Indications and uses
temporarily relieves minor aches and pains due to: headache toothache backache menstrual cramps muscular aches the common cold minor pain of arthritis temporarily reduces fever
temporarily relieves minor aches and pains due to: headache toothache backache menstrual cramps muscular aches the common cold minor pain of arthritis temporarily reduces fever
do not take more than directed the smallest effective dose should be used adults and children 12 years and over: take 1 capsule every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 capsule, 2 capsules may be used do not exceed 6 capsules in 24 hours, unless directed by a doctor children under 12 years: ask a doctor
each capsule contains: potassium 20 mg read all warnings and directions before use. Keep carton. store at 20° to 25°C (68° to 77°F) avoid excessive heat above 40°C (104°F)
Active ingredient (in each capsule)
Solubilized ibuprofen equal to 200 mg ibuprofen USP (NSAID)*
(present as the free acid and potassium salt)
*nonsteroidal anti-inflammatory drug
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.
■ you have symptoms of heart problems or stroke:
■ chest pain ■ trouble breathing
■ weakness in one part or side of body
■ slurred speech ■ leg swelling
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.
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
FD & C green no. 3, gelatin, polyethylene glycol, potassium hydroxide, purified water and sorbitol sorbitan solution.
Questions or comments?
call 1-855-274-4122
Distributed by:
AUROHEALTH LLC
279 Princeton-Hightstown Road
East Windsor, NJ 08520
Made in India
Code No.: TS/DRUGS/16/2014
AUROHEALTH
NDC 58602-843-12
Ibuprofen Capsules
200 mg
Pain Reliever/Fever Reducer (NSAID)
40 Liquid Filled
Capsules
I200
Actual Size
READ ANDA KEEP CARTON FOR COMPLETE
WARNING AND INFORMATION
AUROHEALTH
NDC 58602-843-12
Ibuprofen Capsules
200 mg
Pain Reliever/Fever Reducer (NSAID)
40 Liquid Filled
Capsules
I200
Actual Size
READ AND KEEP CARTON FOR COMPLETE
WARNINGS AND INFORMATION
| 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 |
|---|---|---|---|---|---|---|
| 58602-843-12 | Ibuprofen | 40 in 1 BOTTLE | CAPSULE | 40 | 3 | |
| 58602-843-12 | Ibuprofen | 1 in 1 CARTON | CAPSULE | 1 | 3 | |
| 58602-843-18 | Ibuprofen | 1 in 1 CARTON | CAPSULE | 1 | 3 | |
| 58602-843-18 | Ibuprofen | 80 in 1 BOTTLE | CAPSULE | 80 | 3 | |
| 58602-843-30 | Ibuprofen | 160 in 1 BOTTLE | CAPSULE | 160 | 3 | |
| 58602-843-32 | Ibuprofen | 180 in 1 BOTTLE | CAPSULE | 180 | 3 | |
| 58602-843-34 | Ibuprofen | 200 in 1 BOTTLE, PLASTIC | CAPSULE | 200 | 3 | |
| 58602-843-38 | Ibuprofen | 300 in 1 BOTTLE | CAPSULE | 300 | 3 | |
| 58602-843-70 | Ibuprofen | 1 in 1 CARTON | CAPSULE | 1 | 3 | |
| 58602-843-70 | Ibuprofen | 40 in 1 BOTTLE, PLASTIC | CAPSULE | 40 | 3 | |
| 58602-843-72 | Ibuprofen | 80 in 1 BOTTLE, PLASTIC | CAPSULE | 80 | 3 | |
| 58602-843-72 | Ibuprofen | 1 in 1 CARTON | CAPSULE | 1 | 3 | |
| 58602-843-73 | Ibuprofen | 1 in 1 CARTON | CAPSULE | 1 | 3 | |
| 58602-843-73 | Ibuprofen | 20 in 1 BOTTLE | CAPSULE | 20 | 3 | |
| 58602-843-74 | Ibuprofen | 160 in 1 BOTTLE, PLASTIC | CAPSULE | 160 | 3 | |
| 58602-843-75 | Ibuprofen | 300 in 1 BOTTLE, PLASTIC | CAPSULE | 300 | 3 | |
| 58602-843-79 | Ibuprofen | 180 in 1 BOTTLE | CAPSULE | 180 | 3 | |
| 58602-843-79 | Ibuprofen | 2 in 1 CARTON | CAPSULE | 2 | 3 | |
| 58602-843-92 | Ibuprofen | 180 in 1 BOTTLE, PLASTIC | CAPSULE | 180 | 3 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 58602-843 | 58602-843-73, 58602-843-12, 58602-843-18, 58602-843-30, 58602-843-38, 58602-843-32, 58602-843-79, 58602-843-70, 58602-843-72, 58602-843-74, 58602-843-92, 58602-843-34, 58602-843-75 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| IBUPROFEN | WK2XYI10QM | ACTIB |
| FD&C GREEN NO. 3 | 3P3ONR6O1S | IACT |
| GELATIN, UNSPECIFIED | 2G86QN327L | IACT |
| POLYETHYLENE GLYCOL 600 | NL4J9F21N9 | IACT |
| POTASSIUM HYDROXIDE | WZH3C48M4T | IACT |
| WATER | 059QF0KO0R | IACT |
| SORBITOL | 506T60A25R | IACT |
| 1,4-SORBITAN | AV0YTZ4E6J | IACT |
| MANNITOL | 3OWL53L36A | 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 |
|---|---|---|---|---|---|---|---|
| A207753-001 | IBUPROFEN | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2018-06-29 |
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 | A207753-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2018-06-29 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A207753-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2018-06-29 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A207753-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2018-06-29 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207753-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2018-06-29 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A207753-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2018-06-29 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207753-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2018-06-29 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207753-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2018-06-29 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207753-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2018-06-29 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207753-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2018-06-29 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207753-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2018-06-29 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207753-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2018-06-29 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A207753-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2018-06-29 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207753-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2018-06-29 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207753-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2018-06-29 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207753-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2018-06-29 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A207753-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2018-06-29 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A207753-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2018-06-29 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A207753-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2018-06-29 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A207753-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2018-06-29 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A207753-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2018-06-29 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A207753-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2018-06-29 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A207753-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2018-06-29 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A207753-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2018-06-29 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A207753-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2018-06-29 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A207753-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2018-06-29 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A207753-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2018-06-29 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A207753-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2018-06-29 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A207753-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2018-06-29 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A207753-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2018-06-29 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A207753-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2018-06-29 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A207753-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2018-06-29 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A207753-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2018-06-29 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A207753-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2018-06-29 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A207753-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2018-06-29 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A207753-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2018-06-29 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A207753-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2018-06-29 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A207753-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2018-06-29 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A207753-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2018-06-29 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A207753-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2018-06-29 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A207753-001 | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | 2018-06-29 | 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 | IBUPROFEN | Aurohealth LLC | 7779c369-50bf-4cde-9015-ff3fb35e128e | 2022-05-16 | Warnings | 58602-843-92 58602-843-79 58602-843-12 58602-843-34 58602-843-75 58602-843-30 58602-843-74 58602-843-38 58602-843-18 58602-843-70 58602-843-73 58602-843-32 58602-843-72 58602-843 58602084312 58602084370 58602084375 58602084334 58602084332 58602084392 58602084372 58602084374 58602084338 58602084373 58602084330 58602084379 58602084318 4a614548-3e17-4ead-97d2-634996a5b490 7779c369-50bf-4cde-9015-ff3fb35e128e |
Adverse event summaries are temporarily unavailable. Other product information remains available.