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
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
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
read all warnings and directions before use store between 20-25°C (68-77°F) avoid high humidity and excessive heat above 40°C (104°F)
Drug Facts
Pain reliever/fever reducer
Warnings
Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
If an allergic reaction occurs, stop use and seek medical help right away.
This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you
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.
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.
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)
| adults and children 12 years and older: |
|
| children under 12 years: |
|
colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C red no. 40 aluminum lake, FD&C yellow no. 6 aluminum lake, iron oxides, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, stearic acid, talc, titanium dioxide
Call
1-877-895-3665 (toll-free) or
215-273-8755 (collect) or visit
www.motrin.com
NDC 50580-230-07
Motrin ®IB
Ibuprofen Tablets USP, 200 mg
Pain Reliever / Fever Reducer (NSAID)
Actual Size
24 Coated Caplets**
**Capsule-Shaped Tablets
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 310965 | ibuprofen 200 MG Oral Tablet | PSN | 15 |
| 201126 | Motrin IB 200 MG Oral Tablet | PSN | 15 |
| 201126 | ibuprofen 200 MG Oral Tablet [Motrin] | SBD | 15 |
| 310965 | ibuprofen 200 MG Oral Tablet | SCD | 15 |
| 310965 | ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral Tablet | SY | 15 |
| 201126 | Motrin 200 MG Oral Tablet | SY | 15 |
| Class | Version | Type | Effective |
|---|---|---|---|
| IBUPROFEN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20191108 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 1e73f975-1ce7-705e-2bcf-788b1b5e24ba | Product name | 5 | 20251124 |
| 16cde546-8deb-4df2-a072-dab5566ede95 | Product name | 1 | 20231003 |
| f6d1b8d7-3bd1-4248-eddd-b60565c88015 | Product name | 4 | 20230808 |
| 874f4e63-49d2-5150-5d77-052172814ebd | Product name | 6 | 20230105 |
| 557673c2-8256-b351-e863-4ec71a5a64b0 | Product name | 2 | 20160714 |
| dbc9a339-6215-4e94-9546-57a3b34902ce | Product name | 1 | 20160517 |
| 61c18d4e-b552-5478-8fc0-df38b93e3100 | Product name | 1 | 20140508 |
| 7b2938c9-7eb7-e312-ae90-f54f4240361e | Product name | 1 | 20140508 |
| 997601aa-bb5f-6971-6b90-a21132c12c7b | Product name | 1 | 20140508 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50580-230-01 | Motrin IB | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 15 | |
| 50580-230-01 | Motrin IB | 50 in 1 BOTTLE | TABLET, FILM COATED | 50 | 15 | |
| 50580-230-02 | Motrin IB | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | 15 | |
| 50580-230-02 | Motrin IB | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 15 | |
| 50580-230-03 | Motrin IB | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | 15 | |
| 50580-230-03 | Motrin IB | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 15 | |
| 50580-230-04 | Motrin IB | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 15 | |
| 50580-230-04 | Motrin IB | 225 in 1 BOTTLE | TABLET, FILM COATED | 225 | 15 | |
| 50580-230-05 | Motrin IB | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 15 | |
| 50580-230-05 | Motrin IB | 300 in 1 BOTTLE | TABLET, FILM COATED | 300 | 15 | |
| 50580-230-06 | Motrin IB | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | 15 | |
| 50580-230-06 | Motrin IB | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 15 | |
| 50580-230-07 | Motrin IB | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 15 | |
| 50580-230-07 | Motrin IB | 24 in 1 BOTTLE | TABLET, FILM COATED | 24 | 15 | |
| 50580-230-08 | Motrin IB | 2 in 1 POUCH | TABLET, FILM COATED | 2 | 15 | |
| 50580-230-09 | Motrin IB | 2 in 1 POUCH | TABLET, FILM COATED | 2 | 15 | |
| 50580-230-09 | Motrin IB | 50 in 1 CARTON | TABLET, FILM COATED | 50 | 15 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50580-230-01 | EA - Each | 50580-230 | cc8f08de-0241-475b-a545-b0a755cb1af3 | 1 | 2018-04-19 |
| 50580-230-02 | EA - Each | 50580-230 | b0995e76-9209-4ee6-a3df-52dac7530351 | 1 | 2017-03-06 |
| 50580-230-03 | EA - Each | 50580-230 | 9b1cf925-49e6-4fc4-8bc0-5214192c4f83 | 1 | 2018-05-09 |
| 50580-230-04 | EA - Each | 50580-230 | 7762e942-27c6-4845-ad02-dd99aa0860c0 | 1 | 2024-04-05 |
| 50580-230-06 | EA - Each | 50580-230 | 87541607-8b7c-4ea4-bab2-4e4d92008670 | 1 | 2016-12-07 |
| 50580-230-07 | EA - Each | 50580-230 | ce62c3eb-301b-4537-9973-a909356d6790 | 1 | 2023-12-05 |
| 50580-230-09 | EA - Each | 50580-230 | 2ceccfbe-9a6a-44b6-a475-80dde15586a5 | 1 | 2024-04-05 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 50580-230 | 50580-230-01, 50580-230-02, 50580-230-03, 50580-230-04, 50580-230-05, 50580-230-06, 50580-230-07, 50580-230-08, 50580-230-09 |
Every source-derived ingredient row is available through these pages.
