Indications and uses
Temporarily relieves minor aches and pains due to: headache toothache backache menstrual cramps the common cold muscular aches minor pain of arthritis Temporarily reduces fever
Temporarily relieves minor aches and pains due to: headache toothache backache menstrual cramps the common cold muscular aches minor pain of arthritis Temporarily reduces fever
do not use more than directed the smallest effective dose should be used do not take longer than 10 days, unless directed by a doctor (see Warnings) adults and children 12 years and over: 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 take more than 6 tablets in 24 hours unless directed by a doctor children under 12 years: ask a d...
store at controlled room temperature avoid excessive heat 40°C (104°F)
Ibuprofen USP, 200 mg (NSAID)*
*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:
Do not use
Ask a doctor before use if
Ask a doctor or pharmacist before use if you are
When using this product
Stop use and ask a doctor if
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.
carnauba wax, cellulose, corn starch, fumed silica gel, hypromellose, lactose, magnesium stearate, polydextrose, PEG, red iron oxide, sodium starch glycolate, stearic acid, titanium dioxide.
Call 1-800-540-3765
CommUnityCare Federally Qualified Health Centers
IBUPROFEN
200MG
TABS #100
Date:
Name:
Dr.
TAKE AS DIRECTED.
1/1/01
123456
IBUPROFEN 200MG TABS #100 NDC 76413-345-01
Batch:
123456
Lot:
123456
Exp:
1/1/01
HEALTHSTAR
Federal law prohibits the transfer of this drug to any other person than the patient for whom prescribed.

| 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 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 76413-345-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-e48e-f424-e053-dadaa90a57ce | IBUPROFEN 200MG |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 76413-345-01 | Ibuprofen | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | 1 | |
| 76413-345-01 | Ibuprofen | 1 in 1 BOX | TABLET, FILM COATED | 1 | 1 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 57896-941-01 | EA - Each | 57896-941 | 5b56c459-6c50-4d0d-949a-d80fed96596f | 1 | 2013-02-13 |
| 57896-941-05 | EA - Each | 57896-941 | 9cbf532a-95ae-4974-be07-59fdedda1954 | 1 | 2018-06-11 |
| 57896-941-10 | EA - Each | 57896-941 | 874c93e6-c44c-4dd1-9749-cc9ff3e897ed | 1 | 2013-02-13 |
| 57896-941-20 | EA - Each | 57896-941 | 8a5e8df0-2f34-40ef-a71a-b859673857c7 | 1 | 2022-03-09 |
| 57896-941-25 | EA - Each | 57896-941 | e984a636-b76a-4dab-835e-ca5d313d2506 | 1 | 2013-02-13 |
| 57896-941-50 | EA - Each | 57896-941 | 76d64766-ba4b-4c18-ad3a-394ec41a9262 | 1 | 2013-08-02 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 76413-345 | 76413-345-01 |
| 57896-941 |
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 |
|---|---|---|---|---|---|---|---|
| A075010-001 | IBUPROFEN | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 |
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 | A075010-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A075010-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A075010-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075010-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A075010-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075010-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075010-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075010-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075010-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075010-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075010-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A075010-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075010-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075010-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075010-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A075010-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A075010-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A075010-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A075010-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A075010-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A075010-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A075010-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A075010-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A075010-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A075010-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A075010-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A075010-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A075010-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A075010-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A075010-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A075010-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A075010-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A075010-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A075010-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A075010-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A075010-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A075010-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A075010-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A075010-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A075010-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1999-03-01 | 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 | Geri-Care Pharmaceutical Corp | 0744c3ca-4224-4f6a-a033-880949b544fd | 2023-10-30 | Warnings | 57896-941 |
| a4e2cc6b-a212-47b6-9c53-48fff6f1ab0a | 0765c4f9-9691-4acb-aa00-0bf9e63b4726 | 2017-09-12 | Warnings | a4e2cc6b-a212-47b6-9c53-48fff6f1ab0a 0765c4f9-9691-4acb-aa00-0bf9e63b4726 |
Adverse event summaries are temporarily unavailable. Other product information remains available.