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Advil Allergy and Congestion Relief
chlorpheniramine maleate, ibuprofen, and phenylephrine 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 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| 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 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 | 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 LabelingReproduced 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.
Indications and Usage
openFDA Drug LabelingUses • 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
Purpose
openFDA Drug LabelingPurposes Antihistamine Pain reliever/Fever reducer Nasal decongestant
Dosage and Administration
openFDA Drug LabelingDirections • 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
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 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
openFDA Drug LabelingDo 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 LabelingAsk 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
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 • 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 LabelingActive 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 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.
Recalls
Source: FDA Enforcement| 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| 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
| 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.