NAPROXEN SODIUM TABLETS USP, 220 mg

Manufacturer
Dr.Reddy's Laboratories Inc
Effective date
2025-07-22
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:08:18

Label at a glance#

ProductNaproxen Sodium Headache Pain Caplets
Active ingredientNaproxen Sodium
Label structure13 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 Adults and children 12 years and older take 1 tablet/caplet every 8 to 12 hours while symptoms last for the first dose you may take 2 tablets/caplets within the first hour do not exceed 2 tablets/caplets in any 8 to 12 hour period do not exceed 3 tablets/caplets in a 24-hour period Children under 12...

Storage and handling

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

Label contents#

Full prescribing information#

SPL PRODUCT DATA ELEMENTS SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

PAIN RELIEVER / FEVER REDUCER (NSAID)

Drug Facts

Active ingredient (in each tablet/caplet)

OTC - ACTIVE INGREDIENT SECTION

Naproxen sodium USP, 220 mg
(naproxen USP, 200 mg) (NSAID)1

1 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

SPL UNCLASSIFIED 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.

SPL UNCLASSIFIED SECTION

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding.

The chance is higher if you:

are age 60 or olderhave had stomach ulcers or bleeding problems

take a blood thinning (anticoagulant) or steroid drug

take other drugs containing prescription or nonprescription NSAID's (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

SPL UNCLASSIFIED SECTION

Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, hear failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.

OTC- ASK A DOCTOR SECTION

OTC - ASK DOCTOR SECTION

Ask a doctor before use if

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

OTC- DO NOT USE SECTION

OTC - DO NOT USE SECTION

Do not use 

if you have ever had an allergic reaction to any other pain reliever/fever reducer

right before or after heart surgery 

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are 

under a doctor's care for any serious condition

taking any other drug 

OTC - WHEN USING SECTION

When using this product

take with food or milk if stomach upset occurs

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 at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

OTC - STOP USE SECTION

Stop use and ask a doctor if

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 

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 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 1 tablet/caplet every 8 to 12 hours while symptoms last
  • for the first dose you may take 2 tablets/caplets within the first hour
  • do not exceed 2 tablets/caplets in any 8 to 12 hour period
  • do not exceed 3 tablets/caplets in a 24-hour period
Children under 12 years
  • ask a doctor

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD &C Blue # 2, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, talc, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

call toll-free weekdays 9 AM to 8 PM EST at 1-888-375-3784

SPL UNCLASSIFIED SECTION

Distributed by:

Dr. Reddy’s Laboratories, Inc.

Princeton, NJ 08540

Headache

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Headache Container Label:

ContainerContainer

Back and Muscle Pain

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Back and Muscle Pain- ContainerContainerContainer

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
849574naproxen sodium 220 MG Oral TabletPSN6
849574naproxen sodium 220 MG Oral TabletSCD6
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSY6

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
43598-059-52Naproxen Sodium Headache Pain Caplets225 in 1 BOTTLETABLET, COATED2256
43598-060-52Naproxen Sodium Back and Muscle Pain Caplets225 in 1 BOTTLETABLET, COATED2256

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43598-05943598-059-52
43598-06043598-060-52

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 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
A075168-001NAPROXEN SODIUMNAPROXEN SODIUM220MGTABLET / ORAL1998-07-28

