASSIFIED SECTION

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

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

If an allergic reaction occurs, stop use and seek medical help right away.

Stomach bleeding warning

SPL UNCLASSIFIED SECTION

This product contains a non steroidal anti-inflammatory drug(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

SPL UNCLASSIFIED SECTION

NSAID's except aspirin increases 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 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 a heartburn
  • you have a high blood pressure, heart disease, liver cirrhosis or kidney disease
  • you are taking a diuretic
  • you have problems or serious side effects taking pain relievers or fever reducers
  • you have asthma

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • under a doctor 's care for any serious conditions
  • 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 a doctor if

OTC - STOP USE SECTION

  • you experience any of following sign of stomach bleeding:
  • feel faint
  • vomit blood
  • have bloody or black stools
  • have stomach pain that does 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 feel 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 profession 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 complication during the delivery.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a position 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
 Adults and Children 12 years and older:
  • take one tablet every 8 to 12 hours while symptoms last
  • for the first dose you may take within the first hour
  • do not exceed 2 tablets in any 8 to 12 hours period
  • do not exceed 3 tablets in 24 hour period
 Children under 12 years:
  •  Ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • each tablet contains: sodium 20 mg
  • store between 20°-25°C(68-77°F). Avoid high humidity and excessive heat above 40°C(104°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide*,croscarmellose sodium*, FD&C Blue#2 lake,hypromellose, magnesium stearate*, maize starch*, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate*,stearic acid*, titanium dioxide.
*contains one or more of these ingredients

SPL UNCLASSIFIED SECTION

Questions or comments?

1-888-333-9792

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the active
ingredient in Aleve®*

ALL DAY
PAIN RELIEF

NAPROXEN SODIUM TABLETS, USP 220 mg

PAIN RELIEVER/FEVER REDUCER (NSAID)

image descriptionimage description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
46994-661-502024-01-30C16284748780-1d6a99b39-5330-a426-e053-dadaa90af4c2NAPROXEN SODIUM TABLETS
46994-661-502022-08-18C16284748780-1d6a99b39-5330-a426-e053-dadaa90af4c2NAPROXEN SODIUM TABLETS
46994-661-502022-01-28C16284748780-1d6a99b39-5330-a426-e053-dadaa90af4c2NAPROXEN SODIUM TABLETS

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
46994-66146994-661-50

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 · 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
A207612-001NAPROXEN SODIUMNAPROXEN SODIUM220MGTABLET / ORAL2018-11-16

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 22:38:342026-08A207612-001NAPROXEN SODIUM220MGTABLET / ORAL2018-11-1684e616aacf4f…
2026-08-18 06:07:402026-07A207612-001NAPROXEN SODIUM220MGTABLET / ORAL2018-11-16caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207612-001NAPROXEN SODIUM220MGTABLET / ORAL2018-11-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207612-001NAPROXEN SODIUM220MGTABLET / ORAL2018-11-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A207612-001NAPROXEN SODIUM220MGTABLET / ORAL2018-11-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207612-001NAPROXEN SODIUM220MGTABLET / ORAL2018-11-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207612-001NAPROXEN SODIUM220MGTABLET / ORAL2018-11-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207612-001NAPROXEN SODIUM220MGTABLET / ORAL2018-11-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207612-001NAPROXEN SODIUM220MGTABLET / ORAL2018-11-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207612-001NAPROXEN SODIUM220MGTABLET / ORAL2018-11-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207612-001NAPROXEN SODIUM220MGTABLET / ORAL2018-11-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207612-001NAPROXEN SODIUM220MGTABLET / ORAL2018-11-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207612-001NAPROXEN SODIUM220MGTABLET / ORAL2018-11-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207612-001NAPROXEN SODIUM220MGTABLET / ORAL2018-11-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207612-001NAPROXEN SODIUM220MGTABLET / ORAL2018-11-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207612-001NAPROXEN SODIUM220MGTABLET / ORAL2018-11-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207612-001NAPROXEN SODIUM220MGTABLET / ORAL2018-11-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207612-001NAPROXEN SODIUM220MGTABLET / ORAL2018-11-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207612-001NAPROXEN SODIUM220MGTABLET / ORAL2018-11-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207612-001NAPROXEN SODIUM220MGTABLET / ORAL2018-11-1674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207612-001NAPROXEN SODIUM220MGTABLET / ORAL2018-11-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207612-001NAPROXEN SODIUM220MGTABLET / ORAL2018-11-16782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207612-001NAPROXEN SODIUM220MGTABLET / ORAL2018-11-1687673890dc5c…
2021-03-12 10:30 UTC2021-03A207612-001NAPROXEN SODIUM220MGTABLET / ORAL2018-11-165aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A207612-001NAPROXEN SODIUM220MGTABLET / ORAL2018-11-168869cabd3fbd…
2020-11-12 02:37 UTC2020-11A207612-001NAPROXEN SODIUM220MGTABLET / ORAL2018-11-16c0c555d07b60…
2019-12-14 00:12 UTC2019-12A207612-001NAPROXEN SODIUM220MGTABLET / ORAL2018-11-163f01610625f2…
2019-09-15 20:21 UTC2019-09A207612-001NAPROXEN SODIUMEQ 200MG BASETABLET / ORAL2018-11-16b00525d2431f…
2019-07-19 19:46 UTC2019-07A207612-001NAPROXEN SODIUMEQ 200MG BASETABLET / ORAL2018-11-16ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A207612-001NAPROXEN SODIUM220MGTABLET / ORAL2018-11-166a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A207612-001NAPROXEN SODIUM220MGTABLET / ORAL2018-11-161c564ffb4f44…
2023-12-20 04:57 UTC2023-12A207612-001NAPROXEN SODIUM220MGTABLET / ORAL2018-11-16ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A207612-001NAPROXEN SODIUM220MGTABLET / ORAL2018-11-16a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A207612-001NAPROXEN SODIUM220MGTABLET / ORAL2018-11-169b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A207612-001NAPROXEN SODIUM220MGTABLET / ORAL2018-11-16a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A207612-001NAPROXEN SODIUM220MGTABLET / ORAL2018-11-163f0d92c62455…
2023-05-13 08:27 UTC2023-05A207612-001NAPROXEN SODIUM220MGTABLET / ORAL2018-11-16053a50430f4f…
2023-01-26 05:58 UTC2023-01A207612-001NAPROXEN SODIUM220MGTABLET / ORAL2018-11-163bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A207612-001NAPROXEN SODIUM220MGTABLET / ORAL2018-11-163a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A207612-001NAPROXEN SODIUM220MGTABLET / ORAL2018-11-16f41ea6bd6efb…

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
29bb729c-e753-933d-e063-6394a90a97ec914acd18-eb69-494a-8c43-75df62eca7222024-12-20WarningsExact identifier
spl set id: 914acd18-eb69-494a-8c43-75df62eca722

Reported adverse events (FAERS/openFDA)#

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