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 caplet every 4 to 6 hours while symptoms persist ■ if pain or fever does not respond to 1 caplet, 2 caplets may be used ■ do not exceed 6 caplets in 24 hours, unless directed by a doctor ■ children under 12 years: ask a doctor
read all warnings and directions before use store at 20°-25°C (68°-77°F) avoid high humidity and excessive heat above 40°C (104°F) retain carton for complete product information and warnings
Drug Facts
Ibuprofen 200 mg (NSAID)*
* nonsteroidal anti-inflammatory drug
Pain reliever/fever reducer
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 an NSAID, which may cause severe stomach bleeding. The chances are higher if you
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 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
If pregnant or breast-feeding, 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.
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).
■ do not take more than directed
■ the smallest effective dose should be used
■ adults and children 12 years and over:
■ take 1 caplet every 4 to 6 hours while symptoms persist
■ if pain or fever does not respond to 1 caplet, 2 caplets may be used
■ do not exceed 6 caplets in 24 hours, unless directed by a doctor
■ children under 12 years: ask a doctor
colloidal silicon dioxide, corn starch, FD&C yellow #6, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, talc, titanium dioxide
NDC 63868-570-50
Quality Choice®
†Compare to Active Ingredient in MOTRIN® IB
Ibuprofen
Ibuprofen Tablets, 200mg
Pain Reliever,
Fever Reducer (NSAID_
Actual Size
50 COATED CAPLETS**
**Capsule-Shaped Tablets
| Class | Version | Type | Effective |
|---|---|---|---|
| IBUPROFEN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20191108 |
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0635515985278 | GTIN-13: 0635515985278 EAN-13: 0635515985278 GTIN-12: 635515985278 UPC-A: 635515985278 GTIN storage (14 digits): 00635515985278 | F1112C02QCH_R0.jpg |
| Data code | Data Matrix | F1112C02QCH_R0 | F1112C02QCH_R0.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 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63868-570-01 | Ibuprofen | 100 in 1 BOTTLE, PLASTIC | TABLET, COATED | 100 | 3 | |
| 63868-570-01 | Ibuprofen | 1 in 1 CARTON | TABLET, COATED | 1 | 3 | |
| 63868-570-50 | Ibuprofen | 1 in 1 CARTON | TABLET, COATED | 1 | 3 | |
| 63868-570-50 | Ibuprofen | 50 in 1 BOTTLE, PLASTIC | TABLET, COATED | 50 | 3 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63868-570-01 | EA - Each | 63868-570 | 1463faf7-74de-401c-a86b-568e6a8172da | 1 | 2022-10-06 |
| 63868-570-50 | EA - Each | 63868-570 | 7074b208-0893-453d-a8cf-0e38584a9be3 | 1 | 2022-09-12 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 63868-570 | 63868-570-50, 63868-570-01 |
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 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… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | 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 | CHAIN DRUG MARKETING ASSOCIATION INC | 9c1ded4e-1d3b-1ab6-e053-2995a90aa80d | 2025-12-10 | Warnings | 63868-570-01 63868-570-50 63868-570 63868057001 63868057050 459b3c6b-39d6-a4d6-e063-6394a90a9350 9c1ded4e-1d3b-1ab6-e053-2995a90aa80d |
Adverse event summaries are temporarily unavailable. Other product information remains available.