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 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
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.
take with food or milk if stomach upset occurs
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.
black iron oxide, FD&C green no 3, gelatin, hypromellose, polyethylene glycol, potassium hydroxide, propylene glycol, sorbitan, sorbitol
COMPARE TO THE ACTIVE INGREDIENT IN ADVIL® LIQUI-GELS®†
Ibuprofen
Capsules, 200 mg
Pain Reliever/Fever Reducer (NSAID)
Softgels
(**Liquid-Filled Capsules)
†This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Advil® Liqui-Gels®.
TAMPER-EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
DISTRIBUTED BY:
MIDWOOD BRANDS, LLC,
500 VOLVO PARKWAY
CHESAPEAKE, VA 23320
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 55319-046-16 | 2022-10-31 | C162847 | 48780-1 | d6a99b39-e4c8-a426-e053-dadaa90af4c2 | DRUG FACTS |
| 55319-046-20 | 2022-10-31 | C162847 | 48780-1 | d6a99b39-e4c8-a426-e053-dadaa90af4c2 | DRUG FACTS |
| 55319-046-16 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-e4c8-a426-e053-dadaa90af4c2 | DRUG FACTS |
| 55319-046-20 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-e4c8-a426-e053-dadaa90af4c2 | DRUG FACTS |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 55319-046 | 55319-046-16, 55319-046-20 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| IBUPROFEN | WK2XYI10QM | ACTIB |
| FD&C GREEN NO. 3 | 3P3ONR6O1S | IACT |
| GELATIN | 2G86QN327L | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| POTASSIUM HYDROXIDE | WZH3C48M4T | IACT |
| SORBITOL | 506T60A25R | IACT |
| SORBITAN | 6O92ICV9RU | IACT |
| HYPROMELLOSE, UNSPECIFIED | 3NXW29V3WO | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | 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 |
|---|---|---|---|---|---|---|
| 6403a89b-ae4d-42e5-9a5c-d51613f0f42a | ff13ff8f-ef17-4d08-bd44-058a080c8c61 | 2022-10-31 | Warnings | 6403a89b-ae4d-42e5-9a5c-d51613f0f42a ff13ff8f-ef17-4d08-bd44-058a080c8c61 |
Adverse event summaries are temporarily unavailable. Other product information remains available.