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 do not take longer than 10 days, unless directed by a doctor (see Warnings ) adults and children 12 years and over 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
store between 20º-25ºC (68º-77ºF) avoid excessive heat above 40°C (104°F) read all warnings and directions before use retain carton for complete product information
Drug Facts
Pain reliever/fever reducer
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.
This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:
Ask a doctor before use if
Ask a doctor or pharmacist before use if you are
When using this product
Stop use and ask a doctor if
If pregnant or breast-feeding, 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.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
| adults and children 12 years and over |
|
| children under 12 years |
|
colloidal silicon dioxide, corn starch, hypromellose, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone K30, pregelatinized starch, sodium starch glycolate, stearic acid, talc, titanium dioxide, triacetin
NDC 63868-794-01
QUALITY CHOICE
†Compare to Active Ingredient in MOTRIN® IB
Ibuprofen IB
Non-Prescription Strength
Ibuprofen Tablets USP, 200mg
Pain Reliever / Fever Reducer (NSAID)
100 Coated Tablets
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63868-794-01 | EA - Each | 63868-794 | 9da08d36-ec3d-448a-9aba-61f67bcfe797 | 1 | 2020-04-20 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| IBUPROFEN | ACTIVE INGREDIENT | WK2XYI10QM | 1 | |
| IBUPROFEN | ACTIVE MOIETY | WK2XYI10QM | 1 | |
| ALUMINUM OXIDE | INACTIVE INGREDIENT | LMI26O6933 | 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 | |
| POLYDEXTROSE | INACTIVE INGREDIENT | VH2XOU12IE | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | 1 | |
| POVIDONE K30 | INACTIVE INGREDIENT | U725QWY32X | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A CORN | INACTIVE INGREDIENT | AG9B65PV6B | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | 1 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | 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 |
|---|---|
| 63868-794 | 63868-794-01 |
Every source-derived ingredient row is available through these pages.
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 | TABLET, EXTENDED RELEASE / ORAL | 26 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL | NA | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, DELAYED RELEASE / ORAL | 2210 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | TABLET, DELAYED RELEASE / ORAL | 516 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, CHEWABLE / ORAL | 202 mg | ||
| TALC | TALC | 7SEV7J4R1U | GRANULE, DELAYED RELEASE / ORAL | 525 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | PASTE / DENTAL | 0.5 %w/w | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | IMPLANT / SUBCUTANEOUS | 1.04 mg | ||
| TRIACETIN | TRIACETIN | XHX3C3X673 | SUSPENSION, EXTENDED RELEASE / ORAL | 4 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | SYSTEM / INTRAVITREAL | 0.02 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, LIQUID FILLED / ORAL | 12 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | CAPSULE, LIQUID FILLED / ORAL | 101 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | GRANULE / ORAL | 202 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, FILM COATED / ORAL | 176 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, FOR SUSPENSION / ORAL | 131 mg | ||
| POLYDEXTROSE | POLYDEXTROSE | VH2XOU12IE | TABLET, FILM COATED / ORAL | 18 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, ORALLY DISINTEGRATING / ORAL | 68 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | RING / VAGINAL | 2 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 120 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER, FOR SUSPENSION / ORAL | 2553 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE / RESPIRATORY (INHALATION) | NA | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | SOAP / TOPICAL | 0.2 %w/w | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | SUSPENSION/ DROPS / OPHTHALMIC | 3 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | SUSPENSION, EXTENDED RELEASE / ORAL | 0.12 mg/5ml | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, DELAYED RELEASE PARTICLES / ORAL | 56 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | GRANULE / ORAL | 629 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | SUSPENSION / ORAL | 11 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | POWDER / RESPIRATORY (INHALATION) | 2 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | SYRUP / ORAL | 4 mg/5ml | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | SUSPENSION / ORAL | 900 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | PELLET / ORAL | 24 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | POWDER / ORAL | 378 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | CAPSULE, EXTENDED RELEASE / ORAL | 117 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | SYSTEM / TRANSDERMAL | 15 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 357 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 45 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | CAPSULE, EXTENDED RELEASE / ORAL | 64 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | CAPSULE, EXTENDED RELEASE / ORAL | 4.59 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, EXTENDED RELEASE / ORAL | 200 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | PELLET / SUBCUTANEOUS | 0.97 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | SUSPENSION, EXTENDED RELEASE / ORAL | 474 mg | ||
| TALC | TALC | 7SEV7J4R1U | POWDER / TOPICAL | 9235 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER / RESPIRATORY (INHALATION) | NA | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | CAPSULE / ORAL | 256.4 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | SUSPENSION / OPHTHALMIC | 14 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | MOUTHWASH / BUCCAL | 0.01 mg/1ml | ||
| TALC | TALC | 7SEV7J4R1U | CAPSULE, COATED / ORAL | 87 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET / SUBLINGUAL | 32.4 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET / ORAL | 750 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET / BUCCAL | 6 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, FILM COATED / ORAL | 91 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, COATED / ORAL | 320.75 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | CAPSULE, COATED, EXTENDED RELEASE / ORAL | 15 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET / ORAL | 1000 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | SUSPENSION / ORAL | 305 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | IMPLANT / SUBCUTANEOUS | 0.5 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | SUSPENSION / ORAL | 400 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE / ORAL | 300 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | FILM / BUCCAL | 3 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | LOTION / TOPICAL | 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 |
|---|---|---|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| d00f8eb3-acc1-a219-e053-2a95a90a5467 | dd1ead18-b89b-42c2-94d5-998835cbba03 | 2021-11-05 | Warnings | dd1ead18-b89b-42c2-94d5-998835cbba03 |
Adverse event summaries are temporarily unavailable. Other product information remains available.