Indications and uses
Temporarily relieves minor aches and pains due to Common cold headache minor pain of arthritis toothache backache muscular aches menstrual cramps temporarily reduces fever
Temporarily relieves minor aches and pains due to Common cold headache minor pain of arthritis toothache backache muscular aches 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 tablet every 4-6 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 of age Ask a doctor
Ibuprofen, 200mg (NSAID*)
*nonsteroidal anti-inflammatory drug
Pain Releiver / Fever Reducer
nonsteroidal anti-inflammatory drug
Temporarily relieves minor aches and pains due to
temporarily reduces fever
Allergy alert
Ibuprofen may cause severe allergic reactions, 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 a NSAID, which may cause severe stomach bleeding. The chances are higher if you:
Heart attack or stroke warning
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.
Contains FD+C Yellow No. 5 (tartrazine) as a color additive
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Adults and children 12 years and older
Children under 12 years of age
You experience any of the following signs of stomach bleeding:
You have symptoms of heart problems or stroke
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.
TAMPER EVIDENTchild resistant packets. Do not use any opened or torn packets.
Colloidal Silicon Dioxide, Croscarmellose Sodium, FD&C Blue #2, FD&C Yellow #5, FD&C Yellow #6, Iron Oxide Red, Lecithin, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinyl Alcohol, Pregelatinized Starch, Talc, Titanium Dioxide
Call 1-888-296-9067
IMPORTANT: READ ALL PRODUCT INFORMATION BEFORE USING. KEEP BOX FOR COMPLETE WARNINGS AND INFORMATION.
Take with food or milk if stomach upset occurs
Distributed By:
Trifecta Pharmaceuticals USA®
Ft. Lauderdale, FL. 33301 USA
1-888-296-9067
*This product is not manufactured or distributed by Pfizer, owner of the registered trademark Advil®
Reorder No. 2022
Made in the USA
| 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 |
| 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 |
|---|---|---|---|---|---|---|
| 69396-172-01 | Ibuprofen | 1000 in 1 BOTTLE | TABLET | 1000 | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 69396-172 | 69396-172-01 |
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 |
|---|---|---|---|---|---|---|---|
| A207095-001 | IBUPROFEN | IBUPROFEN | 200MG | TABLET / ORAL | 2017-05-05 | ||
| A207095-002 | IBUPROFEN | IBUPROFEN | 200MG | TABLET / ORAL | 2018-08-21 |
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 | A207095-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-05-05 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A207095-002 | IBUPROFEN | 200MG | TABLET / ORAL | 2018-08-21 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A207095-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-05-05 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A207095-002 | IBUPROFEN | 200MG | TABLET / ORAL | 2018-08-21 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A207095-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-05-05 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A207095-002 | IBUPROFEN | 200MG | TABLET / ORAL | 2018-08-21 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207095-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-05-05 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207095-002 | IBUPROFEN | 200MG | TABLET / ORAL | 2018-08-21 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A207095-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-05-05 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A207095-002 | IBUPROFEN | 200MG | TABLET / ORAL | 2018-08-21 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207095-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-05-05 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207095-002 | IBUPROFEN | 200MG | TABLET / ORAL | 2018-08-21 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207095-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-05-05 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207095-002 | IBUPROFEN | 200MG | TABLET / ORAL | 2018-08-21 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207095-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-05-05 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207095-002 | IBUPROFEN | 200MG | TABLET / ORAL | 2018-08-21 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207095-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-05-05 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207095-002 | IBUPROFEN | 200MG | TABLET / ORAL | 2018-08-21 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207095-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-05-05 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207095-002 | IBUPROFEN | 200MG | TABLET / ORAL | 2018-08-21 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207095-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-05-05 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207095-002 | IBUPROFEN | 200MG | TABLET / ORAL | 2018-08-21 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A207095-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-05-05 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A207095-002 | IBUPROFEN | 200MG | TABLET / ORAL | 2018-08-21 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207095-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-05-05 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207095-002 | IBUPROFEN | 200MG | TABLET / ORAL | 2018-08-21 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207095-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-05-05 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207095-002 | IBUPROFEN | 200MG | TABLET / ORAL | 2018-08-21 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207095-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-05-05 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207095-002 | IBUPROFEN | 200MG | TABLET / ORAL | 2018-08-21 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A207095-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-05-05 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A207095-002 | IBUPROFEN | 200MG | TABLET / ORAL | 2018-08-21 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A207095-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-05-05 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A207095-002 | IBUPROFEN | 200MG | TABLET / ORAL | 2018-08-21 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A207095-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-05-05 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A207095-002 | IBUPROFEN | 200MG | TABLET / ORAL | 2018-08-21 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A207095-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-05-05 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A207095-002 | IBUPROFEN | 200MG | TABLET / ORAL | 2018-08-21 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A207095-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-05-05 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A207095-001 | IBUPROFEN | 200MG | TABLET / ORAL | 2017-05-05 | bb7c543d1eb4… |
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 | Trifecta Pharmaceuticals USA LLC | 37299475-e2f3-de26-e063-6394a90ad62d | 2025-06-09 | Warnings | 69396-172-01 69396-172 69396017201 3729a3d5-0ccd-378f-e063-6294a90aa65c 37299475-e2f3-de26-e063-6394a90ad62d |
Adverse event summaries are temporarily unavailable. Other product information remains available.