Pain and Fever Relief

Manufacturer
Pioneer Life Sciences, LLC
Effective date
2021-05-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:40:26

Label at a glance#

ProductPain and Fever Relief
Active ingredientNAPROXEN SODIUM
Label structure16 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

Adults and children 12 years and over ■ 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 hr period Children under 12 years ■ ask a doctor

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Naproxen sodium 220mg
(naproxen 200mg) (NSAID)*
*nonsteroidal anti-inflammatory drug

Purpose

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
■ 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.

Ask Doctor:

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 DOCTOR/PHARMACIST:

OTC - ASK DOCTOR/PHARMACIST SECTION

■ under a doctor's care for any serious condition
■ taking any other drug

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 of swelling is present in the painful area
■ any new symptoms appear
You may report side effects to FDA at 1-800-FDA-1088

PREGNANCY

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

In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years and over

■ 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 hr period

Children under 12 years

■ ask a doctor

OTHER INFORMATION

OTHER SAFETY INFORMATION

■ each tablet contains: sodium 20mg
■ store at 20 to 250C (68 to 770F). Avoid high
humidity and excessive heat above 400C (1040F).

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Polyvinyl Pyrolidone, Microcrystalline Cellulose, Starch 1500, Sodium Starch Glycolate, Talc, Magnesium Stearate, FD&C Blue #2, Purified Water, Polysorbate 80, Titanium Dioxide, Polyethylene Glycol, Hypromellose

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

When using this product

OTC - WHEN USING SECTION

■ take with food or milk if stomach upset occurs

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
849574naproxen sodium 220 MG Oral TabletPSN1
849574naproxen sodium 220 MG Oral TabletSCD1
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSY1

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72090-003-012023-01-30C16284748780-1f386c649-e604-0266-e053-dadaa90a7c1ac29fec0c-a858-ef95-e053-2995a90a81d8

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72090-003-01Pain and Fever Relief300 in 1 BOTTLETABLET3001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72090-003PAIN AND FEVER RELIEF (NAPROXEN SODIUM) TABLET [PIONEER LIFE SCIENCES, LLC]1Legacy NDC, 1 package rows20210520_c29fec0c-a858-ef95-e053-2995a90a81d8.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72090-00372090-003-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 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
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
c29fe377-2308-9b47-e053-2995a90a3846c29fec0c-a858-ef95-e053-2995a90a81d82021-05-18WarningsExact identifier
spl id: c29fe377-2308-9b47-e053-2995a90a3846
spl set id: c29fec0c-a858-ef95-e053-2995a90a81d8

Reported adverse events (FAERS/openFDA)#

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