• temporarily relieves these symptoms associated with the common cold or flu: • headache • fever • sinus pressure • nasal congestion • minor body aches and pains • reduces swelling of the nasal passages • temporarily restores freer breathing through the nose
• do not take more than directed • adults and children 12 years of age and over: • take 1 tablet every 4 hours while symptoms persist • do not use more than 6 tablets in any 24-hour period unless directed by a doctor • children under 12 years of age: do not use because this product contains too much medication for children under this age
Ibuprofen 200 mg (NSAID)*
Phenylephrine HCl 10 mg
*nonsteroidal anti-inflammatory drug
Pain reliever/fever reducer
Nasal decongestant
• temporarily relieves these symptoms associated with the common cold or flu:
• headache • fever • sinus pressure • nasal congestion • minor body aches and pains • reduces swelling of the nasal passages • temporarily restores freer breathing through the nose
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 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
• in children under 12 years of age because this product contains too much medication for children under this age
• if you have ever had an allergic reaction to any other pain reliever/fever reducer
• right before or after heart surgery
• if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product
• 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, thyroid disease, diabetes or have trouble urinating due to an enlarged prostate gland
• you are taking a diuretic
• under a doctor's care for any serious condition
• taking any other product that contains phenylephrine or any other nasal decongestant
• taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
• taking any other drug
• 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
• 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 7 days
• fever gets worse or lasts more than 3 days
• nasal congestion lasts for more than 7 days
• symptoms continue or get worse
• redness or swelling is present in the painful area
• you get nervous, dizzy, or sleepless
• any new symptoms appear
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.
In case of overdose, get medical help or contact a Poison Control Center right away.
• do not take more than directed
• adults and children 12 years of age and over:
• take 1 tablet every 4 hours while symptoms persist
• do not use more than 6 tablets in any 24-hour period unless directed by a doctor
• children under 12 years of age: do not use because this product contains too much medication for children under this age
• store at 20-25°C (68-77°F)
• avoid excessive heat above 40°C (104°F).
• read all warnings and directions before use. Keep carton.
acesulfame potassium, artificial flavor, carnauba wax, colloidal silicon dioxide, corn starch, croscarmellose sodium, glycerin, hypromellose, lactic acid, lecithin, maltodextrin, medium-chain triglycerides, microcrystalline cellulose, pharmaceutical ink, polydextrose, polyvinyl alcohol, pregelatinized starch, propyl gallate, sodium lauryl sulfate, stearic acid, sucralose, synthetic iron oxide, talc, titanium dioxide, triacetin, xanthan gum
Call weekdays from 9 AM to 5 PM EST toll free at 1-800-88-ADVIL
| Class | Version | Type | Effective |
|---|---|---|---|
| IBUPROFEN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20191108 |
| PHENYLEPHRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 67751-150-01 | 2023-03-15 | C162847 | 48780-1 | f386c64a-0568-0266-e053-dadaa90a7c1a | Advil Sinus Congestion & Pain Relief |
| 67751-150-02 | 2023-03-15 | C162847 | 48780-1 | f386c64a-0568-0266-e053-dadaa90a7c1a | Advil Sinus Congestion & Pain Relief |
| 67751-150-01 | 2023-01-30 | C162847 | 48780-1 | f386c64a-0568-0266-e053-dadaa90a7c1a | Advil Sinus Congestion & Pain Relief |
