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
store between 20-25°C (68-77°F) do not use if foil inner seal is broken or missing
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
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.
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
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.
if you have ever had an allergic reaction to ibuprofen or 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, kidney disease, asthma or had a stroke
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
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
you have symptoms of heart problems or stroke:
• chest pain
• trouble breathing
• weakness in one part or side of body
• slurred speech
• leg swelling
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 at 20 weeks or later in 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 20-25°C (68-77°F)
do not use if foil inner seal is broken or missing
colloidal silicon dioxide, FD&C yellow #6, maize starch, polyethylene glycol, polyvinyl alcohol, povidone k30, pregelatinized starch, sodium starch glycolate, stearic acid, talc, titanium dioxide
call 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST
| Class | Version | Type | Effective |
|---|---|---|---|
| IBUPROFEN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20191108 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 1e73f975-1ce7-705e-2bcf-788b1b5e24ba | Product name | 5 | 20251124 |
| 16cde546-8deb-4df2-a072-dab5566ede95 | Product name | 1 | 20231003 |
| f6d1b8d7-3bd1-4248-eddd-b60565c88015 | Product name | 4 | 20230808 |
| 594e2c86-3079-4e6e-96c9-48f7a8afc78d | Product name | 1 | 20230718 |
| 874f4e63-49d2-5150-5d77-052172814ebd | Product name | 6 | 20230105 |
| 557673c2-8256-b351-e863-4ec71a5a64b0 | Product name | 2 | 20160714 |
| dbc9a339-6215-4e94-9546-57a3b34902ce | Product name | 1 | 20160517 |
| 61c18d4e-b552-5478-8fc0-df38b93e3100 | Product name | 1 | 20140508 |
| 7b2938c9-7eb7-e312-ae90-f54f4240361e | Product name | 1 | 20140508 |
| 997601aa-bb5f-6971-6b90-a21132c12c7b | Product name | 1 | 20140508 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 36800-662-20 | Ibuprofen | 200 in 1 BOTTLE | TABLET | 200 | 5 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 36800-662 | 36800-662-20 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| FD&C YELLOW NO. 6 | H77VEI93A8 | IACT |
| IBUPROFEN | WK2XYI10QM | ACTIB |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | 5856J3G2A2 | IACT |
| POVIDONE K30 | U725QWY32X | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| POLYVINYL ALCOHOL, UNSPECIFIED | 532B59J990 | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| TALC | 7SEV7J4R1U | IACT |
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 |
|---|---|---|---|---|---|---|---|
| A202312-001 | IBUPROFEN | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 |
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 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A202312-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2016-10-07 | 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 |
|---|---|---|---|---|---|---|
| Ibuprofen | IBUPROFEN | TOPCO ASSOCIATES LLC | 1a00c85b-2ba5-32c3-e063-6294a90af148 | 2025-12-19 | Warnings | 36800-662-20 36800-662 36800066220 4652df48-b67b-3921-e063-6394a90adb21 1a00c85b-2ba5-32c3-e063-6294a90af148 |
Adverse event summaries are temporarily unavailable. Other product information remains available.