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
Ibuprofen 200 mg (NSAID)*
*nonsteroidal anti-inflammatory drug
Pain reliever/fever reducer
• 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
Allergy Alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
• hives • facial swelling • asthma (wheezing)
• shock • skin reddening • rash • blisters
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:
• are age 60 or older
• have had stomach ulcers or bleeding problems
• take a blood thinning (anticoagulant) or steroid drug
• take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
• have 3 or more alcoholic drinks every day while using this product
• take more or for a longer time than directed
• if you have ever had an allergic reaction to any other pain reliever/fever reducer
• right before or after heart surgery
• you have problems or serious side effects from taking pain relievers or fever reducers
• the stomach bleeding warning applies to you
• you have a history of stomach problems, such as heartburn
• you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
• you have asthma
• you are taking a diuretic
• taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
• under a doctor’s care for any serious condition
• taking any other drug
• take with food or milk if stomach upset occurs
• the risk of heart attack or stroke may increase if you use more than directed or for longer than directed
• you experience any of the following signs of stomach bleeding
• feel faint • vomit blood • have bloody or black stools
• have stomach pain that does not get better
• pain gets worse or lasts more than 10 days
• fever gets worse or lasts more than 3 days
• redness or swelling is present in the painful area
• any new symptoms appear
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).
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 |
• store between 20-25ºC (68-77ºF)
• see bottom of carton for lot number and expiration date
• do not use if pouch is opened
carnauba wax, colloidal silicon dioxide, corn starch, FD&C yellow no. 6, hypromellose, iron oxide, magnesium stearate, polydextrose, polyethylene glycol, pregelatinized starch, propylene glycol, shellac, stearic acid, titanium dioxide
Call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 67751-165-01 | 2023-03-16 | C162847 | 48780-1 | f386c64a-160b-0266-e053-dadaa90a7c1a | Motrin IB |
| 67751-165-02 | 2023-03-16 | C162847 | 48780-1 | f386c64a-160b-0266-e053-dadaa90a7c1a | Motrin IB |
| 67751-165-01 | 2023-01-30 | C162847 | 48780-1 | f386c64a-160b-0266-e053-dadaa90a7c1a | Motrin IB |
| 67751-165-02 | 2023-01-30 | C162847 | 48780-1 | f386c64a-160b-0266-e053-dadaa90a7c1a | Motrin IB |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50580-110-01 | EA - Each | 50580-110 | 867365d4-4425-426f-bf59-46f6dfabd14b | 1 | 2012-07-24 |
| 50580-110-02 | EA - Each | 50580-110 | 31401772-7c9b-4d71-a279-1ec4a77f0952 | 1 | 2012-07-24 |
| 50580-110-03 | EA - Each | 50580-110 | 914bf222-d4b9-4d69-bcff-2e30fd34d5f6 | 1 | 2012-07-24 |
| 50580-110-09 | EA - Each | 50580-110 | 1589ab72-c436-43bf-bf25-c883ae326ea2 | 1 | 2012-07-24 |
| 50580-110-19 | EA - Each | 50580-110 | 70e17cab-9b09-4dd3-833f-5acdbedda78b | 1 | 2012-07-24 |
| 50580-110-37 | EA - Each | 50580-110 | 87af4730-f4f3-48ea-a65f-b5c15c0e194c | 1 | 2012-07-24 |
| 50580-110-52 | EA - Each | 50580-110 | 82dfca75-6914-4194-8717-ea1fd3354c1b | 1 | 2012-07-24 |
| 50580-110-60 | EA - Each | 50580-110 | 6ea6daa9-b107-4f42-b767-9b0336899dfd | 1 | 2012-07-24 |
| 50580-110-62 | EA - Each | 50580-110 | 2b192ee9-708a-4776-96db-60c8310b4b84 | 1 | 2012-07-24 |
| 50580-110-64 | EA - Each | 50580-110 | 62c27713-706d-4be9-b73c-34d7ffc20955 | 1 | 2012-07-24 |
| 50580-110-95 | EA - Each | 50580-110 | d939130b-4e12-4684-a078-d07ccdbfba52 | 1 | 2012-07-24 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 67751-165 | 67751-165-01, 67751-165-02 |
| 50580-110 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CARNAUBA WAX | R12CBM0EIZ | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| FD&C YELLOW NO. 6 | H77VEI93A8 | IACT |
| HYPROMELLOSE, UNSPECIFIED | 3NXW29V3WO | IACT |
| FERRIC OXIDE RED | 1K09F3G675 | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| POLYDEXTROSE | VH2XOU12IE | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| SHELLAC | 46N107B71O | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| IBUPROFEN | WK2XYI10QM | ACTIB |
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 |
|---|---|---|---|---|---|---|---|
| N019012-001 | NUPRIN | IBUPROFEN | 200MG | TABLET / ORAL | 1984-05-18 | ||
| N019012-002 | NUPRIN | IBUPROFEN | 200MG | TABLET / ORAL | 1987-07-29 | ||
| N019012-003 | MOTRIN IB | IBUPROFEN | 200MG | TABLET / ORAL | RLD | 1990-12-17 | |
| N019012-004 | MOTRIN MIGRAINE PAIN | IBUPROFEN | 200MG | TABLET / ORAL | 2000-02-25 |