| 67751-150-02 | 2023-01-30 | C162847 | 48780-1 | f386c64a-0568-0266-e053-dadaa90a7c1a | Advil Sinus Congestion & Pain Relief |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 67751-150-01 | Advil Sinus Congestion and Pain Relief | 1 in 1 CARTON | TABLET, COATED | 1 | 3 | |
| 67751-150-01 | Advil Sinus Congestion and Pain Relief | 1 in 1 POUCH | TABLET, COATED | 1 | 3 | |
| 67751-150-02 | Advil Sinus Congestion and Pain Relief | 2 in 1 POUCH | TABLET, COATED | 2 | 3 | |
| 67751-150-02 | Advil Sinus Congestion and Pain Relief | 1 in 1 CARTON | TABLET, COATED | 1 | 3 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 67751-150 | ADVIL SINUS CONGESTION AND PAIN RELIEF (IBUPROFEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [NAVAJO MANUFACTURING COMPANY INC.] | 3 | Current NDC, Legacy NDC, 4 package rows | 20230316_531abadc-37fd-4953-95bc-a211a2ba6914.zip |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0573-0199-01 | EA - Each | 0573-0199 | fe6b0032-049b-4318-b7e7-4644ce1a56bb | 1 | 2022-06-06 |
| 0573-0199-11 | EA - Each | 0573-0199 | d09ca4e4-e359-4c8b-8e56-2eb0999773dd | 1 | 2019-06-19 |
| 0573-0199-21 | EA - Each | 0573-0199 | 7c6ed005-4992-481e-9ed0-12a03d86a846 | 1 | 2023-10-16 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 67751-150 | 67751-150-01, 67751-150-02 |
| 0573-0199 |
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 |
|---|---|---|---|---|---|---|---|
| N022565-001 | ADVIL CONGESTION RELIEF | IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE | 200MG;10MG | TABLET / ORAL | RLD, RS | 2010-05-27 |
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 | N022565-001 | ADVIL CONGESTION RELIEF | 200MG;10MG | TABLET / ORAL | RLD, RS | 2010-05-27 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | N022565-001 | ADVIL CONGESTION RELIEF | 200MG;10MG | TABLET / ORAL | RLD, RS | 2010-05-27 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N022565-001 | ADVIL CONGESTION RELIEF | 200MG;10MG | TABLET / ORAL | RLD, RS | 2010-05-27 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022565-001 | ADVIL CONGESTION RELIEF | 200MG;10MG | TABLET / ORAL | RLD, RS | 2010-05-27 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022565-001 | ADVIL CONGESTION RELIEF | 200MG;10MG | TABLET / ORAL | RLD, RS | 2010-05-27 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022565-001 | ADVIL CONGESTION RELIEF | 200MG;10MG | TABLET / ORAL | RLD, RS | 2010-05-27 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022565-001 | ADVIL CONGESTION RELIEF | 200MG;10MG | TABLET / ORAL | RLD, RS | 2010-05-27 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022565-001 | ADVIL CONGESTION RELIEF | 200MG;10MG | TABLET / ORAL | RLD, RS | 2010-05-27 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022565-001 | ADVIL CONGESTION RELIEF | 200MG;10MG | TABLET / ORAL | RLD, RS | 2010-05-27 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022565-001 | ADVIL CONGESTION RELIEF | 200MG;10MG | TABLET / ORAL | RLD, RS | 2010-05-27 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022565-001 | ADVIL CONGESTION RELIEF | 200MG;10MG | TABLET / ORAL | RLD, RS | 2010-05-27 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022565-001 | ADVIL CONGESTION RELIEF | 200MG;10MG | TABLET / ORAL | RLD, RS | 2010-05-27 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N022565-001 | ADVIL CONGESTION RELIEF | 200MG;10MG | TABLET / ORAL | RLD, RS | 2010-05-27 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022565-001 | ADVIL CONGESTION RELIEF | 200MG;10MG | TABLET / ORAL | RLD, RS | 2010-05-27 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022565-001 | ADVIL CONGESTION RELIEF | 200MG;10MG | TABLET / ORAL | RLD, RS | 2010-05-27 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022565-001 | ADVIL CONGESTION RELIEF | 200MG;10MG | TABLET / ORAL | RLD, RS | 2010-05-27 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N022565-001 | ADVIL CONGESTION RELIEF | 200MG;10MG | TABLET / ORAL | RLD, RS | 2010-05-27 