FDA.reportPublic FDA data

Ibuprofen

Manufacturer
P & L Development, LLC
Effective date
2024-07-30
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:17:12

Label at a glance#

ProductIbuprofen
Active ingredientIBUPROFEN
Label structure10 sections

Indications and uses

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

Dosage and administration

do not take more than directed the smallest effective dose should be used adults and children 12 years and older: take 1 tablet every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 tablet, 2 tablets may be used do not exceed 6 tablets in 24 hours, unless directed by a doctor children under 12 years: ask a doctor

Label contents#

Full prescribing information#

Active ingredient (in each Brown tablet))

OTC - ACTIVE INGREDIENT SECTION

Ibuprofen 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Purposes

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Allergy alert: Ibuprofen 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 an 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.

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

  • you have problems or serious side effects from taking pain relievers or fever reducers
  • 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, or kidney disease asthma, or had a stroke
  • you are taking a diuretic

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
  • under a doctor's care for any serious condition
  • 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:
    • have bloody or black stool
    • feel faint
    • vomit blood
    • have stomach pain that does not get better
  • you have symptoms of heart problems or stroke:
    • chest pain
    • slurred speech
    • leg swelling
    • trouble breathing
    • 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

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use. It is especially important not to use ibuprofen 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.

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
  • adults and children 12 years and older:
    • take 1 tablet every 4 to 6 hours while symptoms persist
    • if pain or fever does not respond to 1 tablet, 2 tablets may be used
    • do not exceed 6 tablets in 24 hours, unless directed by a doctor
  • children under 12 years: ask a doctor

Other information

OTHER SAFETY INFORMATION

  • store at 20-25ºC (68-77ºF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, corn starch, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, iron oxide red, sodium starch glycolate, talc, titanium dioxide, triacetin

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the active ingredient of Advil® Tablets†

SEE NEW WARNINGS

Ibuprofen

Tablets USP, 200 mg

Pain reliever/Fever reducer (NSAID)*

Gluten free

Coated Tablets

*nonsteroidal anti-inflammatory drug

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

†This product is not manufactured or distributed by Haleon Group of Companies, distributor of Advil® Tablets.

Distributed by:

PL Developments

200 Hicks Street

Westbury, NY 11590

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

READYinCASE Ibuprofen 200 mg Brown Tablets
READYinCASE Ibuprofen 200 mg Brown Tablets

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
310965ibuprofen 200 MG Oral TabletPSN3
310965ibuprofen 200 MG Oral TabletSCD3
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
IBUPROFEN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20191108

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015Product name420230808
874f4e63-49d2-5150-5d77-052172814ebdProduct name620230105
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59726-139-50Ibuprofen500 in 1 BOTTLE, PLASTICTABLET, COATED5003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59726-139IBUPROFEN TABLET, COATED [P & L DEVELOPMENT, LLC]3Current NDC, 1 package rows20240815_6d1c9a64-c83c-4b3d-9245-704b94cb367c.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59726-13959726-139-50
59556-857

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
IBUPROFENWK2XYI10QMACTIB
SILICON DIOXIDEETJ7Z6XBU4IACT
STARCH, CORNO8232NY3SJIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
FERRIC OXIDE RED1K09F3G675IACT
SODIUM STARCH GLYCOLATE TYPE A CORNAG9B65PV6BIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
TALC7SEV7J4R1UIACT
TRIACETINXHX3C3X673IACT

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
A079129-001IBUPROFENIBUPROFEN200MGTABLET / ORAL2011-03-28

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 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-28c2088c7a36db…
2026-09-14 22:38:342026-08A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-2884e616aacf4f…
2026-08-18 06:07:402026-07A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-28782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-2887673890dc5c…
2021-03-12 10:30 UTC2021-03A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-285aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-28c0c555d07b60…
2019-12-14 00:12 UTC2019-12A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-283f01610625f2…
2019-09-15 20:21 UTC2019-09A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-28b00525d2431f…
2019-07-19 19:46 UTC2019-07A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-28ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-289b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-28a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-283f0d92c62455…
2023-05-13 08:27 UTC2023-05A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-28053a50430f4f…
2023-01-26 05:58 UTC2023-01A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-283bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A079129-001IBUPROFEN200MGTABLET / ORAL2011-03-283a93d1ddd44b…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IBUPROFEN Immediate ReleaseIBUPROFENStrides Pharma Inca5dd275f-f388-44ec-8297-74430a742d522026-09-02Boxed warning, WarningsExact identifier
ndc (product): 59556-857
IbuprofenIBUPROFENP & L Development, LLC6d1c9a64-c83c-4b3d-9245-704b94cb367c2024-07-30WarningsExact identifier
ndc (package): 59726-139-50
ndc (product): 59726-139
ndc11 (package): 59726013950
spl id: c8b9e254-52a0-423e-81b8-b6f503a443b3
spl set id: 6d1c9a64-c83c-4b3d-9245-704b94cb367c

Reported adverse events (FAERS/openFDA)#

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