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Advil Allergy and Congestion Relief

chlorpheniramine maleate, ibuprofen, and phenylephrine 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 Allergy and Congestion Relief
Generic name
chlorpheniramine maleate, ibuprofen, and phenylephrine 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
3
NDC product codes
3
Packages
7
Data completeness
77% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Chlorpheniramine Maleate 4 mg/1 1087459 View
Ibuprofen 200 mg/1 310965 View
Phenylephrine Hydrochloride 10 mg/1 1232651 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet, Coated
Route of administration
Oral
Presentations
10

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 alpha1-Agonists [MoA] MoA 9 members — no class page
Anti-Inflammatory Agents EPC All 251 members
Cyclooxygenase Inhibitors [MoA] MoA All 251 members
Histamine H1 Receptor Antagonists [MoA] MoA All 136 members
Histamine-1 Receptor Antagonist [EPC] EPC All 134 members
Non-Steroidal [CS] CS All 251 members
Nonsteroidal Anti-inflammatory Drug [EPC] EPC All 251 members
alpha-1 Adrenergic Agonist [EPC] EPC 9 members — no class page

Regulatory status

Source: Drugs@FDANDC Directory
Application number
022113
Application type
NDA · New Drug Application
Approval date
December 21, 2011
Sponsor
HALEON US HOLDINGS
Products on application
2
Submissions recorded
9
Products approved under application 022113.
Product Trade name Form Strength Ingredient Status TE Flags
022113-001 ADVIL ALLERGY AND CONGESTION RELIEF TABLET CHLORPHENIRAMINE MALEATE; IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE Over-the-counter — RLD RS
022113-002 ADVIL MULTI-SYMPTOM COLD & FLU TABLET CHLORPHENIRAMINE MALEATE; IBUPROFEN; PHENYLEPHRINE 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 022113.
Type No. Action Status Date Review
Supplement 11 Labeling Approved November 23, 2021 Standard
Supplement 8 Labeling Approved September 6, 2019 Standard
Supplement 7 Labeling Approved July 9, 2019 Standard
Supplement 5 Labeling Approved January 25, 2019 Standard
Supplement 4 Labeling Approved February 26, 2018 Standard
Supplement 3 Labeling Approved February 26, 2018 Standard
Supplement 1 Efficacy Approved April 28, 2017 Standard
Supplement 2 Labeling Approved March 24, 2017 Standard
Original application 1 Type 4 - New Combination Approved December 21, 2011 Standard

Review documents

  • 0 · Supplement · November 30, 2021
  • 0 · Supplement · November 24, 2021
  • 0 · Supplement · September 10, 2019
  • 0 · Supplement · September 10, 2019
  • 0 · Supplement · July 10, 2019
  • 0 · Supplement · July 10, 2019
  • 0 · Supplement · February 13, 2019
  • 0 · Supplement · February 6, 2019
  • 0 · Supplement · March 15, 2018
  • 0 · Supplement · March 15, 2018
  • 0 · Supplement · March 1, 2018
  • 0 · Supplement · March 1, 2018
  • 0 · Supplement · May 2, 2017
  • 0 · Supplement · May 1, 2017
  • 0 · Original application · September 6, 2012
  • 0 · Original application · September 6, 2012
  • 0 · Original application · December 28, 2011

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20250409). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20250409 HUMAN OTC DRUG · 20230315

Indications and Usage

openFDA Drug Labeling

Uses • temporarily relieves these symptoms associated with hay fever or other upper respiratory allergies, and the common cold: • runny nose • itchy, watery eyes • itching of the nose or throat • sneezing • nasal congestion • sinus pressure • headache • fever • minor body aches and pains • reduces swelling of the nasal passages • temporarily restores freer breathing through the nose

Purposes Antihistamine Pain reliever/Fever reducer Nasal decongestant

Dosage and Administration

openFDA Drug Labeling

Directions • 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 take 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

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 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 • you have a breathing problem such as emphysema or chronic bronchitis • 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, glaucoma, 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 sedatives or tranquilizers • taking any other product that contains phenylephrine, chlorpheniramine or any other nasal decongestant or antihistamine • 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 • avoid alcoholic drinks • be careful when driving a motor vehicle or operating machinery • drowsiness may occur • alcohol, sedatives, and tranquilizers may increase drowsiness • may cause excitability especially in children 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 • 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 • redness or swelling is present in the painful area • you get nervous, dizzy, or sleepless • symptoms continue or get worse • any new symptoms appear If pregnant or breast-feeding, 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. 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 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

openFDA Drug Labeling

Ask a doctor before use if • you have a breathing problem such as emphysema or chronic bronchitis • 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, glaucoma, 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 • 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 • redness or swelling is present in the painful area • you get nervous, dizzy, or sleepless • symptoms continue or get worse • any new symptoms appear

Active Ingredient

openFDA Drug Labeling

Active ingredients (in each tablet) Chlorpheniramine Maleate 4 mg Ibuprofen 200 mg (NSAID)* Phenylephrine HCl 10 mg *nonsteroidal anti-inflammatory drug Purposes Antihistamine Pain reliever/Fever reducer Nasal decongestant

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.

Recalls

Source: FDA Enforcement
Drug recall enforcement reports associated with this product.
Classification Reported Firm Reason Status
Class II April 1, 2020 Glaxosmithkline Consumer Healthcare Holdings Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel. Terminated

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
0573-0196-01 0573-0196 Haleon US Holdings LLC 50 PACKET in 1 TRAY (0573-0196-01) / 1 TABLET, COATED in 1 PACKET July 23, 2012
0573-0196-02 0573-0196 Haleon US Holdings LLC 2 PACKET in 1 CARTON (0573-0196-02) / 1 TABLET, COATED in 1 PACKET October 1, 2019
0573-0196-10 0573-0196 Haleon US Holdings LLC 1 BLISTER PACK in 1 CARTON (0573-0196-10) / 10 TABLET, COATED in 1 BLISTER PACK July 23, 2012
0573-0196-20 0573-0196 Haleon US Holdings LLC 2 BLISTER PACK in 1 CARTON (0573-0196-20) / 10 TABLET, COATED in 1 BLISTER PACK July 23, 2012
0573-2161-03 0573-2161 Haleon US Holdings LLC 2 BLISTER PACK in 1 CARTON (0573-2161-03) / 10 TABLET, COATED in 1 BLISTER PACK October 1, 2019
67751-149-01 67751-149 Navajo Manufacturing Company Inc. 1 POUCH in 1 CARTON (67751-149-01) / 1 TABLET, COATED in 1 POUCH September 16, 2016
67751-149-02 67751-149 Navajo Manufacturing Company Inc. 2 POUCH in 1 CARTON (67751-149-02) / 1 TABLET, COATED in 1 POUCH September 16, 2016
0573-0196 0573-0196 Haleon US Holdings LLC — July 23, 2012
0573-2161 0573-2161 Haleon US Holdings LLC — July 23, 2012
67751-149 67751-149 Navajo Manufacturing Company Inc. — September 16, 2016

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
Enforcement FDA Recall records

Generated September 25, 2026 · 12 sections on this page.