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022565-001 | ADVIL CONGESTION RELIEF | 200MG;10MG | TABLET / ORAL | RLD, RS | 2010-05-27 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N022565-001 | ADVIL CONGESTION RELIEF | 200MG;10MG | TABLET / ORAL | RLD, RS | 2010-05-27 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N022565-001 | ADVIL CONGESTION RELIEF | 200MG;10MG | TABLET / ORAL | RLD, RS | 2010-05-27 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N022565-001 | ADVIL CONGESTION RELIEF | 200MG;10MG | TABLET / ORAL | RLD, RS | 2010-05-27 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N022565-001 | ADVIL CONGESTION RELIEF | 200MG;10MG | TABLET / ORAL | RLD, RS | 2010-05-27 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N022565-001 | ADVIL CONGESTION RELIEF | 200MG;10MG | TABLET / ORAL | RLD, RS | 2010-05-27 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N022565-001 | ADVIL CONGESTION RELIEF | 200MG;10MG | TABLET / ORAL | RLD, RS | 2010-05-27 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N022565-001 | ADVIL CONGESTION RELIEF | 200MG;10MG | TABLET / ORAL | RLD, RS | 2010-05-27 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N022565-001 | ADVIL CONGESTION RELIEF | 200MG;10MG | TABLET / ORAL | RLD, RS | 2010-05-27 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N022565-001 | ADVIL CONGESTION RELIEF | 200MG;10MG | TABLET / ORAL | RLD, RS | 2010-05-27 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N022565-001 | ADVIL CONGESTION RELIEF | 200MG;10MG | TABLET / ORAL | RLD, RS | 2010-05-27 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N022565-001 | ADVIL CONGESTION RELIEF | 200MG;10MG | TABLET / ORAL | RLD, RS | 2010-05-27 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | N022565-001 | ADVIL CONGESTION RELIEF | 200MG;10MG | TABLET / ORAL | RLD, RS | 2010-05-27 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N022565-001 | ADVIL CONGESTION RELIEF | 200MG;10MG | TABLET / ORAL | RLD, RS | 2010-05-27 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N022565-001 | ADVIL CONGESTION RELIEF | 200MG;10MG | TABLET / ORAL | RLD, RS | 2010-05-27 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N022565-001 | ADVIL CONGESTION RELIEF | 200MG;10MG | TABLET / ORAL | RLD, RS | 2010-05-27 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N022565-001 | ADVIL CONGESTION RELIEF | 200MG;10MG | TABLET / ORAL | RLD, RS | 2010-05-27 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N022565-001 | ADVIL CONGESTION RELIEF | 200MG;10MG | TABLET / ORAL | RLD, RS | 2010-05-27 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N022565-001 | ADVIL CONGESTION RELIEF | 200MG;10MG | TABLET / ORAL | RLD, RS | 2010-05-27 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N022565-001 | ADVIL CONGESTION RELIEF | 200MG;10MG | TABLET / ORAL | RLD, RS | 2010-05-27 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N022565-001 | ADVIL CONGESTION RELIEF | 200MG;10MG | TABLET / ORAL | RLD, RS | 2010-05-27 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N022565-001 | ADVIL CONGESTION RELIEF | 200MG;10MG | TABLET / ORAL | RLD, RS | 2010-05-27 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N022565-001 | ADVIL CONGESTION RELIEF | 200MG;10MG | TABLET / ORAL | RLD, RS | 2010-05-27 | 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 |
|---|---|---|---|---|---|---|
| ADVIL SINUS CONGESTION AND PAIN | IBUPROFEN, PHENYLEPHRINE HYDROCHLORIDE | Haleon US Holdings LLC | b1e29c19-fe03-4d2b-b966-0adf4eb4b4cf | 2025-07-22 | Warnings | 0573-0199 |
| Advil Sinus Congestion and Pain Relief | IBUPROFEN, PHENYLEPHRINE HYDROCHLORIDE | Navajo Manufacturing Company Inc. | 531abadc-37fd-4953-95bc-a211a2ba6914 | 2023-03-15 | Warnings | 67751-150-02 67751-150-01 67751-150 67751015002 67751015001 f6f7501a-9ba4-82ea-e053-6294a90a298e 531abadc-37fd-4953-95bc-a211a2ba6914 |
Adverse event summaries are temporarily unavailable. Other product information remains available.