Ibuprofen

Manufacturer
Kinray | Aphena Pharma Solutions - Kentucky, LLC | Marksans Pharma Limited
Effective date
2013-05-30
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 01:40:42

Label at a glance#

ProductIbuprofen
Active ingredientIBUPROFEN
Label structure15 sections

Indications and uses

temporarily relieves minor aches and pain due to: headache toothache backache menstrual cramps the common cold muscular aches minor pain of arthritis 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 caplet every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 caplet, 2 caplets may be used do not exceed 6 caplets in 24 hours, unless directed by a doctor Children under 12 years ask a doctor

Storage and handling

store between 20 o - 25 o C (68 o - 77 o F) see end panel for lot number and expiration date

Label contents#

Full prescribing information#

Active ingredient (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Ibuprofen USP 200 mg (NSAID)**
**nonsteroidal anti-inflammatory drug

Purpose

OTC - PURPOSE SECTION

Pain reliever/ fever reducer

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves minor aches and pain due to:
  • headache
  • toothache
  • backache
  • menstrual cramps
  • the common cold
  • muscular aches
  • minor pain of arthritis
  • 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 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 everyday while using this product
  • take more or for a longer time 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

  • the stomach bleeding warning applies to you
  • you have problems or serious side effects from taking pain relievers or fever reducers
  • you have a history of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, kidney disease or asthma
  • you are taking a diuretic

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • under a doctor's care for any serious condition
  • taking aspirin for heart attack or stroke, because ibuprofen 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
  • 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 the following signs 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
  • 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 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. (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 caplet every 4 to 6 hours while symptoms persist
  • if pain or fever does not respond to 1 caplet, 2 caplets may be used
  • do not exceed 6 caplets in 24 hours, unless directed by a doctor
Children under 12 years
  • ask a doctor

Other Information

STORAGE AND HANDLING SECTION

  • store between 20o- 25oC (68o- 77oF)
  • see end panel for lot number and expiration date

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, croscarmellose sodium, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, titanium dioxide

PRINCIPAL DISPLAY PANEL - 200 mg TABLET CARTON

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Preferred Plus Pharmacy

NDC 61715-061-51

SEE NEW WARNINGS INFORMATION

*Compare to the Active Ingredient in ADVIL®

Ibuprofen TABLETS, USP 200 mg

 Pain Reliever/Fever Reducer (NSAID)

200 COATED CAPLETS†

†CAPSULE-SHAPED TABLETS

Distributed By:

Kinray, Inc., Whitestone, NY 11357

(c) 2013 Kinray Inc., All Rights Reserved, PREFERRED PLUS, PREFERRED PLUS ++++ and the PREFERRED PLUS logo are trademarks and/or registered trademarks of Kinray Inc. All other marks are property of their respective owners.image descriptionimage description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61715-061-512025-05-22C16284748780-19d75b9d1-1821-f424-e053-dadaa90a57ceDrug Facts
61715-061-512020-01-31C16284748780-19d75b9d1-1821-f424-e053-dadaa90a57ceDrug Facts

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QM2
IBUPROFENACTIVE MOIETYWK2XYI10QM2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61U2
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU42
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH482
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G6752
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I302
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1A2
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J9902
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJ2
TALCINACTIVE INGREDIENT7SEV7J4R1U2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP2

