Indications and uses
temporarily relieves minor aches and pains due to: headache toothache backache menstrual cramps the common cold muscular aches minor pain of arthritis temporarily reduces fever
Advil
- Manufacturer
- JC World Bell Wholesale Co., Inc.
- Effective date
- 2025-06-27
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 6
- Source
- full-release
- Hydrated at
- 2026-06-01 01:05:53
Label at a glance#
ProductAdvil
Active ingredientIBUPROFEN
Label structure10 sections
Dosage and administration
• do not take more than directed • the smallest effective dose should be used • adults and children 12 years and over: 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
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient (in each tablet)
Ibuprofen 200 mg (NSAID)*
*nonsteroidal anti-inflammatory drug
Purpose
Pain reliever/Fever reducer
Uses
- temporarily relieves minor aches and pains due to:
- headache
- toothache
- backache
- menstrual cramps
- the common cold
- muscular aches
- minor pain of arthritis
- temporarily reduces fever
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 • 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
Heart attack and 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.
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 problems or serious side effects from taking pain relievers or fever reducers • 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
Ask a doctor or pharmacist before use if you are
• under a doctor’s care for any serious condition • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspiritin • taking any other drug
When using this product
• take with food or milk if stomach upset occurs
Stop use and aIf pregnant or breast-feeding,sk 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 • 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
If pregnant or breast-feeding,
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.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
• do not take more than directed • the smallest effective dose should be used • adults and children 12 years and over: 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
Other information
• read all warnings and directions before use. Keep carton. • store at 20-25°C (68-77°F) • avoid excessive heat above 40°C (104°F)
Inactive ingredients
acetylated monoglycerides, colloidal silicon dioxide, corn starch, croscarmellose sodium, methylparaben, microcrystalline cellulose, pharmaceutical glaze, pharmaceutical ink, povidone, pregelatinized starch, propylparaben, sodium benzoate, sodium lauryl sulfate, stearic acid, sucrose, synthetic iron oxide, titanium dioxide, white wax
Questions or comments?
call toll free 1-800-88-ADVIL
Package Labeling:50269-157-01
Package Labeling:50269-157-02
Package Labeling:50269-157-03
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 153008 | Advil 200 MG Oral Tablet | PSN | 6 |
| 310965 | ibuprofen 200 MG Oral Tablet | PSN | 6 |
| 153008 | ibuprofen 200 MG Oral Tablet [Advil] | SBD | 6 |
| 310965 | ibuprofen 200 MG Oral Tablet | SCD | 6 |
| 153008 | Advil 200 MG Oral Tablet | SY | 6 |
| 310965 | ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral Tablet | SY | 6 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| IBUPROFEN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20191108 |
DailyMed Product Concepts#
| 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 |
| c6f86816-7da6-43ea-8c25-ac9758311cc5 | Product name | 1 | 20220118 |
| 252e11b6-1a9a-4283-a242-df2c129c496d | Product name | 3 | 20170717 |
| 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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50269-157-01 | 2024-01-30 | C162847 | 48780-1 | 1030e365-5cd7-111a-e063-dadaa90a10e2 | Advil |
| 50269-157-02 | 2024-01-30 | C162847 | 48780-1 | 1030e365-5cd7-111a-e063-dadaa90a10e2 | Advil |
