OTC - ACTIVE INGREDIENT SECTION
Active Ingredient/Tablet Ibuprofen 200 mg (NSAID*) *nonsteroidal anti-inflammatory drug
Active Ingredient/Tablet Ibuprofen 200 mg (NSAID*) *nonsteroidal anti-inflammatory drug
Purpose-Pain Reliever/Fever Reducer
Uses
■ temporarily relieves minor aches and pains due to:
■ headache ■ the common cold ■ muscular aches
■ backache ■ toothache ■ minor pain of arthritis
■ menstrual cramps
■ temporarily reduces fever
Directions
Warnings
Allergy alert: Ibuprofen may cause a severe allergic reaction,
especially in people allergic to aspirin. Symptoms may include:
■ hives ■ facial swelling ■ asthma (wheezing) ■ shock
■ rash ■ skin reddening ■ blisters
If an allergic reaction occurs, stop use and seek medical help
right away.
Stomach bleeding warning: This product contains a
nonsteroidal anti-inflammatory drug (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
Do not use
■ if you have ever had an allergic reaction to any other pain
reliever/fever reducer
■ right before or after heart surgery
Ask a doctor before use if
■ stomach bleeding warning applies to you
■ you have a history of stomach problems, such as heartburn
■ you have problems or serious side effects from taking pain
relievers or fever reducers
■ you have high blood pressure, heart disease, liver cirrhosis,
kidney disease, or asthma
■ you are taking a diuretic
Ask a doctor or pharmacist before use if you are
■ under a doctor's care for any serious condition
■ taking aspirin to prevent heart attack or stroke, because
ibuprofen may decrease this benefit of aspirin
■ taking any other drug
When using this product
■ 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
Stop use and ask a doctor if
■ 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
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.
Prompt medical attention is critical for adults as well as for
children even if you do not notice any signs or symptoms.
Inactive ingredients carnauba wax*, cellulose,
croscarmellose sodium*, DC yellow 10*, FDC blue 2*, FDC
red 40*, FDC yellow 6*, hydroxypropyl methylcellulose,
magnesium stearate, maltodextrin*, polyethylene glycol*,
polysorbate 80*, red iron oxide, silicon dioxide, sodium starch
glycolate*, starch*, talc*, titanium dioxide, triacetin*
*Contains one or more of these ingredients.
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 42961-050 | 42961-050-01, 42961-050-02, 42961-050-03, 42961-050-04 |
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|---|
| A079129-001 | IBUPROFEN | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 |
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 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A079129-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2011-03-28 | 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 |
|---|---|---|---|---|---|---|
| 9cfb09b4-c98b-4205-85a7-119d56abe66b | ea2f8b53-2c50-4309-bf0d-756d416bbc14 | 2022-12-30 | Warnings | ea2f8b53-2c50-4309-bf0d-756d416bbc14 |
Adverse event summaries are temporarily unavailable. Other product information remains available.