FDA.reportPublic FDA data

IBUPROFEN

Manufacturer
TARGET CORPORATION | TIME CAP LABORATORIES INC | MARKSANS PHARMA LTD
Effective date
2024-01-03
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:06:33

Label at a glance#

ProductIBUPROFEN
Active ingredientIBUPROFEN
Label structure9 sections

Storage and handling

Other information read all warnings and directions before use store at 20-25ºC (68-77ºF)

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each caplet)

Ibuprofen 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

OTC - PURPOSE SECTION

Purposes

Pain reliever/fever reducer

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

Warnings

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 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

OTC - DO NOT USE SECTION

Do not use

  • if you have ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducer
  • right before or after heart surgery

OTC - ASK DOCTOR SECTION

Ask a doctor before use if

  • you have problems or serious side effects from taking pain relievers or fever reducers
  • 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

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are

  • 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

OTC - WHEN USING SECTION

When using this product

  • take with food or milk if stomach upset occurs

OTC - WHEN USING 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
redness or swelling is present in the painful area
any new symptoms appear

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, 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.

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).

STORAGE AND HANDLING SECTION

Other information

  • read all warnings and directions before use
  • store at 20-25ºC (68-77ºF)

DOSAGE & ADMINISTRATION SECTION

Directions

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

INACTIVE INGREDIENT SECTION

Inactive ingredients colloidal silicon dioxide, croscarmellose sodium, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, titanium dioxide

OTC - QUESTIONS SECTION

Questions or comments? Call 1-877-290-4008

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

612R-TG-225s-label612R-TG-225s-label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
310965ibuprofen 200 MG Oral TabletPSN5
310965ibuprofen 200 MG Oral TabletSCD5
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY5

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
11673-993-01IBUPROFEN100 in 1 BOTTLETABLET, COATED1005
11673-993-26IBUPROFEN225 in 1 BOTTLETABLET, COATED2255

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11673-993IBUPROFEN TABLET, COATED [TARGET CORPORATION]5Current NDC, Legacy NDC, 2 package rows20240104_8e872c8d-28e2-cd49-e053-2995a90a469f.zip

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
11673-99311673-993-01, 11673-993-26

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
CROSCARMELLOSE SODIUMM28OL1HH48IACT
FD&C YELLOW NO. 6H77VEI93A8IACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990IACT
STARCH, CORNO8232NY3SJIACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
IBUPROFENWK2XYI10QMACTIB

Source Document#

Source XML · Source PDF

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
A091237-001IBUPROFENIBUPROFEN200MGTABLET / ORAL2011-02-08

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 22:38:342026-08A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-0884e616aacf4f…
2026-08-18 06:07:402026-07A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-08caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-088072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-085c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-085d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-084b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-0874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-08bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-08782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-0887673890dc5c…
2021-03-12 10:30 UTC2021-03A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-085aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-088869cabd3fbd…
2020-11-12 02:37 UTC2020-11A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-08c0c555d07b60…
2019-12-14 00:12 UTC2019-12A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-083f01610625f2…
2019-09-15 20:21 UTC2019-09A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-08b00525d2431f…
2019-07-19 19:46 UTC2019-07A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-08ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-086a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-081c564ffb4f44…
2023-12-20 04:57 UTC2023-12A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-08ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-08a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-089b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-08a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-083f0d92c62455…
2023-05-13 08:27 UTC2023-05A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-08053a50430f4f…
2023-01-26 05:58 UTC2023-01A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-083bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-083a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A091237-001IBUPROFEN200MGTABLET / ORAL2011-02-08f41ea6bd6efb…

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
IBUPROFENIBUPROFENTARGET CORPORATION8e872c8d-28e2-cd49-e053-2995a90a469f2024-01-03WarningsExact identifier
ndc (package): 11673-993-26
ndc (package): 11673-993-01
ndc (product): 11673-993
ndc11 (package): 11673099326
ndc11 (package): 11673099301
spl id: 0e07c84c-691d-97b3-e063-6394a90aa81d
spl set id: 8e872c8d-28e2-cd49-e053-2995a90a469f

Reported adverse events (FAERS/openFDA)#

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