FDA.reportPublic FDA data

ADVIL COLD AND SINUS

Manufacturer
Haleon US Holdings LLC
Effective date
2026-02-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:36:23

Label at a glance#

ProductADVIL COLD AND SINUS
Active ingredientIBUPROFEN, PSEUDOEPHEDRINE 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

Dosage and administration

▪ do not take more than directed ▪ the smallest effective dose should be used ▪ adults and children 12 years of age and over: ▪ take 1 caplet every 4 to 6 hours while symptoms persist. If symptoms do not respond to 1 caplet, 2 caplets may be used. ▪ do not use more than 6 caplets in any 24-hour period unless directed by a doctor ▪ children under 12 years of age: do not use

Label contents#

Full prescribing information#

Active ingredients (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Ibuprofen 200 mg (NSAID)*

Pseudoephedrine HCl 30 mg

*nonsteroidal anti-inflammatory drug

Purposes

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Nasal decongestant

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

Warnings

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

  • in children under 12 years of age
  • if you have ever had an allergic reaction to any 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 you prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before us if

OTC - ASK DOCTOR SECTION

  • stomach bleeding warning applies to you
  • you have problems or serious side effects from taking pain relievers or fever reducer
  • 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 pseudoephedrine 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
  • 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

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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
  • the smallest effective dose should be used
  • adults and children 12 years of age and over:
    • take 1 caplet every 4 to 6 hours while symptoms persist. If symptoms do not respond to 1 caplet, 2 caplets may be used.
    • do not use more than 6 caplets in any 24-hour period unless directed by a doctor
  • children under 12 years of age: do not use

Other information

SPL UNCLASSIFIED SECTION

  • Store at room temperature not exceeding 30°C
  • read all warnings and directions before use. Keep carton.

Inactive ingredients

INACTIVE INGREDIENT SECTION

acetylated monoglycerides, carnauba wax, 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 oxides, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

Contact us at www.haleon.com Adverse event reporting to farmacovigilanciacar@haleon.com Complaints reporting to pqc.caricam@gsk.com

Additional Information

SPL UNCLASSIFIED SECTION

Do Not Use if sealed pouch is broken or torn.

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Advil®

Cold & Sinus

IBUPROFEN 200mg ‣ ‣ Pain Reliever / Fever Reducer (NSAID)

PSEUDOEPHEDRINE HCl 30mg ‣ ‣ Nasal Decongestant

Relieves Sinus Pressure, Nasal Congestion, and Fever

50 Pouches of 2 Coated Caplets*

*Oval-Shaped Tablets

Advil Cold and Sinus 2x50 LatAmAdvil Cold and Sinus 2x50 LatAm

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1299021ibuprofen 200 MG / pseudoephedrine HCl 30 MG Oral TabletPSN1
1299021ibuprofen 200 MG / pseudoephedrine hydrochloride 30 MG Oral TabletSCD1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
IBUPROFEN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20191108
PSEUDOEPHEDRINE 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
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
e974e22d-8688-7d92-1e87-40c1079e170cProduct name320151125
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66Product name120140508
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
70a83adc-6047-bbea-5a08-dfd304aa47d2Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
858ce051-9941-aafc-8c7c-44a8e0227463Product name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0573-0180-39ADVIL COLD AND SINUS2 in 1 POUCHTABLET, COATED21
0573-0180-39ADVIL COLD AND SINUS50 in 1 CARTONTABLET, COATED501

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0573-0180-10EA - Each0573-01804894699b-f98e-4132-a1d5-b7834976661812012-07-24
0573-0180-21EA - Each0573-0180d5744bb2-aee3-42fa-bfea-501ba674232b12012-07-24

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0573-01800573-0180-39

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
IBUPROFENWK2XYI10QMACTIB
PSEUDOEPHEDRINE HYDROCHLORIDE6V9V2RYJ8NACTIB
DIACETYLATED MONOGLYCERIDES5Z17386USFIACT
CARNAUBA WAXR12CBM0EIZIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
STARCH, CORNO8232NY3SJIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
METHYLPARABENA2I8C7HI9TIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
SHELLAC46N107B71OIACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
PROPYLPARABENZ8IX2SC1OHIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM LAURYL SULFATE368GB5141JIACT
STEARIC ACID4ELV7Z65APIACT
SUCROSEC151H8M554IACT
FERROUS OXIDEG7036X8B5HIACT
TITANIUM DIOXIDE15FIX9V2JPIACT

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
N019771-001ADVIL COLD AND SINUSIBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE200MG;30MGTABLET / ORALRLD, RS1989-09-19