| 50269-157-03 | 2024-01-30 | C162847 | 48780-1 | 1030e365-5cd7-111a-e063-dadaa90a10e2 | Advil |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50269-157-01 | Advil | 1 in 1 BLISTER PACK | TABLET, COATED | 1 | 6 | |
| 50269-157-01 | Advil | 6 in 1 BOX | TABLET, COATED | 6 | 6 | |
| 50269-157-02 | Advil | 6 in 1 BOX | TABLET, COATED | 6 | 6 | |
| 50269-157-02 | Advil | 2 in 1 BLISTER PACK | TABLET, COATED | 2 | 6 | |
| 50269-157-03 | Advil | 2 in 1 POUCH | TABLET, COATED | 2 | 6 | |
| 50269-157-03 | Advil | 25 in 1 BOX | TABLET, COATED | 25 | 6 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0573-0154-17 | EA - Each | 0573-0154 | 3d25bf04-77a4-4ab6-a6d5-29c97f16e841 | 1 | 2014-01-04 |
| 0573-0154-21 | EA - Each | 0573-0154 | 825628f1-676d-4ead-b52d-bdacd97aecf6 | 1 | 2019-06-19 |
| 0573-0154-35 | EA - Each | 0573-0154 | 1cc383ab-9f32-4fc9-a8af-805a1cd19d47 | 1 | 2014-01-04 |
| 0573-0154-60 | EA - Each | 0573-0154 | f6468da4-ae22-4eb8-9c5e-38fd554773ba | 1 | 2025-01-14 |
| 0573-0154-75 | EA - Each | 0573-0154 | 2148d1df-7981-4f6d-b7a7-b0039ede5d51 | 1 | 2012-07-24 |
| 0573-0154-89 | EA - Each | 0573-0154 | b0c86057-e2b5-4985-a050-8fa2935ba7a5 | 1 | 2014-01-04 |
| 0573-0154-98 | EA - Each | 0573-0154 | a02ca783-2b81-4318-b6e0-fd8006119f94 | 1 | 2014-07-02 |
Products#
Every source-derived product name is available through these pages.
- Advil
- IBUPROFEN
- SILICON DIOXIDE
- DIACETYLATED MONOGLYCERIDES
- STARCH, CORN
- CROSCARMELLOSE SODIUM
- METHYLPARABEN
- MICROCRYSTALLINE CELLULOSE
- SHELLAC
- POVIDONE
- PROPYLPARABEN
- SODIUM BENZOATE
- SODIUM LAURYL SULFATE
- STEARIC ACID
- SUCROSE
- TITANIUM DIOXIDE
- WHITE WAX
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 50269-157 | 50269-157-01, 50269-157-02, 50269-157-03 |
| 0573-0154 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| DIACETYLATED MONOGLYCERIDES | 5Z17386USF | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| CROSCARMELLOSE SODIUM | M28OL1HH48 | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| SHELLAC | 46N107B71O | IACT |
| POVIDONE | FZ989GH94E | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| SODIUM LAURYL SULFATE | 368GB5141J | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| SUCROSE | C151H8M554 | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| WHITE WAX | 7G1J5DA97F | IACT |
| IBUPROFEN | WK2XYI10QM | ACTIB |
Source Document#
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N018989-001 | ADVIL | IBUPROFEN | 200MG | TABLET / ORAL | RLD, RS | 1984-05-18 |
Observed Orange Book product history#
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 | N018989-001 | ADVIL | 200MG | TABLET / ORAL | RLD, RS | 1984-05-18 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N018989-001 | ADVIL | 200MG | TABLET / ORAL | RLD, RS | 1984-05-18 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N018989-001 | ADVIL | 200MG | TABLET / ORAL | RLD, RS | 1984-05-18 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018989-001 | ADVIL | 200MG | TABLET / ORAL | RLD, RS | 1984-05-18 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N018989-001 | ADVIL | 200MG | TABLET / ORAL | RLD, RS | 1984-05-18 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018989-001 | ADVIL | 200MG | TABLET / ORAL | RLD, RS | 1984-05-18 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018989-001 | ADVIL | 200MG | TABLET / ORAL | RLD, RS | 1984-05-18 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018989-001 | ADVIL | 200MG | TABLET / ORAL | RLD, RS | 1984-05-18 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018989-001 | ADVIL | 200MG | TABLET / ORAL | RLD, RS | 1984-05-18 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018989-001 | ADVIL | 200MG | TABLET / ORAL | RLD, RS | 1984-05-18 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N018989-001 | ADVIL | 200MG | TABLET / ORAL | RLD, RS | 1984-05-18 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N018989-001 | ADVIL | 200MG | TABLET / ORAL | RLD, RS | 1984-05-18 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N018989-001 | ADVIL | 200MG | TABLET / ORAL | RLD, RS | 1984-05-18 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N018989-001 | ADVIL | 200MG | TABLET / ORAL | RLD, RS | 1984-05-18 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N018989-001 | ADVIL | 200MG | TABLET / ORAL | RLD, RS | 1984-05-18 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N018989-001 | ADVIL | 200MG | TABLET / ORAL | RLD, RS | 1984-05-18 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N018989-001 | ADVIL | 200MG | TABLET / ORAL | RLD, RS | 1984-05-18 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N018989-001 | ADVIL | 200MG | TABLET / ORAL | RLD, RS | 1984-05-18 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N018989-001 | ADVIL | 200MG | TABLET / ORAL | RLD, RS | 1984-05-18 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N018989-001 | ADVIL | 200MG | TABLET / ORAL | 1984-05-18 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N018989-001 | ADVIL | 200MG | TABLET / ORAL | RLD, RS | 1984-05-18 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N018989-001 | ADVIL | 200MG | TABLET / ORAL | RLD, RS | 1984-05-18 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N018989-001 | ADVIL | 200MG | TABLET / ORAL | RLD, RS | 1984-05-18 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N018989-001 | ADVIL | 200MG | TABLET / ORAL | RLD, RS | 1984-05-18 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N018989-001 | ADVIL | 200MG | TABLET / ORAL | RLD, RS | 1984-05-18 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N018989-001 | ADVIL | 200MG | TABLET / ORAL | RLD, RS | 1984-05-18 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N018989-001 | ADVIL | 200MG | TABLET / ORAL | 1984-05-18 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N018989-001 | ADVIL | 200MG | TABLET / ORAL | 1984-05-18 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N018989-001 | ADVIL | 200MG | TABLET / ORAL | 1984-05-18 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N018989-001 | ADVIL | 200MG | TABLET / ORAL | RLD, RS | 1984-05-18 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N018989-001 | ADVIL | 200MG | TABLET / ORAL | RLD, RS | 1984-05-18 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N018989-001 | ADVIL | 200MG | TABLET / ORAL | RLD, RS | 1984-05-18 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N018989-001 | ADVIL | 200MG | TABLET / ORAL | RLD, RS | 1984-05-18 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N018989-001 | ADVIL | 200MG | TABLET / ORAL | RLD, RS | 1984-05-18 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N018989-001 | ADVIL | 200MG | TABLET / ORAL | RLD, RS | 1984-05-18 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N018989-001 | ADVIL | 200MG | TABLET / ORAL | RLD, RS | 1984-05-18 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N018989-001 | ADVIL | 200MG | TABLET / ORAL | RLD, RS | 1984-05-18 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N018989-001 | ADVIL | 200MG | TABLET / ORAL | RLD, RS | 1984-05-18 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N018989-001 | ADVIL | 200MG | TABLET / ORAL | RLD, RS | 1984-05-18 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | N018989-001 | ADVIL | 200MG | TABLET / ORAL | RLD, RS | 1984-05-18 | f41ea6bd6efb… |
openFDA label cross-check#
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 |
|---|---|---|---|---|---|---|
| ADVIL | IBUPROFEN | Haleon US Holdings LLC | 1a665e64-9f30-be37-4a83-38789f1f1e89 | 2026-03-12 | Warnings | 0573-0154 |
| 388efabc-1749-3a11-e063-6394a90a8a32 | 0b83c9ed-3630-4c5c-9020-cf38183a6500 | 2025-06-27 | Warnings | 388efabc-1749-3a11-e063-6394a90a8a32 0b83c9ed-3630-4c5c-9020-cf38183a6500 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.