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 22:38:342026-08A075168-001NAPROXEN SODIUM220MGTABLET / ORAL1998-07-2884e616aacf4f…
2026-08-18 06:07:402026-07A075168-001NAPROXEN SODIUM220MGTABLET / ORAL1998-07-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075168-001NAPROXEN SODIUM220MGTABLET / ORAL1998-07-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075168-001NAPROXEN SODIUM220MGTABLET / ORAL1998-07-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A075168-001NAPROXEN SODIUM220MGTABLET / ORAL1998-07-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075168-001NAPROXEN SODIUM220MGTABLET / ORAL1998-07-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075168-001NAPROXEN SODIUM220MGTABLET / ORAL1998-07-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075168-001NAPROXEN SODIUM220MGTABLET / ORAL1998-07-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075168-001NAPROXEN SODIUM220MGTABLET / ORAL1998-07-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075168-001NAPROXEN SODIUM220MGTABLET / ORAL1998-07-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075168-001NAPROXEN SODIUM220MGTABLET / ORAL1998-07-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075168-001NAPROXEN SODIUM220MGTABLET / ORAL1998-07-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075168-001NAPROXEN SODIUM220MGTABLET / ORAL1998-07-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075168-001NAPROXEN SODIUM220MGTABLET / ORAL1998-07-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075168-001NAPROXEN SODIUM220MGTABLET / ORAL1998-07-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075168-001NAPROXEN SODIUM220MGTABLET / ORAL1998-07-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075168-001NAPROXEN SODIUM220MGTABLET / ORAL1998-07-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075168-001NAPROXEN SODIUM220MGTABLET / ORAL1998-07-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075168-001NAPROXEN SODIUM220MGTABLET / ORAL1998-07-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075168-001NAPROXEN SODIUM220MGTABLET / ORAL1998-07-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075168-001NAPROXEN SODIUM220MGTABLET / ORAL1998-07-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075168-001NAPROXEN SODIUM220MGTABLET / ORAL1998-07-28782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075168-001NAPROXEN SODIUM220MGTABLET / ORAL1998-07-2887673890dc5c…
2021-03-12 10:30 UTC2021-03A075168-001NAPROXEN SODIUM220MGTABLET / ORAL1998-07-285aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075168-001NAPROXEN SODIUM220MGTABLET / ORAL1998-07-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075168-001NAPROXEN SODIUM220MGTABLET / ORAL1998-07-28c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075168-001NAPROXEN SODIUM220MGTABLET / ORAL1998-07-283f01610625f2…
2019-09-15 20:21 UTC2019-09A075168-001NAPROXEN SODIUMEQ 200MG BASETABLET / ORAL1998-07-28b00525d2431f…
2019-07-19 19:46 UTC2019-07A075168-001NAPROXEN SODIUMEQ 200MG BASETABLET / ORAL1998-07-28ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075168-001NAPROXEN SODIUM220MGTABLET / ORAL1998-07-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075168-001NAPROXEN SODIUM220MGTABLET / ORAL1998-07-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075168-001NAPROXEN SODIUM220MGTABLET / ORAL1998-07-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075168-001NAPROXEN SODIUM220MGTABLET / ORAL1998-07-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075168-001NAPROXEN SODIUM220MGTABLET / ORAL1998-07-289b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075168-001NAPROXEN SODIUM220MGTABLET / ORAL1998-07-28a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075168-001NAPROXEN SODIUM220MGTABLET / ORAL1998-07-283f0d92c62455…
2023-05-13 08:27 UTC2023-05A075168-001NAPROXEN SODIUM220MGTABLET / ORAL1998-07-28053a50430f4f…
2023-01-26 05:58 UTC2023-01A075168-001NAPROXEN SODIUM220MGTABLET / ORAL1998-07-283bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075168-001NAPROXEN SODIUM220MGTABLET / ORAL1998-07-283a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075168-001NAPROXEN SODIUM220MGTABLET / ORAL1998-07-28f41ea6bd6efb…

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 Headache Pain CapletsNAPROXEN SODIUMDr.Reddy's Laboratories Inc605ca130-88aa-27d5-330c-6d9c95987f1f2025-07-22WarningsExact identifier
ndc (package): 43598-060-52
ndc (package): 43598-059-52
ndc (product): 43598-060
ndc (product): 43598-059
ndc11 (package): 43598005952
ndc11 (package): 43598006052
spl id: 7f658fac-fde0-3b5d-f8ad-15dcaf71cdad
spl set id: 605ca130-88aa-27d5-330c-6d9c95987f1f

Reported adverse events (FAERS/openFDA)#

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