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 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
■ Store between 20-25°C (68-77°F) ■ tamper evident: do not use if imprinted safety seal under cap is broken or missing; do not use if seal is open or missing in bulk pack.
Ibuprofen, USP 200 mg (NSAID)*
____________________________________
* nonsteroidal anti-inflammatory drug
Pain reliever / fever reducer
■ 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
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 a non-steroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding.
The chance is higher if you:
■ 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
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.
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
| 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 |
■ Store between 20-25°C (68-77°F)
■ tamper evident: do not use if imprinted safety seal under cap is broken or missing;
do not use if seal is open or missing in bulk pack.
colloidal silicon dioxide, corn starch, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, red iron oxide, sodium starch glycolate, titanium dioxide, triacetin and talc
Call 1-732-465-0700: weekdays 8.00 AM to 8.00 PM
Manufactured by:
Strides Pharma Science Limited
Puducherry - 605014, India
See New Warnings Information
Ibuprofen Tablets USP 200 mg
Pain Reliever / Fever Reducer (NSAID)
- 30000 coated tablets
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 55629-095 | 55629-095-01 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| IBUPROFEN | WK2XYI10QM | ACTIB |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| HYPROMELLOSE 2208 (100 MPA.S) | B1QE5P712K | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | 5856J3G2A2 | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| TRIACETIN | XHX3C3X673 | IACT |
| TALC | 7SEV7J4R1U | IACT |
| FERRIC OXIDE RED | 1K09F3G675 | IACT |
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 |
|---|---|---|---|---|---|---|---|
| A079129-001 | IBUPROFEN | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | c2088c7a36db… | ||
| 2026-09-14 22:38:34 | 2026-08 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | 3a93d1ddd44b… |
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 |
|---|---|---|---|---|---|---|
| f9b136cf-cddf-4831-bf8a-bf7e4a3b20a7 | aafdafad-2587-4d62-9705-c68beab87ba6 | 2019-09-11 | Warnings | f9b136cf-cddf-4831-bf8a-bf7e4a3b20a7 aafdafad-2587-4d62-9705-c68beab87ba6 |
Adverse event summaries are temporarily unavailable. Other product information remains available.