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ADVIL COLD AND SINUS

ibuprofen and pseudoephedrine hydrochloride · Tablet, Coated

Over-the-counter NDA RLD Official labelling
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
ADVIL COLD AND SINUS
Generic name
ibuprofen and pseudoephedrine hydrochloride
Dosage form
Tablet, Coated
Route
Oral
Marketing category
NDA · NDA
Labeler
Haleon US Holdings LLC
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
2
Packages
4
Data completeness
76% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Ibuprofen 200 mg/1 310965 View
Pseudoephedrine Hydrochloride 30 mg/1 1305603 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet, Coated
Route of administration
Oral
Presentations
6

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Adrenergic alpha-Agonists [MoA] MoA All 85 members
Anti-Inflammatory Agents EPC All 251 members
Cyclooxygenase Inhibitors [MoA] MoA All 251 members
Non-Steroidal [CS] CS All 251 members
Nonsteroidal Anti-inflammatory Drug [EPC] EPC All 251 members
alpha-Adrenergic Agonist [EPC] EPC All 85 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
019771
Application type
NDA · New Drug Application
Approval date
September 19, 1989
Sponsor
HALEON US HOLDINGS
Products on application
1
Submissions recorded
24
Products approved under application 019771.
Product Trade name Form Strength Ingredient Status TE Flags
019771-001 ADVIL COLD AND SINUS TABLET IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE Over-the-counter — RLD RS

Therapeutic equivalence

Source: Orange Book
TE code
—
Reference Listed Drug
Yes
Reference Standard
Yes

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Approval history

Source: Drugs@FDA
Most recent submissions on application 019771.
Type No. Action Status Date Review
Supplement 45 Labeling Approved November 19, 2021 Standard
Supplement 40 Labeling Approved March 23, 2017 Standard
Supplement 36 Labeling Approved September 2, 2010 Unknown
Supplement 32 Labeling Approved May 19, 2009 Standard
Supplement 31 Labeling Approved June 20, 2008 Standard
Supplement 26 Labeling Approved April 17, 2006 Standard
Supplement 28 Labeling Approved February 23, 2006 Standard
Supplement 22 Labeling Approved October 17, 2003 Standard
Supplement 21 Manufacturing (CMC) Approved August 2, 2001 Standard
Supplement 20 Labeling Approved May 23, 2001 Standard
Supplement 18 Labeling Approved May 14, 2001 Standard
Supplement 17 Manufacturing (CMC) Approved January 18, 2000 Standard
Supplement 16 Manufacturing (CMC) Approved June 28, 1999 Standard
Supplement 14 Manufacturing (CMC) Approved January 31, 1997 Standard
Supplement 13 Manufacturing (CMC) Approved February 1, 1996 Standard
Supplement 2 Manufacturing (CMC) Approved August 3, 1994 Standard
Supplement 6 Manufacturing (CMC) Approved June 15, 1994 Standard
Supplement 9 Manufacturing (CMC) Approved June 13, 1994 Standard
Supplement 1 Manufacturing (CMC) Approved April 21, 1994 Standard
Supplement 8 Labeling Approved March 11, 1994 Standard
Supplement 4 Labeling Approved May 28, 1992 —
Supplement 7 Labeling Approved September 4, 1991 —
Supplement 3 Manufacturing (CMC) Approved October 17, 1990 Standard
Original application 1 Type 4 - New Combination Approved September 19, 1989 Standard

Review documents

  • 0 · Supplement · November 23, 2021
  • 0 · Supplement · November 23, 2021
  • 0 · Supplement · March 24, 2017
  • 0 · Supplement · March 24, 2017
  • 0 · Supplement · September 7, 2010
  • 0 · Supplement · May 26, 2009
  • 0 · Supplement · June 23, 2008
  • 0 · Supplement · April 20, 2006
  • 0 · Supplement · March 1, 2006
  • 0 · Supplement · October 22, 2003
  • 0 · Supplement · June 10, 2003

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20250613). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20250613

Indications and Usage

openFDA Drug Labeling

USES temporarily relieves these symptoms associated with the common cold or flu: • headache • fever • sinus pressure • nasal congestion • minor body aches and pains

PURPOSES Pain reliever/fever reducer Nasal decongestant

Dosage and Administration

openFDA Drug Labeling

DIRECTIONS • 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

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 • 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 • 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 • 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 • take with food or milk if stomach upset occurs Stop use and ask 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 • 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, 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. In case of overdose, get medical help or contact a Poison Control Center right away.

Do not use • 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

openFDA Drug Labeling

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

Stop use and ask 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 • 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

Active Ingredient

openFDA Drug Labeling

ACTIVE INGREDIENTS (IN EACH CAPLET) Ibuprofen 200 mg (NSAID)* Pseudoephedrine HCl 30 mg *nonsteroidal anti-inflammatory drug

Adverse event reports

Source: openFDA FAERS
283,546
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: IBUPROFEN. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
0573-0180-10 0573-0180 Haleon US Holdings LLC 2 BLISTER PACK in 1 CARTON (0573-0180-10) / 10 TABLET, COATED in 1 BLISTER PACK September 19, 1989
0573-0180-21 0573-0180 Haleon US Holdings LLC 4 BLISTER PACK in 1 CARTON (0573-0180-21) / 10 TABLET, COATED in 1 BLISTER PACK September 19, 1989
0573-0180-80 0573-0180 Haleon US Holdings LLC 2 CARTON in 1 PACKAGE (0573-0180-80) / 4 BLISTER PACK in 1 CARTON / 10 TABLET, COATED in 1 BLISTER PACK May 7, 2025
0573-2160-74 0573-2160 Haleon US Holdings LLC 2 CARTON in 1 PACKAGE (0573-2160-74) / 4 BLISTER PACK in 1 CARTON / 10 TABLET, COATED in 1 BLISTER PACK January 1, 2018
0573-0180 0573-0180 Haleon US Holdings LLC — September 19, 1989
0573-2160 0573-2160 Haleon US Holdings LLC — January 1, 2018

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Drug Labeling FDA / NLM Prescribing information reproduced above
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 11 sections on this page.