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 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) • see end panel for lot number and expiration date
Ibuprofen 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 chances are higher if you
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. (1-800-222-1222)
adults and children 12 years and older |
|
children under 12 years |
|
colloidal silicon dioxide, corn starch, croscarmellose sodium, hypromellose, iron oxide red, iron oxide yellow, microcrystalline cellulose, polyethylene glycol, polysorbate 80, stearic acid, titanium dioxide
1-800-719-9260
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| IBUPROFEN | ACTIVE INGREDIENT | WK2XYI10QM | 1 | |
| IBUPROFEN | ACTIVE MOIETY | WK2XYI10QM | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | 1 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | 1 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | 1 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 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 |
|---|---|
| 10202-647 | 10202-647-62 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| IBUPROFEN | WK2XYI10QM | ACTIB |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| CROSCARMELLOSE SODIUM | M28OL1HH48 | IACT |
| HYPROMELLOSES | 3NXW29V3WO | IACT |
| FERRIC OXIDE RED | 1K09F3G675 | IACT |
| FERRIC OXIDE YELLOW | EX438O2MRT | IACT |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| POLYETHYLENE GLYCOL | 3WJQ0SDW1A | IACT |
| POLYSORBATE 80 | 6OZP39ZG8H | 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 |
|---|---|---|---|---|---|---|
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | SOLUTION, GEL FORMING, EXTENDED RELEASE / OPHTHALMIC | 0.05 %w/w | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | LOTION / TOPICAL | NA | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | POWDER, FOR SUSPENSION / ORAL | 396 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | LOZENGE / ORAL | 120 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | EMULSION / OPHTHALMIC | 26 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | SUSPENSION/ DROPS / OPHTHALMIC | 3 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE / ORAL | 300 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER, FOR SUSPENSION / ORAL | 2553 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, COATED PELLETS / ORAL | 4.4 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | SOLUTION / OPHTHALMIC | 8 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | PELLET / ORAL | 34 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET / BUCCAL | 18 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 1576 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | SUPPOSITORY / VAGINAL | NA | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | TABLET / SUBLINGUAL | 0.08 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | LOTION / TOPICAL | NA | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET, ORALLY DISINTEGRATING / ORAL | 41 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FILM COATED / ORAL | 166 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | GRANULE, FOR SUSPENSION / ORAL | 240 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | GRANULE / ORAL | 29520 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | POWDER / ORAL | 66 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | CONCENTRATE / ORAL | 1 mg/1ml | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | CAPSULE, DELAYED RELEASE / ORAL | 366 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | GRANULE / ORAL | 150 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | SUSPENSION, EXTENDED RELEASE / ORAL | 40 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR | 1 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 21 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, FILM COATED / ORAL | 2000 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | POWDER / RESPIRATORY (INHALATION) | 2 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION, SOLUTION, CONCENTRATE / INTRAVENOUS | 4739 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | SUSPENSION / AURICULAR (OTIC) | 1 %w/v | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | CAPSULE, EXTENDED RELEASE / ORAL | 53 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | DROPS / OPHTHALMIC | 0.05 %w/w | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, DELAYED RELEASE / ORAL | 80 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | SUSPENSION / RESPIRATORY (INHALATION) | 1 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, EXTENDED RELEASE / ORAL | 90 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | TABLET, EXTENDED RELEASE / ORAL | 10 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET / SUBLINGUAL | 43.2 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 0.15 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | CAPSULE, COATED PELLETS / ORAL | 198 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | LOTION / TOPICAL | 0.1 %w/w | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | LIQUID / INTRAVENOUS | 720 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, FOR SUSPENSION / ORAL | 20100 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | FILM, EXTENDED RELEASE / TRANSDERMAL | 49 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET, CHEWABLE / ORAL | 2 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | INSERT, EXTENDED RELEASE / OPHTHALMIC | 0.4 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, DELAYED RELEASE / ORAL | 3.2 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, DELAYED RELEASE / ORAL | 713 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET, FILM COATED / ORAL | 3 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | SUSPENSION, EXTENDED RELEASE / ORAL | 113 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET / BUCCAL | 0.4 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TROCHE / ORAL | 300 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | TABLET / ORAL | 233 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, COATED PELLETS / ORAL | 69 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER / RESPIRATORY (INHALATION) | NA | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | EMULSION / ORAL | NA | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 2 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | EMULSION / TOPICAL | NA | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET / ORAL | 6184 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | AEROSOL, FOAM / VAGINAL | 3 %w/w |
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 |
|---|---|---|---|---|---|---|---|
| A072096-001 | IBUPROFEN | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 |
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 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | c2088c7a36db… | ||
| 2026-09-14 22:38:34 | 2026-08 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A072096-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-12-08 | 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 |
|---|---|---|---|---|---|---|
| 6c3cf259-8da5-4f84-af00-c569ce9bef3f | 66e2a92c-2827-413f-9349-898cc7dc009a | 2019-09-10 | Warnings | 6c3cf259-8da5-4f84-af00-c569ce9bef3f 66e2a92c-2827-413f-9349-898cc7dc009a |
Adverse event summaries are temporarily unavailable. Other product information remains available.