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
SEE NEW WARNINGS
IBUPROFEN
pain reliever/fever reducer (NSAID)
COMPARE TO THE ACTIVE INGREDIENT IN ADVIL*
100 Tablets
200 mg each
Tamper Evident:
Do not use if imprinted seal under cap is missing or broken.
| 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 |
|---|---|---|---|---|---|
| 42254-315-20 | 2019-09-24 | C162847 | 48780-1 | 9350213a-3c80-c013-e053-90daa90a1393 | Ibuprofen |
| 42254-315-28 | 2019-09-24 | C162847 | 48780-1 | 9350213a-3c80-c013-e053-90daa90a1393 | Ibuprofen |
| 42254-315-30 | 2019-09-24 | C162847 | 48780-1 | 9350213a-3c80-c013-e053-90daa90a1393 | Ibuprofen |
| 42254-315-40 | 2019-09-24 | C162847 | 48780-1 | 9350213a-3c80-c013-e053-90daa90a1393 | Ibuprofen |
| 42254-315-50 | 2019-09-24 | C162847 | 48780-1 | 9350213a-3c80-c013-e053-90daa90a1393 | Ibuprofen |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 42254-315-20 | Ibuprofen | 20 in 1 BOTTLE | TABLET, FILM COATED | 20 | 1 | |
| 42254-315-28 | Ibuprofen | 28 in 1 BOTTLE | TABLET, FILM COATED | 28 | 1 | |
| 42254-315-30 | Ibuprofen | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 1 | |
| 42254-315-40 | Ibuprofen | 40 in 1 BOTTLE | TABLET, FILM COATED | 40 | 1 | |
| 42254-315-50 | Ibuprofen | 50 in 1 BOTTLE | TABLET, FILM COATED | 50 | 1 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 42254-315-20 | EA - Each | 42254-315 | f7ba684d-fd5a-44b9-be81-e9f6424e9803 | 1 | 2013-03-03 |
| 42254-315-28 | EA - Each | 42254-315 | 6926276e-94ca-4d13-8f2c-2d8253d7deee | 1 | 2013-03-03 |
| 42254-315-30 | EA - Each | 42254-315 | 500cec68-1037-4801-b078-ed269dacf4b5 | 1 | 2013-03-03 |
| 42254-315-40 | EA - Each | 42254-315 | 6c406f73-1f74-4329-b0d1-29cb51475283 | 1 | 2013-03-03 |
| 42254-315-50 | EA - Each | 42254-315 | 1faa4c3f-4f12-4c10-ada3-c0fc262815fd | 1 | 2013-03-03 |
| 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 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| IBUPROFEN | ACTIVE INGREDIENT | WK2XYI10QM | 1 | |
| IBUPROFEN | ACTIVE MOIETY | WK2XYI10QM | 1 | |
| CARNAUBA WAX | INACTIVE INGREDIENT | R12CBM0EIZ | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | 1 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | 1 | |
| LACTOSE | INACTIVE INGREDIENT | J2B2A4N98G | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | 1 | |
| POLYDEXTROSE | INACTIVE INGREDIENT | VH2XOU12IE | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | 1 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 42254-315 | 42254-315-20, 42254-315-28, 42254-315-30, 42254-315-40, 42254-315-50 |
| 57896-941 |
Every source-derived ingredient row is available through these pages.
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET, FILM COATED / ORAL | 582 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, FILM COATED / ORAL | 96 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, FILM COATED / ORAL | 2000 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET, FILM COATED / ORAL | 3 mg | ||
| POLYDEXTROSE | POLYDEXTROSE | VH2XOU12IE | TABLET, FILM COATED / ORAL | 18 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, FILM COATED / ORAL | 36 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FILM COATED / ORAL | 166 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | TABLET, FILM COATED / ORAL | 590 mg | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | TABLET, FILM COATED / ORAL | 1 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, FILM COATED / ORAL | 992 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, FILM COATED / ORAL | 176 mg |
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 |
| c9d22362-e442-4690-9aa9-9d34aef09504 | c9d22362-e442-4690-9aa9-9d34aef09504 | 2012-10-16 | Warnings | c9d22362-e442-4690-9aa9-9d34aef09504 c9d22362-e442-4690-9aa9-9d34aef09504 |
Adverse event summaries are temporarily unavailable. Other product information remains available.