Indications and uses
temporarily relieves minor aches and pain due to minor pain of arthritis headache toothache backache the common cold menstrual cramps muscular aches temporarily reduces fever
temporarily relieves minor aches and pain due to minor pain of arthritis headache toothache backache the common cold menstrual cramps muscular aches temporarily reduces fever
do not take more than directed the smallest effective dose should be used Adults and children 12 years and older take one tablet every 4 to 6 hours while symptoms persists If pain or fever does not respond to 1 tablet, 2 tablets may be used do not exceed 6 tablets in 24 hours, unless directed by a doctor Children under 12 years ask a doctor
store between 20 o - 25 o C (68 o - 77 o F) avoid high humidity and excessive heat above 40 o C (104 o F) Tamper Evident: do not use if the imprinted seal under the cap is broken or missing
Ibuprofen 200 mg (NSAID)*
*nonsteroidal anti-inflammatory drug
Pain reliever/ fever reducer
temporarily relieves minor aches and pain due to
temporarily reduces fever
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 stomach bleeding. The chance is higher if you
you experience any of the following signs of stomach bleeding
any new symptoms appear
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 right away.
| Adults and children 12 years and older |
|
| Children under 12 years |
|
colloidal silicon dioxide, corn starch, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, FD&C yellow #6 Al. lake, sodium starch glycolate, talc, titanium dioxide and triacetin.
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 61715-018-50 | 2025-05-21 | C162847 | 48780-1 | 9d75b9d0-2f5f-f424-e053-dadaa90a57ce | Drug Facts |
| 61715-018-51 | 2025-05-21 | C162847 | 48780-1 | 9d75b9d0-2f5f-f424-e053-dadaa90a57ce | Drug Facts |
| 61715-018-50 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-2f5f-f424-e053-dadaa90a57ce | Drug Facts |
| 61715-018-51 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-2f5f-f424-e053-dadaa90a57ce | Drug Facts |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| IBUPROFEN | ACTIVE INGREDIENT | WK2XYI10QM | 1 | |
| IBUPROFEN | ACTIVE MOIETY | WK2XYI10QM | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | 1 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 1 | |
| TRIACETIN | INACTIVE INGREDIENT | XHX3C3X673 | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 61715-018 | 61715-018-50, 61715-018-51 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| IBUPROFEN | WK2XYI10QM | ACTIB |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| FD&C YELLOW NO. 6 | H77VEI93A8 | IACT |
| HYPROMELLOSES | 3NXW29V3WO | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| TRIACETIN | XHX3C3X673 | IACT |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | 5856J3G2A2 | IACT |
| TALC | 7SEV7J4R1U | IACT |
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, DELAYED RELEASE / ORAL | 79 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FOR SUSPENSION / ORAL | 220 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | CAPSULE, EXTENDED RELEASE / ORAL | 117 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, DELAYED RELEASE / ORAL | 40 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 615 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | INSERT / VAGINAL | 54.21 mg | ||
| TRIACETIN | TRIACETIN | XHX3C3X673 | CAPSULE, DELAYED RELEASE / ORAL | 5.1 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | CAPSULE, COATED PELLETS / ORAL | 456 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | POWDER, FOR SUSPENSION / ORAL | 4441 mg | ||
| TRIACETIN | TRIACETIN | XHX3C3X673 | TABLET, COATED / ORAL | 1 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | POWDER, FOR SUSPENSION / ORAL | 297 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | CAPSULE, COATED, EXTENDED RELEASE / ORAL | 19 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | POWDER / RESPIRATORY (INHALATION) | 2 mg | ||
| TALC | TALC | 7SEV7J4R1U | GUM, CHEWING / BUCCAL | NA | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 42 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, EXTENDED RELEASE / ORAL | 168 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | LOTION / TOPICAL | 0.1 %w/w | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, ORALLY DISINTEGRATING / ORAL | 68 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | INSERT / VAGINAL | 147 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, FILM COATED / ORAL | 91 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, FOR SOLUTION / ORAL | 1.8 mg/120ml | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, FOR SUSPENSION / ORAL | 200 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, CHEWABLE / ORAL | 1725 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET, EXTENDED RELEASE / ORAL | 1472 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | SUSPENSION / ORAL | 113 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | SYSTEM / TOPICAL | 54 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, FOR SUSPENSION / ORAL | 24 mg | ||
| TRIACETIN | TRIACETIN | XHX3C3X673 | SUSPENSION / ORAL | 7 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, EXTENDED RELEASE / ORAL | 300 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | LOTION / TOPICAL | NA | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CREAM / TOPICAL | 80 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | GRANULE, FOR SUSPENSION / ORAL | 1.7 mg | ||
| TALC | TALC | 7SEV7J4R1U | POWDER, FOR SUSPENSION / ORAL | 735 mg | ||
| TALC | TALC | 7SEV7J4R1U | OINTMENT / TOPICAL | 74.6 %w/w | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET / ORAL | 1127 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | POWDER, FOR SOLUTION / ORAL | 40 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | GRANULE / ORAL | 629 mg | ||
| TALC | TALC | 7SEV7J4R1U | CAPSULE, EXTENDED RELEASE / ORAL | 5119 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GEL / VAGINAL | 8 %w/w | ||
| TALC | TALC | 7SEV7J4R1U | LOZENGE / ORAL | 50 mg | ||
