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ADVIL COLD AND SINUS
ibuprofen and pseudoephedrine hydrochloride · Tablet, Coated
Overview
Active ingredients
Source: NDC DirectoryForms, strengths and routes
Source: NDC DirectoryPharmacologic classes are listed in the class section below.
Pharmacologic class
Source: NDC Directory| 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| 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 BookCodes 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| 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 LabelingReproduced 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.
Indications and Usage
openFDA Drug LabelingUSES temporarily relieves these symptoms associated with the common cold or flu: • headache • fever • sinus pressure • nasal congestion • minor body aches and pains
Purpose
openFDA Drug LabelingPURPOSES Pain reliever/fever reducer Nasal decongestant
Dosage and Administration
openFDA Drug LabelingDIRECTIONS • 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
openFDA Drug LabelingWARNINGS 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
openFDA Drug LabelingDo 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 LabelingAsk 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
openFDA Drug LabelingStop 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 LabelingACTIVE INGREDIENTS (IN EACH CAPLET) Ibuprofen 200 mg (NSAID)* Pseudoephedrine HCl 30 mg *nonsteroidal anti-inflammatory drug
Adverse event reports
Source: openFDA FAERSAttributed 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| 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
| 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.