ADVIL COLD AND SINUS

Manufacturer
Haleon US Holdings LLC
Effective date
2025-06-13
Label type
HUMAN OTC DRUG LABEL
Version
16
Source
full-release
Hydrated at
2026-06-01 01:03:06

Label at a glance#

ProductADVIL COLD AND SINUS
Active ingredientIBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDE
Label structure11 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:

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
  • 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 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 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.

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 20-25°C (68-77°F). Avoid excessive heat above 40°C (104°F).
  • 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

Call toll free 1-800-88-ADVIL

Additional information – 40 + 40 ct.

SPL UNCLASSIFIED SECTION

Product inside sealed in plastic blister with foil backing. Do Not Use if plastic blister or foil barrier is broken.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Advil®

COLD & SINUS Non-Drowsy

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

Pseudoephedrine HCl 30 mg ‣ Nasal Decongestant

Relieves Sinus Pressure,
Nasal Congestion and Fever

40
COATED
CAPLETS*

*Oval-Shaped Tablets

Advil Cold & Sinus Tablet 0573-0180\advil-01
Advil Cold & Sinus Tablet 0573-0180\advil-01

Principal Display Panel – 40 + 40 ct.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Advil ®

COLD & SINUSNon-Drowsy

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

Pseudoephedrine HCl 30 mg ‣ Nasal Decongestant

Relieves Sinus Pressure,
Nasal Congestion and Fever

40 + 40
COATED
CAPLETS*

*Oval-Shaped Tablets

Advil Cold and Sinus 40 plus 40 Count
Advil Cold and Sinus 40 plus 40 Count

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1299021ibuprofen 200 MG / pseudoephedrine HCl 30 MG Oral TabletPSN16
1299021ibuprofen 200 MG / pseudoephedrine hydrochloride 30 MG Oral TabletSCD16

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0573-0180-102024-01-31C16284748780-11030e365-31c1-111a-e063-dadaa90a10e2Drug Facts
0573-0180-212024-01-31C16284748780-11030e365-31c1-111a-e063-dadaa90a10e2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0573-0180-10ADVIL COLD AND SINUS10 in 1 BLISTER PACKTABLET, COATED1016
0573-0180-10ADVIL COLD AND SINUS2 in 1 CARTONTABLET, COATED216
0573-0180-21ADVIL COLD AND SINUS10 in 1 BLISTER PACKTABLET, COATED1016
0573-0180-21ADVIL COLD AND SINUS4 in 1 CARTONTABLET, COATED416
0573-0180-80ADVIL COLD AND SINUS2 in 1 PACKAGETABLET, COATED216
0573-0180-80ADVIL COLD AND SINUS4 in 1 CARTONTABLET, COATED416
0573-2160-74ADVIL COLD AND SINUS4 in 1 CARTONTABLET, COATED416
0573-2160-74ADVIL COLD AND SINUS2 in 1 PACKAGETABLET, COATED216

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
0573-2160-74EA - Each0573-216085c8c543-ad93-481f-84b8-924cab1adff812025-10-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ibuprofenACTIVE INGREDIENTWK2XYI10QM7
pseudoephedrine hydrochlorideACTIVE INGREDIENT6V9V2RYJ8N7
ibuprofenACTIVE MOIETYWK2XYI10QM7
pseudoephedrineACTIVE MOIETY7CUC9DDI9F7
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZ7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61U7
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH487
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T7
POVIDONEINACTIVE INGREDIENTFZ989GH94E7
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OH7
SHELLACINACTIVE INGREDIENT46N107B71O7
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU47
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EU7
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141J7
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJ7
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP7
SUCROSEINACTIVE INGREDIENTC151H8M5547
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP7

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
0573-01800573-0180-10, 0573-0180-21, 0573-0180-80
0573-21600573-2160-74

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 36 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

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.

Inactive ingredient links page 1 of 2 · 84 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SHELLACSHELLAC46N107B71OTABLET, COATED / ORAL30 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ETABLET, COATED / ORAL49.2 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TABLET, COATED / ORAL516.42 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET, COATED / ORAL224 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JTABLET, COATED / ORAL123 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JTABLET, COATED / ORAL123 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, COATED / ORAL49 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, COATED / ORAL176 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
CARNAUBA WAXCARNAUBA WAXR12CBM0EIZTABLET, COATED / ORAL207.5 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, COATED / ORAL49 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, COATED / ORAL49 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, COATED / ORAL49 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHTABLET, COATED / ORAL0.8 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ETABLET, COATED / ORAL49.2 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, COATED / ORAL256 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, COATED / ORAL256 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET, COATED / ORAL224 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JTABLET, COATED / ORAL123 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TTABLET, COATED / ORAL0.8 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JTABLET, COATED / ORAL123 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET, COATED / ORAL224 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, COATED / ORAL256 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TTABLET, COATED / ORAL0.8 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TABLET, COATED / ORAL516.42 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
CARNAUBA WAXCARNAUBA WAXR12CBM0EIZTABLET, COATED / ORAL207.5 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, COATED / ORAL42.4 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, COATED / ORAL42.4 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, COATED / ORAL176 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, COATED / ORAL176 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHTABLET, COATED / ORAL0.8 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, COATED / ORAL920 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TTABLET, COATED / ORAL0.8 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, COATED / ORAL920 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, COATED / ORAL256 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, COATED / ORAL176 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TABLET, COATED / ORAL516.42 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ETABLET, COATED / ORAL49.2 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, COATED / ORAL42.4 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHTABLET, COATED / ORAL0.8 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ETABLET, COATED / ORAL49.2 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUTABLET, COATED / ORAL0.2 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TABLET, COATED / ORAL516.42 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
CARNAUBA WAXCARNAUBA WAXR12CBM0EIZTABLET, COATED / ORAL207.5 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, COATED / ORAL49 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JTABLET, COATED / ORAL123 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET, COATED / ORAL224 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, COATED / ORAL176 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, COATED / ORAL256 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHTABLET, COATED / ORAL0.8 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
SHELLACSHELLAC46N107B71OTABLET, COATED / ORAL30 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
SHELLACSHELLAC46N107B71OTABLET, COATED / ORAL30 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, COATED / ORAL920 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUTABLET, COATED / ORAL0.2 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, COATED / ORAL920 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TTABLET, COATED / ORAL0.8 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TTABLET, COATED / ORAL0.8 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, COATED / ORAL256 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHTABLET, COATED / ORAL0.8 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
SHELLACSHELLAC46N107B71OTABLET, COATED / ORAL30 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUTABLET, COATED / ORAL0.2 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ADVIL COLD AND SINUSIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDEHaleon US Holdings LLCfac22a47-f0de-4505-fd8a-768430cda0c12025-06-13WarningsExact identifier
ndc (package): 0573-2160-74
ndc (package): 0573-0180-10
ndc (package): 0573-0180-21
ndc (package): 0573-0180-80
ndc (product): 0573-0180
ndc (product): 0573-2160
ndc11 (package): 00573018080
ndc11 (package): 00573018010
ndc11 (package): 00573216074
ndc11 (package): 00573018021
spl id: cec76100-19bc-49c3-8805-7badb2a8bf28
spl set id: fac22a47-f0de-4505-fd8a-768430cda0c1

Reported adverse events (FAERS/openFDA)#

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