| TALC | TALC | 7SEV7J4R1U | GRANULE, FOR SUSPENSION / ORAL | 296 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | SUSPENSION / ORAL | 11 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | CAPSULE, DELAYED RELEASE / ORAL | 105 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | DROPS / ORAL | NA | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET, COATED / ORAL | 58 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | SUSPENSION, EXTENDED RELEASE / ORAL | 71 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 221 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | CREAM / TOPICAL | 0.1 %w/w | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET / SUBLINGUAL | 409 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | DROPS / ORAL | 0.2 mg/1ml | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | TABLET / SUBLINGUAL | 1 mg | ||
| TRIACETIN | TRIACETIN | XHX3C3X673 | SYSTEM / TRANSDERMAL | 22.1 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TROCHE / ORAL | 300 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | POWDER, FOR SUSPENSION / ORAL | 120 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | FILM / BUCCAL | 3 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | SHAMPOO / TOPICAL | 3 %w/w | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | GUM, CHEWING / BUCCAL | 182 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, DELAYED RELEASE PARTICLES / ORAL | 56 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | SUSPENSION / ORAL | 64 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 |
|---|---|---|---|---|---|---|---|
| A091355-001 | IBUPROFEN | IBUPROFEN | 200MG | TABLET / ORAL | 2011-04-04 |
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 | A091355-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-04-04 | c2088c7a36db… | ||
| 2026-09-14 22:38:34 | 2026-08 | A091355-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-04-04 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A091355-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-04-04 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A091355-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-04-04 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091355-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-04-04 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A091355-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-04-04 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091355-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-04-04 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091355-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-04-04 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091355-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-04-04 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091355-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-04-04 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091355-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-04-04 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091355-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-04-04 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A091355-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-04-04 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091355-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-04-04 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091355-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-04-04 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091355-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-04-04 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A091355-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-04-04 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A091355-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-04-04 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A091355-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-04-04 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A091355-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-04-04 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A091355-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-04-04 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A091355-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-04-04 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A091355-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-04-04 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A091355-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-04-04 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A091355-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-04-04 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A091355-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-04-04 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A091355-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-04-04 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A091355-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-04-04 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A091355-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-04-04 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A091355-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-04-04 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A091355-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-04-04 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A091355-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-04-04 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A091355-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-04-04 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A091355-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-04-04 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A091355-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-04-04 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A091355-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-04-04 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A091355-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-04-04 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A091355-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-04-04 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A091355-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-04-04 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A091355-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-04-04 | 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 |
|---|---|---|---|---|---|---|
| 58a3bd15-d371-4f8f-855b-9fee27ac1645 | 5039de5c-a49a-4b99-9463-25f502e76534 | 2025-05-16 | Warnings | 5039de5c-a49a-4b99-9463-25f502e76534 |
Adverse event summaries are temporarily unavailable. Other product information remains available.