Indications and uses
temporarily relieves minor aches and pains due to: headache muscular aches toothache minor pain of arthritis backache the common cold menstrual cramps temporarily reduces fever
temporarily relieves minor aches and pains due to: headache muscular aches toothache minor pain of arthritis 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
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:
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
1-877-753-3935 Monday-Friday 9AM-5PM EST
COMPARE TO THE ACTIVE INGREDIENT OF ADVIL® CAPLETS†
SEE NEW WARNINGS
ibuprofen
Tablets USP, 200 mg
Pain reliever/fever reducer (NSAID)
COATED CAPLETS**
(**CAPSULE-SHAPED TABLETS)
†This product is not manufactured or distributed by Pfizer Consumer Healthcare,distributor of Advil® Caplets.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
DISTRIBUTED BY:
MIDWOOD BRANDS, LLC
10611 MONROE RD., MATTHEWS, NC 28105
| 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 |
|---|---|
| 55319-186 | 55319-186-50, 55319-186-25, 55319-186-01 |
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 |
|---|---|---|---|---|---|---|
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, DELAYED RELEASE PARTICLES / ORAL | 170 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, DELAYED RELEASE / ORAL | 2210 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | PELLET / ORAL | 34 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, CHEWABLE / ORAL | 216 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | GRANULE, FOR SUSPENSION / ORAL | 278 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | FILM, EXTENDED RELEASE / TRANSDERMAL | 49 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FOR SUSPENSION / ORAL | 220 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | SOLUTION / TOPICAL | NA | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET, EXTENDED RELEASE / ORAL | 7 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GEL / TOPICAL | 6 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | POWDER, FOR SUSPENSION / ORAL | 34 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, FILM COATED / ORAL | 36 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | INSERT / VAGINAL | 8 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, DELAYED RELEASE PARTICLES / ORAL | 64 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | PASTE / DENTAL | 34 %w/w | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET, CHEWABLE / ORAL | 11.8 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | SYSTEM / TOPICAL | 54 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET / BUCCAL | 16.6 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 11 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | DROPS / ORAL | NA | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, COATED / ORAL | 42.4 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET, FILM COATED / ORAL | 3 mg | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 140 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, EXTENDED RELEASE / ORAL | 67 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, EXTENDED RELEASE / ORAL | 184 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, COATED / ORAL | 49 mg | ||
| POLYDEXTROSE | POLYDEXTROSE | VH2XOU12IE | TABLET, EXTENDED RELEASE / ORAL | 22 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GEL / NASAL | 20 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET / ORAL | 232 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET, FILM COATED / ORAL | 582 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, ORALLY DISINTEGRATING / ORAL | 10 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 615 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | SUSPENSION / ORAL | 150 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | INSERT, EXTENDED RELEASE / OPHTHALMIC | 0.4 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 21 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | INSERT / VAGINAL | 147 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | CAPSULE, COATED / ORAL | 0.12 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, FILM COATED / ORAL | 992 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, EXTENDED RELEASE / ORAL | 392 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | CAPSULE, DELAYED RELEASE / ORAL | 14 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, DELAYED RELEASE PARTICLES / ORAL | 580 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, COATED / ORAL | 3 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | DROPS / ORAL | NA | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | POWDER, FOR SUSPENSION / ORAL | 297 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | GRANULE / ORAL | 150 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, DELAYED RELEASE / ORAL | 40 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | SYSTEM / TOPICAL | 420 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET, COATED / ORAL | 58 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET, ORALLY DISINTEGRATING / ORAL | 41 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET / ORAL | 736 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | GRANULE / ORAL | 45 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GEL / DENTAL | 19 %w/w | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | SUSPENSION / ORAL | 1600 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 336 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | SUSPENSION, EXTENDED RELEASE / ORAL | 113 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET / SUBLINGUAL | 9 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | GRANULE, FOR SUSPENSION / ORAL | 1.7 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, COATED / ORAL | 920 mg | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | CAPSULE / ORAL | NA |
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 |
|---|---|---|---|---|---|---|
| 8ca729b7-468f-4329-ac93-e9ce43a40db3 | c07e53a4-33c6-4668-ace6-637ce1f6ffca | 2021-10-20 | Warnings | 8ca729b7-468f-4329-ac93-e9ce43a40db3 c07e53a4-33c6-4668-ace6-637ce1f6ffca |
Adverse event summaries are temporarily unavailable. Other product information remains available.