Quick answers
- What is Chlorpheniramine, ibuprofen and phenylephrine used for?
- The Drug Facts label of Advil Allergy and Congestion Relief (Haleon US Holdings LLC) lists these 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; minor body aches and pains; fever; reduces swelling of the nasal passages; temporarily restores freer breathing through the nose.
- Do I need a prescription for Chlorpheniramine, ibuprofen and phenylephrine?
- No. The products on this page are sold without a prescription (over the counter).
- Is a store brand the same as the name brand?
- Products listed together below have the same active ingredients, in the same amount and the same form, as registered with the FDA. Inactive ingredients (such as colors, flavors and fillers) and package sizes can differ. Compare the “Active ingredient” box on both packages, and ask a pharmacist if you are not sure.
- Has Chlorpheniramine, ibuprofen and phenylephrine been recalled?
- FDA enforcement reports list 2 recalls of products on this page; the newest started March 16, 2020. A recall usually concerns specific products or lots, not every brand.
Drug Facts label
Every over-the-counter medicine must carry a “Drug Facts” box in the same order, set by FDA rules. Below is the label of one product for each common strength and form, quoted word for word. Your own package can differ (for example, children’s products have other directions): always follow the label on your package.
Advil Allergy and Congestion Relief · Haleon US Holdings LLC
Chlorpheniramine maleate 4 mg · Ibuprofen 200 mg · Phenylephrine hydrochloride 10 mg, tablet, coated (oral)
Active ingredient (in each tablet)
Chlorpheniramine maleate 4 mg Ibuprofen 200 mg (NSAID)* Phenylephrine HCl 10 mg * nonsteroidal anti-inflammatory drug
Purpose
Antihistamine Pain reliever/Fever reducer Nasal decongestant
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
- minor body aches and pains
- fever
- reduces swelling of the nasal passages
- temporarily restores freer breathing through the nose
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.
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
Inactive ingredients
acesulfame potassium, artificial flavors, carnauba wax, colloidal silicon dioxide, corn starch, croscarmellose sodium, glycerin, glyceryl dibehenate, hypromellose, lactic acid, lecithin, maltodextrin, medium-chain triglycerides, microcrystalline cellulose, pharmaceutical ink, polydextrose, polyvinyl alcohol, pregelatinized starch, propyl gallate, silicon dioxide, sucralose, synthetic iron oxide, talc, titanium dioxide, triacetin, xanthan gum
Questions?
Call weekdays from 9 AM to 5 PM EST toll free at 1-800-88-ADVIL
— FDA label of Advil Allergy and Congestion Relief, Haleon US Holdings LLC, effective April 9, 2025. See the official label on DailyMed →
This page is not medical advice. Read the label on your package, and ask a pharmacist or doctor if you are not sure a medicine is right for you, for your child, or with your other medicines.
Same medicine, other brands
Each group lists the products that have exactly the same active ingredients, in the same amount and form, as registered with the FDA (NDC Directory). A store brand in the same group has the same medicine as the name brand; inactive ingredients, flavors and package sizes can differ. Each product links to its own official label.
Chlorpheniramine maleate 4 mg · Ibuprofen 200 mg · Phenylephrine hydrochloride 10 mg · tablet, coated (oral) · 4 products
Drug Facts for this strength and form ↑
| Brand or product name | Company on the label | Label |
|---|---|---|
| Advil Allergy and Congestion Relief | Haleon US Holdings LLC | DailyMed |
| Advil Allergy and Congestion Relief | Navajo Manufacturing Company Inc. | DailyMed |
| Advil Multi-Symptom Cold and Flu | Haleon US Holdings LLC | DailyMed |
Companies that sell this medicine
The company named on the package (maker or distributor), as listed in the FDA NDC Directory, with its number of over-the-counter products of this medicine.
- Haleon US Holdings LLC3 products
- Navajo Manufacturing Company Inc.1 product
Recalls
From FDA enforcement reports, matched by the product’s NDC code or label. A recall usually covers specific products or lots: check the name and lot number on your package.
-
March 16, 2020 · Class II · Terminated · D-1068-2020
Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.
Advil Sinus Congestion and Pain/Advil Allergy and Congestion Relief 8 pc with $1 IRC (mixed product display - only Advil Allergy & Congestion is impacted). NDC # 0573-2161-14 SKU# F00573216114A (original lot # R73995) Co — Glaxosmithkline Consumer Healthcare Holdings
-
March 16, 2020 · Class II · Terminated · D-1065-2020
Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.
Ibuprofen 200 mg Chlorpheniramine Maleate 4mg Phenylephrine 10 mg tablets. Advil Allergy & Congestion Relief 10 and 20 count blister tray in carton NDC 0573-0196-10, item # F00573019610C, 10 ct. blister NDC 0573-0196-20, — Glaxosmithkline Consumer Healthcare Holdings
Sources
- Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- FDA rule for the Drug Facts label (21 CFR 201.66)
Only medicines marketed under FDA rules for nonprescription drugs (an FDA monograph or an FDA approval) are listed. Homeopathic products are not listed: the FDA does not evaluate them for safety or effectiveness.