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A077349-001 | IBUPROFEN | IBUPROFEN | 200MG | TABLET / ORAL | RS | 2005-06-21 |
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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A077349-001 | IBUPROFEN | 200MG | TABLET / ORAL | RS | 2005-06-21 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A077349-001 | IBUPROFEN | 200MG | TABLET / ORAL | RS | 2005-06-21 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077349-001 | IBUPROFEN | 200MG | TABLET / ORAL | RS | 2005-06-21 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077349-001 | IBUPROFEN | 200MG | TABLET / ORAL | RS | 2005-06-21 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077349-001 | IBUPROFEN | 200MG | TABLET / ORAL | RS | 2005-06-21 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077349-001 | IBUPROFEN | 200MG | TABLET / ORAL | RS | 2005-06-21 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077349-001 | IBUPROFEN | 200MG | TABLET / ORAL | RS | 2005-06-21 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077349-001 | IBUPROFEN | 200MG | TABLET / ORAL | RS | 2005-06-21 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077349-001 | IBUPROFEN | 200MG | TABLET / ORAL | RS | 2005-06-21 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077349-001 | IBUPROFEN | 200MG | TABLET / ORAL | RS | 2005-06-21 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077349-001 | IBUPROFEN | 200MG | TABLET / ORAL | RS | 2005-06-21 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077349-001 | IBUPROFEN | 200MG | TABLET / ORAL | RS | 2005-06-21 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077349-001 | IBUPROFEN | 200MG | TABLET / ORAL | RS | 2005-06-21 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077349-001 | IBUPROFEN | 200MG | TABLET / ORAL | RS | 2005-06-21 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077349-001 | IBUPROFEN | 200MG | TABLET / ORAL | RS | 2005-06-21 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A077349-001 | IBUPROFEN | 200MG | TABLET / ORAL | RS | 2005-06-21 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077349-001 | IBUPROFEN | 200MG | TABLET / ORAL | RS | 2005-06-21 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A077349-001 | IBUPROFEN | 200MG | TABLET / ORAL | RS | 2005-06-21 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A077349-001 | IBUPROFEN | 200MG | TABLET / ORAL | RS | 2005-06-21 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A077349-001 | IBUPROFEN | 200MG | TABLET / ORAL | RS | 2005-06-21 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A077349-001 | IBUPROFEN | 200MG | TABLET / ORAL | RS | 2005-06-21 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A077349-001 | IBUPROFEN | 200MG | TABLET / ORAL | RS | 2005-06-21 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A077349-001 | IBUPROFEN | 200MG | TABLET / ORAL | RS | 2005-06-21 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A077349-001 | IBUPROFEN | 200MG | TABLET / ORAL | RS | 2005-06-21 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A077349-001 | IBUPROFEN | 200MG | TABLET / ORAL | RS | 2005-06-21 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A077349-001 | IBUPROFEN | 200MG | TABLET / ORAL | RS | 2005-06-21 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A077349-001 | IBUPROFEN | 200MG | TABLET / ORAL | RS | 2005-06-21 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A077349-001 | IBUPROFEN | 200MG | TABLET / ORAL | RS | 2005-06-21 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A077349-001 | IBUPROFEN | 200MG | TABLET / ORAL | RS | 2005-06-21 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A077349-001 | IBUPROFEN | 200MG | TABLET / ORAL | RS | 2005-06-21 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A077349-001 | IBUPROFEN | 200MG | TABLET / ORAL | RS | 2005-06-21 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A077349-001 | IBUPROFEN | 200MG | TABLET / ORAL | RS | 2005-06-21 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A077349-001 | IBUPROFEN | 200MG | TABLET / ORAL | RS | 2005-06-21 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A077349-001 | IBUPROFEN | 200MG | TABLET / ORAL | RS | 2005-06-21 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A077349-001 | IBUPROFEN | 200MG | TABLET / ORAL | RS | 2005-06-21 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A077349-001 | IBUPROFEN | 200MG | TABLET / ORAL | RS | 2005-06-21 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A077349-001 | IBUPROFEN | 200MG | TABLET / ORAL | RS | 2005-06-21 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A077349-001 | IBUPROFEN | 200MG | TABLET / ORAL | RS | 2005-06-21 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A077349-001 | IBUPROFEN | 200MG | TABLET / ORAL | RS | 2005-06-21 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A077349-001 | IBUPROFEN | 200MG | TABLET / ORAL | RS | 2005-06-21 | f41ea6bd6efb… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Motrin IB | IBUPROFEN | Kenvue Brands LLC | d21129f8-4d96-4e36-bc39-a534306dd77e | 2025-10-03 | Warnings | 50580-230-08 50580-230-06 50580-230-04 50580-230-09 50580-230-07 50580-230-03 50580-230-01 50580-230-05 50580-230-02 50580-230 50580023007 50580023003 50580023009 50580023005 50580023002 50580023008 50580023004 50580023001 50580023006 4003a46c-d99c-72f4-e063-6394a90ab2db d21129f8-4d96-4e36-bc39-a534306dd77e |
Adverse event summaries are temporarily unavailable. Other product information remains available.