FDA.reportPublic FDA data

Naproxen Sodium 220mg

Manufacturer
Allegiant Health
Effective date
2021-04-21
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-05-31 23:54:59

Label at a glance#

ProductNaproxen Sodium 220mg
Active ingredientNAPROXEN SODIUM
Label structure10 sections

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 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

Storage and handling

store at 20° to 25°C (68° to 77°F). Avoid high humidity and excessive heat above 40°C (104°F).

Label contents#

Full prescribing information#

Active ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Naproxen sodium 220mg
(naproxen 200mg) (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Use(s)

INDICATIONS & USAGE SECTION

temporarily relieves minor aches and pains due to:

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

Warnings

WARNINGS SECTION

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 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
  • 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

Pregnancy/Breastfeeding

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 (1-800-222-1222) right away

Other Warnings

WARNINGS AND PRECAUTIONS 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

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 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

SPL UNCLASSIFIED SECTION

  • each caplet contains: sodium 20 mg
  • do not use if tamper evident seal under bottle is broken or missing

Storage

STORAGE AND HANDLING SECTION

  • store at 20° to 25°C (68° to 77°F). Avoid high humidity and excessive heat above 40°C (104°F).

Inactive ingredients

INACTIVE INGREDIENT SECTION

Inactive ingredients FD&C blue #2 aluminum
lake, hypromellose, microcrystalline cellulose,
polyethylene glycol, povidone, titanium dioxide
May contain: corn starch, croscarmellose sodium,
magnesium stearate, purified water, silicon

Questions

OTC - QUESTIONS SECTION

Call 1-888-952-0050 Monday through Friday 9AM- 5PM EST.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NaproxenNaproxen

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
849574naproxen sodium 220 MG Oral TabletPSN9
849574naproxen sodium 220 MG Oral TabletSCD9
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSY9

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69168-395-07Naproxen Sodium 220mg10 in 1 BOTTLETABLET, COATED109
69168-395-17Naproxen Sodium 220mg300 in 1 BOTTLETABLET, COATED3009
69168-395-50Naproxen Sodium 220mg50 in 1 BOTTLETABLET, COATED509

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69168-395NAPROXEN SODIUM 220MG TABLET, COATED [ALLEGIANT HEALTH]9Current NDC, Legacy NDC, 3 package rows20230519_14554f05-14e1-4c52-99ce-94561c42c0da.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69168-39569168-395-17, 69168-395-50, 69168-395-07

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
NAPROXEN SODIUM9TN87S3A3CACTIB
STARCH, CORNO8232NY3SJIACT
FD&C BLUE NO. 2--ALUMINUM LAKE4AQJ3LG584IACT
HYPROMELLOSES3NXW29V3WOIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POVIDONEFZ989GH94EIACT
WATER059QF0KO0RIACT
STEARIC ACID4ELV7Z65APIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
MAGNESIUM STEARATE70097M6I30IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM STARCH GLYCOLATE TYPE BSP4S77AHO6IACT

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 44.

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 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A090545-001NAPROXEN SODIUM220MGTABLET / ORAL2011-03-16c2088c7a36db…
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…

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
Naproxen Sodium 220mgNAPROXEN SODIUM 220MGAllegiant Health14554f05-14e1-4c52-99ce-94561c42c0da2021-04-21WarningsExact identifier
ndc (package): 69168-395-50
ndc (package): 69168-395-07
ndc (package): 69168-395-17
ndc (product): 69168-395
ndc11 (package): 69168039517
ndc11 (package): 69168039507
ndc11 (package): 69168039550
spl id: 08dc5597-5820-47c7-aec4-72336b5b7089
spl set id: 14554f05-14e1-4c52-99ce-94561c42c0da

Reported adverse events (FAERS/openFDA)#

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