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 | N019012-001 | NUPRIN | 200MG | TABLET / ORAL | 1984-05-18 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N019012-002 | NUPRIN | 200MG | TABLET / ORAL | 1987-07-29 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N019012-003 | MOTRIN IB | 200MG | TABLET / ORAL | RLD | 1990-12-17 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N019012-004 | MOTRIN MIGRAINE PAIN | 200MG | TABLET / ORAL | 2000-02-25 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N019012-001 | NUPRIN | 200MG | TABLET / ORAL | 1984-05-18 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N019012-002 | NUPRIN | 200MG | TABLET / ORAL | 1987-07-29 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N019012-003 | MOTRIN IB | 200MG | TABLET / ORAL | RLD | 1990-12-17 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N019012-004 | MOTRIN MIGRAINE PAIN | 200MG | TABLET / ORAL | 2000-02-25 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N019012-001 | NUPRIN | 200MG | TABLET / ORAL | 1984-05-18 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N019012-002 | NUPRIN | 200MG | TABLET / ORAL | 1987-07-29 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N019012-003 | MOTRIN IB | 200MG | TABLET / ORAL | RLD | 1990-12-17 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N019012-004 | MOTRIN MIGRAINE PAIN | 200MG | TABLET / ORAL | 2000-02-25 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019012-001 | NUPRIN | 200MG | TABLET / ORAL | 1984-05-18 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019012-002 | NUPRIN | 200MG | TABLET / ORAL | 1987-07-29 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019012-003 | MOTRIN IB | 200MG | TABLET / ORAL | RLD | 1990-12-17 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019012-004 | MOTRIN MIGRAINE PAIN | 200MG | TABLET / ORAL | 2000-02-25 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N019012-001 | NUPRIN | 200MG | TABLET / ORAL | 1984-05-18 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N019012-002 | NUPRIN | 200MG | TABLET / ORAL | 1987-07-29 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N019012-003 | MOTRIN IB | 200MG | TABLET / ORAL | RLD | 1990-12-17 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N019012-004 | MOTRIN MIGRAINE PAIN | 200MG | TABLET / ORAL | 2000-02-25 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019012-001 | NUPRIN | 200MG | TABLET / ORAL | 1984-05-18 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019012-002 | NUPRIN | 200MG | TABLET / ORAL | 1987-07-29 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019012-003 | MOTRIN IB | 200MG | TABLET / ORAL | RLD | 1990-12-17 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019012-004 | MOTRIN MIGRAINE PAIN | 200MG | TABLET / ORAL | 2000-02-25 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019012-001 | NUPRIN | 200MG | TABLET / ORAL | 1984-05-18 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019012-002 | NUPRIN | 200MG | TABLET / ORAL | 1987-07-29 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019012-003 | MOTRIN IB | 200MG | TABLET / ORAL | RLD | 1990-12-17 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019012-004 | MOTRIN MIGRAINE PAIN | 200MG | TABLET / ORAL | 2000-02-25 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019012-001 | NUPRIN | 200MG | TABLET / ORAL | 1984-05-18 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019012-002 | NUPRIN | 200MG | TABLET / ORAL | 1987-07-29 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019012-003 | MOTRIN IB | 200MG | TABLET / ORAL | RLD | 1990-12-17 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019012-004 | MOTRIN MIGRAINE PAIN | 200MG | TABLET / ORAL | 2000-02-25 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019012-001 | NUPRIN | 200MG | TABLET / ORAL | 1984-05-18 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019012-002 | NUPRIN | 200MG | TABLET / ORAL | 1987-07-29 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019012-003 | MOTRIN IB | 200MG | TABLET / ORAL | RLD | 1990-12-17 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019012-004 | MOTRIN MIGRAINE PAIN | 200MG | TABLET / ORAL | 2000-02-25 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019012-001 | NUPRIN | 200MG | TABLET / ORAL | 1984-05-18 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019012-002 | NUPRIN | 200MG | TABLET / ORAL | 1987-07-29 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019012-003 | MOTRIN IB | 200MG | TABLET / ORAL | RLD | 1990-12-17 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019012-004 | MOTRIN MIGRAINE PAIN | 200MG | TABLET / ORAL | 2000-02-25 | 5bbf6a4d5a75… |
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 |
|---|---|---|---|---|---|---|
| f70b4446-281d-47c9-e053-6294a90aaa5d | b0a87ef4-eef7-459d-9842-6d4e5a08227f | 2023-03-16 | Warnings | b0a87ef4-eef7-459d-9842-6d4e5a08227f |
Adverse event summaries are temporarily unavailable. Other product information remains available.