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
61715-06161715-061-51

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

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 5 · 273 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii candidate
39 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UPELLET / ORAL1140 mgExact identifier — unii candidate
28 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48POWDER, FOR SUSPENSION / ORAL11.25 mgExact identifier — unii candidate
22 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CAPSULE, DELAYED RELEASE / ORAL40 mgExact identifier — unii candidate
49 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, DELAYED RELEASE / ORAL2210 mgExact identifier — unii candidate
28 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30SUSPENSION / ORAL64 mgExact identifier — unii candidate
39 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET / ORAL232 mgExact identifier — unii candidate
40 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4SOLUTION / ORAL336 mgExact identifier — unii candidate
49 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, DELAYED RELEASE PARTICLES / ORAL170 mgExact identifier — unii candidate
49 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPPOWDER / RESPIRATORY (INHALATION)2 mgExact identifier — unii candidate
40 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, DELAYED RELEASE PARTICLES / ORAL580 mgExact identifier — unii candidate
28 equally ranked IID candidates
POLYVINYL ALCOHOLPOLYVINYL ALCOHOL532B59J990SOLUTION/ DROPS / OPHTHALMIC1.4 %w/vExact identifier — unii candidate
17 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GEL / DENTAL19 %w/wExact identifier — unii candidate
49 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, EXTENDED RELEASE / ORAL90 mgExact identifier — unii candidate
40 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / ORAL6184 mgExact identifier — unii candidate
28 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TAMPON / VAGINALNAExact identifier — unii candidate
49 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, FILM COATED / ORAL166 mgExact identifier — unii candidate
49 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30CAPSULE, DELAYED RELEASE / ORAL1060 mgExact identifier — unii candidate
39 equally ranked IID candidates
POLYVINYL ALCOHOLPOLYVINYL ALCOHOL532B59J990IMPLANT / INTRAVITREAL0.12 mgExact identifier — unii candidate
17 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
40 equally ranked IID candidates
POLYVINYL ALCOHOLPOLYVINYL ALCOHOL532B59J990TABLET, EXTENDED RELEASE / ORAL96 mgExact identifier — unii candidate
17 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPFILM, SOLUBLE / BUCCAL11 mgExact identifier — unii candidate
40 equally ranked IID candidates
TALCTALC7SEV7J4R1UCAPSULE / ORAL729 mgExact identifier — unii candidate
35 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UPOWDER, FOR SOLUTION / ORAL690 mgExact identifier — unii candidate
28 equally ranked IID candidates
POLYVINYL ALCOHOLPOLYVINYL ALCOHOL532B59J990SUSPENSION/ DROPS / OPHTHALMIC1.4 %w/vExact identifier — unii candidate
17 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPGEL / TOPICAL0.06 %w/wExact identifier — unii candidate
40 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
40 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30CREAM / TOPICALNAExact identifier — unii candidate
39 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET / ORAL736 mgExact identifier — unii candidate
22 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPPASTE, DENTIFRICE / DENTAL0.4 %w/wExact identifier — unii candidate
40 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4LOZENGE / ORAL120 mgExact identifier — unii candidate
49 equally ranked IID candidates
STARCH, PREGELATINIZED CORNSTARCH, CORNO8232NY3SJSUSPENSION, EXTENDED RELEASE / ORAL113 mgExact identifier — unii candidate
22 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET / SUBLINGUAL1 mgExact identifier — unii candidate
21 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, CHEWABLE / ORAL127 mgExact identifier — unii candidate
39 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GEL / TOPICAL6 mgExact identifier — unii candidate
49 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
49 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48CAPSULE, EXTENDED RELEASE / ORAL53 mgExact identifier — unii candidate
22 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET / RECTAL32.4 mgExact identifier — unii candidate
35 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, SUGAR COATED / ORALNAExact identifier — unii candidate
35 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, EXTENDED RELEASE / ORAL450 mgExact identifier — unii candidate
49 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61USUSPENSION, EXTENDED RELEASE / ORAL1120 mgExact identifier — unii candidate
28 equally ranked IID candidates
STARCH, PREGELATINIZED CORNSTARCH, CORNO8232NY3SJCAPSULE / ORAL5785 mgExact identifier — unii candidate
22 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPPOWDER, FOR SUSPENSION / ORAL297 mgExact identifier — unii candidate
40 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, DELAYED RELEASE / ORAL349 mgExact identifier — unii candidate
35 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30IMPLANT / INTRAVITREALNAExact identifier — unii candidate
39 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4SUPPOSITORY / RECTAL14 mgExact identifier — unii candidate
49 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, CHEWABLE, EXTENDED RELEASE / ORAL9 mgExact identifier — unii candidate
39 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GEL / NASAL20 mgExact identifier — unii candidate
49 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, EXTENDED RELEASE / ORAL300 mgExact identifier — unii candidate
35 equally ranked IID candidates
TALCTALC7SEV7J4R1UCAPSULE, COATED PELLETS / ORAL14 mgExact identifier — unii candidate
35 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, FOR SUSPENSION / ORAL220 mgExact identifier — unii candidate
49 equally ranked IID candidates
POLYVINYL ALCOHOLPOLYVINYL ALCOHOL532B59J990TABLET, ORALLY DISINTEGRATING / ORAL2 mgExact identifier — unii candidate
17 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / SUBLINGUAL17.5 mgExact identifier — unii candidate
39 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, DELAYED RELEASE / ORAL1190 mgExact identifier — unii candidate
49 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4SUSPENSION / ORAL400 mgExact identifier — unii candidate
49 equally ranked IID candidates
STARCH, PREGELATINIZED CORNSTARCH, CORNO8232NY3SJTABLET, CHEWABLE / ORAL180 mgExact identifier — unii candidate
22 equally ranked IID candidates
TALCTALC7SEV7J4R1USUSPENSION / ORAL234 mgExact identifier — unii candidate
35 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GRANULE, FOR SUSPENSION / ORAL200 mgExact identifier — unii candidate
49 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30GRANULE, FOR SUSPENSION / ORAL14 mgExact identifier — unii candidate
39 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, CHEWABLE, EXTENDED RELEASE / ORAL2 mgExact identifier — unii candidate
49 equally ranked IID candidates

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
A091239-001IBUPROFENIBUPROFEN200MGTABLET / ORAL2011-02-01

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 22:38:342026-08A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-0184e616aacf4f…
2026-08-18 06:07:402026-07A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-01caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-012680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-015bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-01d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-01d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-0179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-01301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-011e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-018072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-015c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-015d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-014b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-0174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-01bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-01782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-0187673890dc5c…
2021-03-12 10:30 UTC2021-03A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-015aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-018869cabd3fbd…
2020-11-12 02:37 UTC2020-11A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-01c0c555d07b60…
2019-12-14 00:12 UTC2019-12A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-013f01610625f2…
2019-09-15 20:21 UTC2019-09A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-01b00525d2431f…
2019-07-19 19:46 UTC2019-07A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-01ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-016a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-011c564ffb4f44…
2023-12-20 04:57 UTC2023-12A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-01ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-01a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-019b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-01a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-013f0d92c62455…
2023-05-13 08:27 UTC2023-05A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-01053a50430f4f…
2023-01-26 05:58 UTC2023-01A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-013bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-013a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A091239-001IBUPROFEN200MGTABLET / ORAL2011-02-01f41ea6bd6efb…

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
54774604-ad04-42ce-85ea-8a3cfe456dd7a74cfe5d-0249-4925-83d3-e8bb233ec05c2025-05-16WarningsExact identifier
spl set id: a74cfe5d-0249-4925-83d3-e8bb233ec05c

Reported adverse events (FAERS/openFDA)#

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