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 22:38:342026-08N019771-001ADVIL COLD AND SINUS200MG;30MGTABLET / ORALRLD, RS1989-09-1984e616aacf4f…
2026-08-18 06:07:402026-07N019771-001ADVIL COLD AND SINUS200MG;30MGTABLET / ORALRLD, RS1989-09-19caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N019771-001ADVIL COLD AND SINUS200MG;30MGTABLET / ORALRLD, RS1989-09-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019771-001ADVIL COLD AND SINUS200MG;30MGTABLET / ORALRLD, RS1989-09-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08N019771-001ADVIL COLD AND SINUS200MG;30MGTABLET / ORALRLD, RS1989-09-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019771-001ADVIL COLD AND SINUS200MG;30MGTABLET / ORALRLD, RS1989-09-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019771-001ADVIL COLD AND SINUS200MG;30MGTABLET / ORALRLD, RS1989-09-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019771-001ADVIL COLD AND SINUS200MG;30MGTABLET / ORALRLD, RS1989-09-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019771-001ADVIL COLD AND SINUS200MG;30MGTABLET / ORALRLD, RS1989-09-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019771-001ADVIL COLD AND SINUS200MG;30MGTABLET / ORALRLD, RS1989-09-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019771-001ADVIL COLD AND SINUS200MG;30MGTABLET / ORALRLD, RS1989-09-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N019771-001ADVIL COLD AND SINUS200MG;30MGTABLET / ORALRLD, RS1989-09-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019771-001ADVIL COLD AND SINUS200MG;30MGTABLET / ORALRLD, RS1989-09-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019771-001ADVIL COLD AND SINUS200MG;30MGTABLET / ORALRLD, RS1989-09-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019771-001ADVIL COLD AND SINUS200MG;30MGTABLET / ORALRLD, RS1989-09-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05N019771-001ADVIL COLD AND SINUS200MG;30MGTABLET / ORALRLD, RS1989-09-198072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N019771-001ADVIL COLD AND SINUS200MG;30MGTABLET / ORALRLD, RS1989-09-195c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N019771-001ADVIL COLD AND SINUS200MG;30MGTABLET / ORALRLD, RS1989-09-195d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N019771-001ADVIL COLD AND SINUS200MG;30MGTABLET / ORALRLD, RS1989-09-194b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N019771-001ADVIL COLD AND SINUS200MG;30MGTABLET / ORALRLD, RS1989-09-1974a2ff9319b5…
2022-03-09 01:35 UTC2022-03N019771-001ADVIL COLD AND SINUS200MG;30MGTABLET / ORALRLD, RS1989-09-19bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N019771-001ADVIL COLD AND SINUS200MG;30MGTABLET / ORALRLD, RS1989-09-19782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N019771-001ADVIL COLD AND SINUS200MG;30MGTABLET / ORALRLD, RS1989-09-1987673890dc5c…
2021-03-12 10:30 UTC2021-03N019771-001ADVIL COLD AND SINUS200MG;30MGTABLET / ORALRLD, RS1989-09-195aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N019771-001ADVIL COLD AND SINUS200MG;30MGTABLET / ORALRLD, RS1989-09-198869cabd3fbd…
2020-11-12 02:37 UTC2020-11N019771-001ADVIL COLD AND SINUS200MG;30MGTABLET / ORALRLD, RS1989-09-19c0c555d07b60…
2019-12-14 00:12 UTC2019-12N019771-001ADVIL COLD AND SINUS200MG;30MGTABLET / ORALRLD, RS1989-09-193f01610625f2…
2019-09-15 20:21 UTC2019-09N019771-001ADVIL COLD AND SINUS200MG;30MGTABLET / ORALRLD, RS1989-09-19b00525d2431f…
2019-07-19 19:46 UTC2019-07N019771-001ADVIL COLD AND SINUS200MG;30MGTABLET / ORALRLD, RS1989-09-19ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N019771-001ADVIL COLD AND SINUS200MG;30MGTABLET / ORALRLD, RS1989-09-196a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N019771-001ADVIL COLD AND SINUS200MG;30MGTABLET / ORALRLD, RS1989-09-191c564ffb4f44…
2023-12-20 04:57 UTC2023-12N019771-001ADVIL COLD AND SINUS200MG;30MGTABLET / ORALRLD, RS1989-09-19ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N019771-001ADVIL COLD AND SINUS200MG;30MGTABLET / ORALRLD, RS1989-09-19a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N019771-001ADVIL COLD AND SINUS200MG;30MGTABLET / ORALRLD, RS1989-09-199b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N019771-001ADVIL COLD AND SINUS200MG;30MGTABLET / ORALRLD, RS1989-09-19a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N019771-001ADVIL COLD AND SINUS200MG;30MGTABLET / ORALRLD, RS1989-09-193f0d92c62455…
2023-05-13 08:27 UTC2023-05N019771-001ADVIL COLD AND SINUS200MG;30MGTABLET / ORALRLD, RS1989-09-19053a50430f4f…
2023-01-26 05:58 UTC2023-01N019771-001ADVIL COLD AND SINUS200MG;30MGTABLET / ORALRLD, RS1989-09-193bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N019771-001ADVIL COLD AND SINUS200MG;30MGTABLET / ORALRLD, RS1989-09-193a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N019771-001ADVIL COLD AND SINUS200MG;30MGTABLET / ORALRLD, RS1989-09-19f41ea6bd6efb…

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
f6894629-6c85-41b2-ae8f-a3a89a7401fdf6894629-6c85-41b2-ae8f-a3a89a7401fd2026-02-02WarningsExact identifier
spl id: f6894629-6c85-41b2-ae8f-a3a89a7401fd
spl set id: f6894629-6c85-41b2-ae8f-a3a89a7401fd
ADVIL COLD AND SINUSIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDEHaleon US Holdings LLCfac22a47-f0de-4505-fd8a-768430cda0c12025-06-13WarningsExact identifier
ndc (product): 0573-0180

Reported adverse events (FAERS/openFDA)#

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