Boxed warning
Important: Read all product information before using. Keep the box for important information.
Important: Read all product information before using. Keep the box for important information.
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
Other Information store between 20-25 0 C (68-77 0 F) do not use if carton is opened. Do not use if foil inner seal imprinted with "Sealed For Your Safety" is broken or missing
Important: Read all product information before using.
Keep the box for important information.
Active ingredient (in each Orange tablet or caplet**)
Ibuprofen 200 mg (NSAID)*
* nonsteroidal anti-inflammatory drug
**capsule-shaped tablets
Purpose
Pain reliever / fever reducer
Allergy alert: 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.
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding.
The chance is higher if you
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 a doctor before use if
Ask a doctor or pharmacist before use if you are
When using this product
Stop use and ask a doctor if
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)
Directions
| adults and children 12 years and older |
|
| children under 12 years |
|
Other Information
colloidal silicon dioxide, corn starch, D&C yellow no.10 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, talc, titanium dioxide, and triacetin
Call 1-877-244-9825 (toll-free)
Manufactured by:
Strides Pharma Science Limited,
Puducherry - 605 014, India.
PON/DRUGS/16 13 4193
Distributed by:
Strides Pharma Inc.
Bridgewater, NJ 08807
September 2026
| 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 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 59556-855 | 59556-855-42 |
| 59556-856 | 59556-856-42 |
Every source-derived ingredient row is available through these pages.
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 3 | 2024-05-23 | full-release | 2026-06-01 00:12:51 |
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 |
|---|---|---|---|---|---|---|---|
| A091355-001 | IBUPROFEN | IBUPROFEN | 200MG | TABLET / ORAL | 2011-04-04 |
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 | A091355-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-04-04 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A091355-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-04-04 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A091355-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-04-04 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091355-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-04-04 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A091355-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-04-04 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091355-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-04-04 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091355-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-04-04 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091355-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-04-04 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091355-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-04-04 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091355-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-04-04 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091355-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-04-04 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A091355-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-04-04 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091355-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-04-04 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091355-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-04-04 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091355-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-04-04 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A091355-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-04-04 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A091355-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-04-04 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A091355-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-04-04 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A091355-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-04-04 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A091355-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-04-04 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A091355-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-04-04 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A091355-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-04-04 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A091355-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-04-04 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A091355-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-04-04 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A091355-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-04-04 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A091355-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-04-04 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A091355-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-04-04 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A091355-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-04-04 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A091355-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-04-04 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A091355-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-04-04 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A091355-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-04-04 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A091355-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-04-04 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A091355-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-04-04 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A091355-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-04-04 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A091355-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-04-04 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A091355-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-04-04 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A091355-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-04-04 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A091355-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-04-04 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A091355-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-04-04 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A091355-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-04-04 | 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 |
|---|---|---|---|---|---|---|
| Ibuprofen Immediate Release | IBUPROFEN | Strides Pharma Inc | ebcc4da3-d0f6-4e40-99b5-e88310ea4a5b | 2026-09-02 | Boxed warning, Warnings | 59556-856-42 59556-855-42 59556-856 59556-855 59556085642 59556085542 71d99813-1855-484f-a71b-333fcb701a77 ebcc4da3-d0f6-4e40-99b5-e88310ea4a5b |
Adverse event summaries are temporarily unavailable. Other product information remains available.