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 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
Drug Facts
(in each tablet)
Ibuprofen USP, 200 mg (NSAID)**
**nonsteroidal anti-inflammatory drug
Pain reliever/fever reducer
Allergy alert: 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.
Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chances are higher if you:
Do not use
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 (1-800-222-1222) right away.
| Adults and children 12 years and older |
|
| Children under 12 years |
|
Call 1-877-835-5472
Monday through Friday 9AM - 5PM EST.
*Amneal Pharmaceuticals is not affiliated with the owner of the trademark Advil®
Distributed By:
Ameal Pharmaceuticals
Glasgow, KY 42141
Repackaged by:
Rebel Distributors Corp
Thousand Oaks, CA 91320
| 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 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 21695-065-06 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4920-48b1-e053-8cdaa90a720a | Ibuprofen Tablets, USP Fever reducer/ Pain Reliever (NSAID) |
| 21695-065-14 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4920-48b1-e053-8cdaa90a720a | Ibuprofen Tablets, USP Fever reducer/ Pain Reliever (NSAID) |
| 21695-065-28 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4920-48b1-e053-8cdaa90a720a | Ibuprofen Tablets, USP Fever reducer/ Pain Reliever (NSAID) |
| 21695-065-30 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4920-48b1-e053-8cdaa90a720a | Ibuprofen Tablets, USP Fever reducer/ Pain Reliever (NSAID) |
| 21695-065-50 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4920-48b1-e053-8cdaa90a720a | Ibuprofen Tablets, USP Fever reducer/ Pain Reliever (NSAID) |
| 21695-065-60 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4920-48b1-e053-8cdaa90a720a | Ibuprofen Tablets, USP Fever reducer/ Pain Reliever (NSAID) |
| 21695-065-90 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4920-48b1-e053-8cdaa90a720a | Ibuprofen Tablets, USP Fever reducer/ Pain Reliever (NSAID) |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 21695-065-06 | Ibuprofen (NSAID)Pain Releiver/ Fever Reducer | 6 in 1 BOTTLE | TABLET | 6 | 1 | |
| 21695-065-14 | Ibuprofen (NSAID)Pain Releiver/ Fever Reducer | 14 in 1 BOTTLE | TABLET | 14 | 1 | |
| 21695-065-28 | Ibuprofen (NSAID)Pain Releiver/ Fever Reducer | 28 in 1 BOTTLE | TABLET | 28 | 1 | |
| 21695-065-30 | Ibuprofen (NSAID)Pain Releiver/ Fever Reducer | 30 in 1 BOTTLE | TABLET | 30 | 1 | |
| 21695-065-50 | Ibuprofen (NSAID)Pain Releiver/ Fever Reducer | 50 in 1 BOTTLE | TABLET | 50 | 1 | |
| 21695-065-60 | Ibuprofen (NSAID)Pain Releiver/ Fever Reducer | 60 in 1 BOTTLE | TABLET | 60 | 1 | |
| 21695-065-90 | Ibuprofen (NSAID)Pain Releiver/ Fever Reducer | 90 in 1 BOTTLE | TABLET | 90 | 1 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 21695-065-14 | EA - Each | 21695-065 | ec67d892-4165-4604-83f6-1eaeb524c03d | 1 | 2012-07-24 |
| 21695-065-28 | EA - Each | 21695-065 | 132a04d6-ba56-4a5f-8c3e-659bf9460311 | 1 | 2012-07-24 |
| 21695-065-30 | EA - Each | 21695-065 | f03a3aba-b664-4918-ab1d-de9d584a2bc0 | 1 | 2012-07-24 |
| 21695-065-50 | EA - Each | 21695-065 | a5c3bc78-46f9-4fd0-a3ba-8c8e6f09a4ac | 1 | 2012-07-24 |
| 21695-065-60 | EA - Each | 21695-065 | 45ddc4d8-2a68-4c6a-9ad2-0de1f006cc67 | 1 | 2012-07-24 |
| 21695-065-90 | EA - Each | 21695-065 | 881ed50b-4a37-4d56-8893-94ea6e9c1763 | 1 | 2012-07-24 |
| 53746-140-01 | EA - Each | 53746-140 | 9b59909e-f012-4650-b0bb-48b247569696 | 1 | 2013-02-11 |
| 53746-140-10 | EA - Each | 53746-140 | ec68f427-dec6-4174-929c-cfc07f475edc | 1 | 2012-07-24 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| IBUPROFEN | ACTIVE INGREDIENT | WK2XYI10QM | 1 | |
| IBUPROFEN | ACTIVE MOIETY | WK2XYI10QM | 1 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | 1 | |
| CARNAUBA WAX | INACTIVE INGREDIENT | R12CBM0EIZ | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | 1 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | 1 | |
| POLYDEXTROSE | INACTIVE INGREDIENT | VH2XOU12IE | 1 | |
| POLYETHYLENE GLYCOL | INACTIVE INGREDIENT | 3WJQ0SDW1A | 1 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 1 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 21695-065 | 21695-065-06, 21695-065-14, 21695-065-28, 21695-065-30, 21695-065-50, 21695-065-60, 21695-065-90 |
| 53746-140 |
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 |
|---|---|---|---|---|---|---|
| POLYDEXTROSE | POLYDEXTROSE | VH2XOU12IE | TABLET / ORAL | 20 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET / ORAL | 980 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | TABLET / ORAL | 233 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET / ORAL | 1116 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET / ORAL | 232 mg | ||
| ANHYDROUS LACTOSE | ANHYDROUS LACTOSE | 3SY5LH9PMK | TABLET / ORAL | 6795 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | TABLET / ORAL | 216 mg | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | TABLET / ORAL | 167.8 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET / ORAL | 8 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET / ORAL | 750 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET / ORAL | 6184 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET / ORAL | 1127 mg |
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 |
|---|---|---|---|---|---|---|---|
