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 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 exceed 6 tablets in 24 hours, unless directed by a doctor children under 12 years: ask a doctor
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 an 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:
Heart attack and stroke warning: 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.
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)
carnauba wax, croscarmellose sodium, hypromellose, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch, red iron oxide, silicon dioxide, stearic acid, titanium dioxide
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Compare to the active ingredient in Advil® Tablets†
Ibuprofen
Tablets USP, 200 mg
Pain Reliever/Fever Reducer (NSAID)
Coated tablets
†This product is not manufactured or distributed by Pfizer Consumer Healthcare, distributor of Advil® Tablets.
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION
Distributed by:
PL Developments
200 Hicks Street
Westbury, NY 11590
| 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 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | 1 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | 1 | |
| POLYDEXTROSE | INACTIVE INGREDIENT | VH2XOU12IE | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | 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 |
|---|---|
| 59726-235 | 59726-235-40, 59726-235-24 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| IBUPROFEN | WK2XYI10QM | ACTIB |
| CARNAUBA WAX | R12CBM0EIZ | IACT |
| CROSCARMELLOSE SODIUM | M28OL1HH48 | IACT |
| HYPROMELLOSES | 3NXW29V3WO | IACT |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| POLYDEXTROSE | VH2XOU12IE | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| FERRIC OXIDE RED | 1K09F3G675 | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | 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 |
|---|---|---|---|---|---|---|
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | DROPS / ORAL | NA | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | CAPSULE, EXTENDED RELEASE / ORAL | 53 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, DELAYED RELEASE / ORAL | 80 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | FILM, SOLUBLE / ORAL | 2 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, FILM COATED / ORAL | 36 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, COATED / ORAL | 256 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET, FILM COATED / ORAL | 582 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GEL / NASAL | 20 mg | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | GUM, CHEWING / BUCCAL | 10 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | FILM, EXTENDED RELEASE / TRANSDERMAL | 49 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | CAPSULE, COATED, EXTENDED RELEASE / ORAL | 19 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | INJECTION / INTRAMUSCULAR | 1 %w/v | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 3.6 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GEL / VAGINAL | 8 %w/w | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | POWDER, FOR SUSPENSION / ORAL | 11.25 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | EMULSION / ORAL | NA | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET, DELAYED RELEASE / ORAL | 79 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | EMULSION / TOPICAL | NA | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 0.15 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | GEL / TOPICAL | 0.06 %w/w | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | POWDER, FOR SUSPENSION / ORAL | 1203 mg/5ml | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, LIQUID FILLED / ORAL | 12 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, COATED / ORAL | 920 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET, ORALLY DISINTEGRATING / ORAL | 2 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | CAPSULE, COATED PELLETS / ORAL | 3.32 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | CAPSULE / ORAL | 257 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | POWDER / RESPIRATORY (INHALATION) | 2 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IMPLANT / INTRAVITREAL | 1.66 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | CONCENTRATE / ORAL | NA | ||
| POLYDEXTROSE | POLYDEXTROSE | VH2XOU12IE | TABLET / ORAL | 20 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | CAPSULE / ORAL | 2169 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, DELAYED RELEASE / ORAL | 55 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | CAPSULE, COATED PELLETS / ORAL | 2 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | LOZENGE / ORAL | 120 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | CAPSULE, EXTENDED RELEASE / ORAL | 119.7 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET / ORAL | 232 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET / BUCCAL | 3 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | SUSPENSION, EXTENDED RELEASE / ORAL | 70 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | SOLUTION / ORAL | 336 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | CAPSULE, EXTENDED RELEASE / ORAL | 5 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, CHEWABLE / ORAL | 180 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | SUSPENSION / ORAL | 305 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET, COATED / ORAL | 1 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | CAPSULE, EXTENDED RELEASE / ORAL | 64 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | POWDER, FOR SUSPENSION / ORAL | 34 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET / SUBLINGUAL | 10 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET, EXTENDED RELEASE / ORAL | 7 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | FILM / BUCCAL | 3 mg | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | CAPSULE / ORAL | NA | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET, ORALLY DISINTEGRATING / ORAL | 41 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FOR SUSPENSION / ORAL | 220 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, DELAYED RELEASE / ORAL | 2210 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | GRANULE, FOR SUSPENSION / ORAL | 1.7 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET / ORAL | 6184 mg | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | TABLET, EXTENDED RELEASE / ORAL | 2150 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | GRANULE, DELAYED RELEASE / ORAL | 789.6 mg | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | OINTMENT / TOPICAL | NA | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | CAPSULE, COATED PELLETS / ORAL | 456 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | INSERT, EXTENDED RELEASE / OPHTHALMIC | 0.4 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 |
|---|---|---|---|---|---|---|---|
| A076460-001 | IBUPROFEN | IBUPROFEN | 200MG | TABLET / ORAL | 2003-11-26 |
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 | A076460-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2003-11-26 | c2088c7a36db… | ||
| 2026-09-14 22:38:34 | 2026-08 | A076460-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2003-11-26 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076460-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2003-11-26 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076460-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2003-11-26 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076460-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2003-11-26 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076460-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2003-11-26 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076460-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2003-11-26 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076460-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2003-11-26 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076460-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2003-11-26 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076460-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2003-11-26 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076460-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2003-11-26 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076460-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2003-11-26 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A076460-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2003-11-26 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076460-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2003-11-26 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076460-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2003-11-26 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076460-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2003-11-26 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A076460-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2003-11-26 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076460-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2003-11-26 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A076460-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2003-11-26 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A076460-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2003-11-26 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A076460-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2003-11-26 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A076460-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2003-11-26 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A076460-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2003-11-26 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A076460-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2003-11-26 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A076460-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2003-11-26 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A076460-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2003-11-26 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A076460-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2003-11-26 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A076460-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2003-11-26 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A076460-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2003-11-26 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A076460-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2003-11-26 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A076460-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2003-11-26 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A076460-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2003-11-26 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A076460-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2003-11-26 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A076460-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2003-11-26 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A076460-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2003-11-26 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A076460-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2003-11-26 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A076460-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2003-11-26 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A076460-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2003-11-26 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A076460-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2003-11-26 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A076460-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2003-11-26 | 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 |
|---|---|---|---|---|---|---|
| 8d09357f-779f-4ac2-9332-91a6ed918ee2 | 7c433321-6b20-40d7-bbb7-e06df350c7f1 | 2019-12-06 | Warnings | 8d09357f-779f-4ac2-9332-91a6ed918ee2 7c433321-6b20-40d7-bbb7-e06df350c7f1 |
Adverse event summaries are temporarily unavailable. Other product information remains available.