Advil Sinus Congestion and Pain

Manufacturer
Select Corporation
Effective date
2022-04-12
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:49:11

Label at a glance#

ProductAdvil Sinus Congestion and Pain
Active ingredientIbuprofen, PHENYLEPHRINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

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

Dosage and administration

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

Storage and handling

store at 20-25°C (68-77°F). Avoid excessive heat above 40°C (104°F). read all warnings and directions before use. Keep card.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each tablet)Purposes
Ibuprofen 200 mg (NSAID)* Pain reliever/fever reducer
Phenylephrine HCl 10 mgNasal decongestant

* nonsteroidal anti-inflammatory drug

Uses

INDICATIONS & USAGE SECTION

  • 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

Warnings

WARNINGS SECTION

Allergy alert

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

OTC - DO NOT USE SECTION

  • 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

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

  • 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, have trouble urinating due to an enlarged prostate gland, or had a stroke
  • you are taking a diuretic

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • 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

When using this product

OTC - WHEN USING SECTION

  • take with food or milk if stomach upset occurs

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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 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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

Other information

STORAGE AND HANDLING SECTION

  • store at 20-25°C (68-77°F). Avoid excessive heat above 40°C (104°F).
  • read all warnings and directions before use. Keep card.

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

Call weekdays from 9 AM to 5 PM EST toll free at 1-800-88-ADVIL

SPL UNCLASSIFIED SECTION

Product Repackaged and Distributed
with permission of Pfizer Consumer Healthcare by:
Select Corporation Carrollton, TX 75007

PRINCIPAL DISPLAY PANEL - 1 Tablet Pouch Blister Pack

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NON-DROWSY

Advil®

SINUS
CONGESTION & PAIN

Ibuprofen 200 mg Pain Reliever/Fever Reducer (NSAID)
Phenlephrine HCl 10 mg Nasal Decongestant

ONE
TALBET
DOSE!

1 PACKET OF
1 COATED TABLET

PRINCIPAL DISPLAY PANEL - 1 Tablet Pouch Blister Pack
PRINCIPAL DISPLAY PANEL - 1 Tablet Pouch Blister Pack

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1369775ibuprofen 200 MG / phenylephrine HCl 10 MG Oral TabletPSN2
1369775ibuprofen 200 MG / phenylephrine hydrochloride 10 MG Oral TabletSCD2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
IBUPROFEN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20191108
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015Product name420230808
874f4e63-49d2-5150-5d77-052172814ebdProduct name620230105
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52904-782-03Advil Sinus Congestion and Pain1 in 1 BLISTER PACKTABLET, COATED12
52904-782-03Advil Sinus Congestion and Pain1 in 1 POUCHTABLET, COATED12
52904-782-04Advil Sinus Congestion and Pain2 in 1 BLISTER PACKTABLET, COATED22
52904-782-04Advil Sinus Congestion and Pain1 in 1 POUCHTABLET, COATED12
52904-782-25Advil Sinus Congestion and Pain25 in 1 CARTONTABLET, COATED252
52904-782-25Advil Sinus Congestion and Pain1 in 1 POUCHTABLET, COATED12
52904-782-50Advil Sinus Congestion and Pain1 in 1 POUCHTABLET, COATED12
52904-782-50Advil Sinus Congestion and Pain50 in 1 CARTONTABLET, COATED502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52904-782ADVIL SINUS CONGESTION AND PAIN (IBUPROFEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [SELECT CORPORATION]2Legacy NDC, 8 package rows20220414_dc7ebdf5-52f1-4341-a2cb-c96fa6272dd9.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0573-0199-01EA - Each0573-0199fe6b0032-049b-4318-b7e7-4644ce1a56bb12022-06-06
0573-0199-11EA - Each0573-0199d09ca4e4-e359-4c8b-8e56-2eb0999773dd12019-06-19
0573-0199-21EA - Each0573-01997c6ed005-4992-481e-9ed0-12a03d86a84612023-10-16

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52904-78252904-782-03, 52904-782-04, 52904-782-25, 52904-782-50
0573-0199

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N022565-001ADVIL CONGESTION RELIEFIBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE200MG;10MGTABLET / ORALRLD, RS2010-05-27

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.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-2784e616aacf4f…
2026-08-18 06:07:402026-07N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-278072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-275c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-275d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-274b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-2774a2ff9319b5…
2022-03-09 01:35 UTC2022-03N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-27bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-27782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-2787673890dc5c…
2021-03-12 10:30 UTC2021-03N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-275aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-278869cabd3fbd…
2020-11-12 02:37 UTC2020-11N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-27c0c555d07b60…
2019-12-14 00:12 UTC2019-12N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-273f01610625f2…
2019-09-15 20:21 UTC2019-09N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-27b00525d2431f…
2019-07-19 19:46 UTC2019-07N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-27ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-276a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-271c564ffb4f44…
2023-12-20 04:57 UTC2023-12N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-27ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-27a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-279b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-27a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-273f0d92c62455…
2023-05-13 08:27 UTC2023-05N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-27053a50430f4f…
2023-01-26 05:58 UTC2023-01N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-273bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-273a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N022565-001ADVIL CONGESTION RELIEF200MG;10MGTABLET / ORALRLD, RS2010-05-27f41ea6bd6efb…

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.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ADVIL SINUS CONGESTION AND PAINIBUPROFEN, PHENYLEPHRINE HYDROCHLORIDEHaleon US Holdings LLCb1e29c19-fe03-4d2b-b966-0adf4eb4b4cf2025-07-22WarningsExact identifier
ndc (product): 0573-0199
bf8fc6fa-d880-4cd1-a815-1d3ad3cd955edc7ebdf5-52f1-4341-a2cb-c96fa6272dd92022-04-12WarningsExact identifier
spl id: bf8fc6fa-d880-4cd1-a815-1d3ad3cd955e
spl set id: dc7ebdf5-52f1-4341-a2cb-c96fa6272dd9

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.