| A071333-001 | IBUPROFEN | IBUPROFEN | 200MG | TABLET / ORAL | 1987-02-17 |
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 | A071333-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-02-17 | c2088c7a36db… | ||
| 2026-09-14 22:38:34 | 2026-08 | A071333-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-02-17 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A071333-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-02-17 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A071333-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-02-17 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A071333-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-02-17 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A071333-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-02-17 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A071333-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-02-17 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A071333-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-02-17 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A071333-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-02-17 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A071333-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-02-17 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A071333-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-02-17 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A071333-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-02-17 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A071333-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-02-17 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A071333-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-02-17 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A071333-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-02-17 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A071333-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-02-17 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A071333-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-02-17 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A071333-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-02-17 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A071333-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-02-17 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A071333-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-02-17 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A071333-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-02-17 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A071333-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-02-17 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A071333-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-02-17 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A071333-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-02-17 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A071333-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-02-17 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A071333-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-02-17 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A071333-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-02-17 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A071333-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-02-17 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A071333-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-02-17 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A071333-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-02-17 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A071333-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-02-17 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A071333-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-02-17 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A071333-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-02-17 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A071333-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-02-17 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A071333-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-02-17 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A071333-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-02-17 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A071333-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-02-17 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A071333-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-02-17 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A071333-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-02-17 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A071333-001 | IBUPROFEN | 200MG | TABLET / ORAL | 1987-02-17 | 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 |
|---|---|---|---|---|---|---|
| Ibuprofen Pain Releiver/ Fever Reducer | IBUPROFEN | Amneal Pharmaceuticals of New York LLC | ee241be0-35f8-4789-a71f-98de31d6a590 | 2023-12-31 | Warnings | 53746-140 |
| 7b4858fc-fea6-4e4c-886e-a2febe1ed2c3 | 7b4858fc-fea6-4e4c-886e-a2febe1ed2c3 | 2011-02-09 | Warnings | 7b4858fc-fea6-4e4c-886e-a2febe1ed2c3 7b4858fc-fea6-4e4c-886e-a2febe1ed2c3 |
Adverse event summaries are temporarily unavailable. Other product information remains available.