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:
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)
colloidal silicon dioxide, corn starch, hypromellose, iron oxide red, lactose monohydrate, povidone (K-30), sodium starch glycolate, stearic acid, titanium dioxide, triacetin
Call toll free 1-888-423-0139
CAPLETS
Ibuprofen Tablets USP, 200 mg
• Pain Reliever / Fever Reducer (NSAID)
COMPARE TO ADVIL® active ingredient**
COATED CAPLETS†
(†CAPSULE-SHAPED TABLETS)
**This product is not manufactured or distributed by Pfizer Consumer Healthcare, owner of the registered trademark Advil®.
DISTRIBUTED BY TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL 60007
Product of India
DO NOT USE IF TAMPER-EVIDENT SEAL UNDER BOTTLE CAP IMPRINTED WITH "SEALED FOR YOUR PROTECTION" IS BROKEN OR MISSING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| IBUPROFEN | ACTIVE INGREDIENT | WK2XYI10QM | 2 | |
| IBUPROFEN | ACTIVE MOIETY | WK2XYI10QM | 2 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | 2 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | 2 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | 2 | |
| POVIDONE K30 | INACTIVE INGREDIENT | U725QWY32X | 2 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 2 | |
| SODIUM STARCH GLYCOLATE TYPE A CORN | INACTIVE INGREDIENT | AG9B65PV6B | 2 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | 2 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 2 | |
| TRIACETIN | INACTIVE INGREDIENT | XHX3C3X673 | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 36800-248 | 36800-248-78, 36800-248-71 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| IBUPROFEN | WK2XYI10QM | ACTIB |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| HYPROMELLOSES | 3NXW29V3WO | IACT |
| FERRIC OXIDE RED | 1K09F3G675 | IACT |
| LACTOSE MONOHYDRATE | EWQ57Q8I5X | IACT |
| POVIDONE K30 | U725QWY32X | IACT |
| SODIUM STARCH GLYCOLATE TYPE A CORN | AG9B65PV6B | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| TRIACETIN | XHX3C3X673 | 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 |
|---|---|---|---|---|---|---|
| TRIACETIN | TRIACETIN | XHX3C3X673 | POWDER, FOR SUSPENSION / ORAL | 12 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, ORALLY DISINTEGRATING / ORAL | 68 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | SUSPENSION / OPHTHALMIC | 14 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | SUSPENSION, EXTENDED RELEASE / ORAL | 113 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | TABLET, DELAYED RELEASE PARTICLES / ORAL | 70 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | TABLET, FOR SUSPENSION / ORAL | 2794 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, DELAYED RELEASE / ORAL | 40 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | INSERT, EXTENDED RELEASE / OPHTHALMIC | 0.4 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | POWDER, FOR SOLUTION / ORAL | 2832 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, DELAYED RELEASE PARTICLES / ORAL | 170 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVERNOUS | 174 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | PASTILLE / ORAL | NA | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | CAPSULE, EXTENDED RELEASE / ORAL | 120 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, CHEWABLE / ORAL | 254 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | CREAM / TOPICAL | 190 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GEL / DENTAL | 19 %w/w | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | SHAMPOO, SUSPENSION / TOPICAL | 3 %w/v | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | LOZENGE / ORAL | 120 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE / ORAL | 300 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET / SUBLINGUAL | 9 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | CAPSULE, COATED PELLETS / ORAL | 2 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS | 107 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GEL / TOPICAL | 6 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | FILM / SUBLINGUAL | 7 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, FOR SOLUTION / ORAL | 1.8 mg/120ml | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | CONCENTRATE / ORAL | NA | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | GRANULE, FOR SUSPENSION / ORAL | 143 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | TABLET, COATED / ORAL | 160 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | SUSPENSION / ORAL | 900 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET / BUCCAL | 6 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | CAPSULE, COATED PELLETS / ORAL | 265 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | CAPSULE, EXTENDED RELEASE / ORAL | 5364 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | GRANULE / ORAL | 8946 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 11 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CREAM / VAGINAL | 51 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | CAPSULE, DELAYED RELEASE / ORAL | 227 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | CAPSULE / ORAL | 1488 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | FILM, SOLUBLE / ORAL | 2 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | SUSPENSION / ORAL | 305 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, EXTENDED RELEASE / ORAL | 450 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE / RESPIRATORY (INHALATION) | NA | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | INSERT / VAGINAL | 147 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | PASTE, DENTIFRICE / DENTAL | 0.4 %w/w | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | CAPSULE, DELAYED RELEASE / ORAL | 105 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET / BUCCAL | 16.6 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 120 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, FILM COATED / ORAL | 176 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | FILM, EXTENDED RELEASE / TRANSDERMAL | 49 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET, ORALLY DISINTEGRATING / ORAL | 41 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | OINTMENT / TOPICAL | 15 %w/w | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | CAPSULE, LIQUID FILLED / ORAL | 101 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | SUSPENSION / ORAL | 400 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 2 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | CAPSULE, COATED PELLETS / ORAL | 3.32 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | FILM / BUCCAL | 3 mg | ||
| TRIACETIN | TRIACETIN | XHX3C3X673 | CONCENTRATE / ORAL | 250 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET / BUCCAL | 0.4 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | FILM, SOLUBLE / BUCCAL | 11 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | 750 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, DELAYED RELEASE / ORAL | 1190 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 |
|---|---|---|---|---|---|---|---|
| A079174-001 | IBUPROFEN | IBUPROFEN | 200MG | TABLET / ORAL | 2010-12-10 |
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 | A079174-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2010-12-10 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A079174-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2010-12-10 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A079174-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2010-12-10 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079174-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2010-12-10 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A079174-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2010-12-10 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079174-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2010-12-10 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079174-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2010-12-10 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079174-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2010-12-10 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A079174-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2010-12-10 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A079174-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2010-12-10 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A079174-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2010-12-10 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A079174-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2010-12-10 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A079174-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2010-12-10 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A079174-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2010-12-10 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A079174-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2010-12-10 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A079174-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2010-12-10 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A079174-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2010-12-10 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A079174-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2010-12-10 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A079174-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2010-12-10 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A079174-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2010-12-10 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A079174-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2010-12-10 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A079174-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2010-12-10 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A079174-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2010-12-10 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A079174-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2010-12-10 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A079174-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2010-12-10 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A079174-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2010-12-10 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A079174-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2010-12-10 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A079174-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2010-12-10 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A079174-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2010-12-10 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A079174-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2010-12-10 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A079174-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2010-12-10 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A079174-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2010-12-10 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A079174-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2010-12-10 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A079174-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2010-12-10 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A079174-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2010-12-10 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A079174-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2010-12-10 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A079174-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2010-12-10 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A079174-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2010-12-10 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A079174-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2010-12-10 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A079174-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2010-12-10 | 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 |
|---|---|---|---|---|---|---|
| d8718d1f-895d-4cac-a4f3-00425bcd39a8 | ccac836e-ea05-4d49-a80f-d7d7d6e35bf7 | 2019-08-07 | Warnings | d8718d1f-895d-4cac-a4f3-00425bcd39a8 ccac836e-ea05-4d49-a80f-d7d7d6e35bf7 |
Adverse event summaries are temporarily unavailable. Other product information remains available.