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/tablet every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 caplet/tablet, 2 caplets/tablets may be used do not exceed 6 caplets/tablets in 24 hours, unless directed by a doctor children under 12 years ask a doctor
• store between 20° – 25°C (68 – 77°F). • do not use if neck wrap or foil inner seal is broken or missing
Ibuprofen 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
Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin.
Symptoms may include:
■ hives
■ facial swelling
■ asthma (wheezing)
■ shock
■ skin reddening
■rash
■ blisters
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:
■ are age 60 or older
■ have had stomach ulcers or bleeding problems
■ take a blood thinning (anticoagulant) or steroid drug
■ take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
■ have 3 or more alcoholic drinks every day while using this product
■ take more or for a longer time than directed
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.
■ if you have ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducer
■ right before or after heart surgery
■ you have problems or serious side effects from taking pain relievers or fever reducers
■ the stomach bleeding warning applies to you
■ you have a history of stomach problems, such as heartburn
■ you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma or had a stroke
■ you are taking a diuretic
■ taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
■ under a doctor's care for any serious condition
■ taking any other drug
■ take with food or milk if stomach upset occurs
■ 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
■ you have symptoms of heart problems or stroke:
•chest pain
•trouble breathing
•weakness in one part or side of body
•slurred speech
•leg swelling
■ 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 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 right away. (1-800-222-1222)
• do not take more than directed
• the smallest effective dose should be used
| adults and children 12 years and older |
|
| children under 12 years |
|
• store between 20° – 25°C (68 – 77°F).
• do not use if neck wrap or foil inner seal is broken or missing
colloidal silicon dioxide, FD&C Yellow #6, maize starch, Povidone k30, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, sodium starch glycolate, stearic acid, talc titanium dioxide
Call 1-877-770-3183
weekdays 9:00 AM to 4:30 PM EST
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | Code 128 | (01)50362207320912(17)000000(10)XXXXXXX | GTIN-14: 50362207320912 GTIN storage (14 digits): 50362207320912 | 62207-320-91-bulk.jpg |
| Barcode | EAN-13 | 0362207320467 | GTIN-13: 0362207320467 EAN-13: 0362207320467 GTIN-12: 362207320467 UPC-A: 362207320467 GTIN storage (14 digits): 00362207320467 | 62207-320-46-bottle.jpg, 62207-320-46-carton.jpg |
| Barcode | EAN-13 | 0362207321464 | GTIN-13: 0362207321464 EAN-13: 0362207321464 GTIN-12: 362207321464 UPC-A: 362207321464 GTIN storage (14 digits): 00362207321464 | 62207-321-46-bottle.jpg, 62207-321-46-carton.jpg |
| Data code | Code 128 | (00)189038320000000004 | 62207-320-91-bulk.jpg, 62207-321-91-bulk.jpg |
| 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 |
|---|---|
| 62207-320 | 62207-320-41, 62207-320-42, 62207-320-43, 62207-320-46, 62207-320-47, 62207-320-48, 62207-320-49, 62207-320-91, 62207-320-89, 62207-320-90 |
| 62207-321 | 62207-321-41, 62207-321-42, 62207-321-43, 62207-321-46, 62207-321-47, 62207-321-48, 62207-321-49, 62207-321-91, 62207-321-89, 62207-321-90 |
Every source-derived ingredient row is available through these pages.
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 6 | 2025-11-28 | full-release | 2026-06-01 01:18:55 |
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 |
|---|---|---|---|---|---|---|---|
| A202312-001 | IBUPROFEN | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 |
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 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | c2088c7a36db… | ||
| 2026-09-14 22:38:34 | 2026-08 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | 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 |
|---|---|---|---|---|---|---|
| IBUPROFEN | IBUPROFEN | Granules India Limited | 97516b9f-219a-429d-850d-1fe9fd66646b | 2026-06-15 | Warnings | 62207-320-48 62207-320-42 62207-320-91 62207-321-43 62207-320-47 62207-320-43 62207-320-46 62207-320-41 62207-320-49 62207-320-90 62207-321-42 62207-321-41 62207-321-90 62207-320-89 62207-321-47 62207-321-48 62207-321-49 62207-321-46 62207-321-89 62207-321-91 62207-320 62207-321 62207032141 62207032043 62207032049 62207032091 62207032147 62207032042 62207032041 62207032146 62207032190 62207032047 62207032090 62207032142 62207032143 62207032189 62207032191 62207032149 62207032046 62207032048 62207032089 62207032148 5447b3da-b7bc-776b-e063-6394a90a1027 97516b9f-219a-429d-850d-1fe9fd66646b |
Adverse event summaries are temporarily unavailable. Other product information remains available.