FDA-filed SPL labeling · retrieved through openFDA

Chlorpheniramine / Ibuprofen / Phenylephrine

Chlorpheniramine, ibuprofen, and phenylephrine is a triple-ingredient combination used to temporarily relieve cold, flu, and allergy symptoms including nasal congestion, runny nose, headache, fever, and body aches.

Brand names Advil Allergy and Congestion ReliefAdvil Multi-Symptom Cold and FluAdvil Allergy Congestion Relief
Drug class ⓘ Nonsteroidal Anti-inflammatory Drug
OTC Form 1 Route Oral
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 4 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

At a glance
Linked label effectiveApr 9, 2025
Clinical labels in scope ⓘ4
AvailabilityOTC
Earliest approval/marketing year ⓘ2012
FDA-listed product records ⓘ14
Boxed warningNone found in compared labels
How we combine label and product data →
✓No current FDA shortage listed · checked Sep 27, 2026
⭐ Chlorpheniramine / Ibuprofen / Phenylephrine at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
This combination tablet treats multiple cold, flu, and allergy symptoms at once — congestion, runny nose, sneezing, headache, body aches, and fever — in adults and children 12 and older. Because it contains ibuprofen (an NSAID), there are important risks including serious stomach bleeding and increased risk of heart attack and stroke, especially with prolonged or excessive use. Use the lowest number of tablets needed, only for as long as symptoms last, and check with your doctor or pharmacist if you have underlying health conditions or take other medications.

📖 Chlorpheniramine / Ibuprofen / Phenylephrine: Patient Information Guide

A plain-language walkthrough of Chlorpheniramine / Ibuprofen / Phenylephrine — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for▾

This combination ingredient page covers three products that treat overlapping but slightly different sets of symptoms.

  • Advil Allergy and Congestion Relief and Advil Allergy Congestion Relief temporarily relieve symptoms of hay fever or other upper respiratory allergies, as well as the common cold: runny nose, itchy and watery eyes, itching of the nose or throat, sneezing, nasal congestion, sinus pressure, headache, minor body aches and pains, and fever.
  • Advil Multi-Symptom Cold and Flu temporarily relieves symptoms of the common cold or flu: headache, fever, minor body aches and pains, nasal congestion, runny nose, sinus pressure, and sneezing.
  • All three products reduce swelling of the nasal passages and temporarily restore freer breathing through the nose.
💊How it's taken▾

All three products come as oral tablets for adults and children 12 years of age and older. Take one tablet every 4 hours while symptoms persist, and do not exceed 6 tablets in a 24-hour period unless your doctor tells you otherwise. Children under 12 should not use any of these products.

  • If the tablet causes stomach upset, take it with food or milk.
  • Do not take more than directed — using more or for longer increases the risk of serious side effects.
🤒Side effects — in detail▾

Like any medication, this combination can cause side effects. Common ones include:

  • Drowsiness
  • Dizziness
  • Nervousness or excitability (especially in children)
  • Sleeplessness
  • Stomach upset

Serious reactions — including signs of stomach bleeding, severe allergic reaction, or heart and stroke symptoms — require you to stop the medication immediately and seek medical help. See the warnings section for details on what to watch for.

⚠️Warnings & precautions▾

Stomach bleeding warning: Ibuprofen is an NSAID and can cause severe stomach bleeding. Your risk is higher if you are 60 or older, have a history of stomach ulcers or bleeding, take blood thinners or steroids, take other NSAIDs, drink 3 or more alcoholic beverages daily, or use more than directed.

Heart attack and stroke warning: NSAIDs (other than aspirin) increase the risk of heart attack, heart failure, and stroke — and these can be fatal. This risk is higher when the product is used in greater amounts or for longer than directed. Additionally, ibuprofen can cause a severe allergic reaction, particularly in people sensitive to aspirin; signs include hives, facial swelling, wheezing, blisters, or shock. Stop use and get emergency help if this happens.

🔀What it interacts with▾

This combination interacts with several medications and substances. Check with your pharmacist or doctor before combining it with:

  • MAOIs (monoamine oxidase inhibitors — drugs for depression, Parkinson's disease, or certain psychiatric conditions): dangerous interaction; do not use together or within 2 weeks of stopping an MAOI.
  • Aspirin for heart or stroke prevention: ibuprofen may reduce the protective effect of aspirin.
  • Other NSAIDs (aspirin, naproxen, and others): raises the risk of serious stomach bleeding.
  • Blood thinners (anticoagulants) or corticosteroids: significantly increases bleeding risk.
  • Diuretics (water pills): ask a doctor before combining.
  • Sedatives or tranquilizers: can intensify drowsiness.
  • Other products with phenylephrine, chlorpheniramine, or any decongestant or antihistamine: risk of doubling up on ingredients.
  • Alcohol: raises stomach bleeding risk and adds to drowsiness.

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it▾
  • Children under 12: do not use any of these products — the dose is too high for this age group.
  • Pregnancy: ask a health professional before use; do not use ibuprofen at 20 weeks or later in pregnancy unless a doctor specifically directs it, as it may harm the unborn child or cause complications during delivery.
  • Breastfeeding: ask a health professional before use.
  • Allergic to aspirin or any pain reliever/fever reducer: do not use.
  • Before or after heart surgery: do not use.
  • Age 60 or older: at higher risk for serious stomach bleeding.
  • History of stomach ulcers, bleeding problems, or heartburn: talk to your doctor first.
  • High blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, thyroid disease, diabetes, glaucoma, or past stroke: ask your doctor before using.
  • Enlarged prostate causing trouble urinating, or breathing problems such as emphysema or chronic bronchitis: ask your doctor first.
  • Taking any other medication: ask a doctor or pharmacist — this combination has several important drug interactions.
🚑If you take too much▾

In case of overdose, get medical help or contact a Poison Control Center right away. Keep these products out of reach of children.

📦How to store it▾

store at 20-25°C (68-77°F) • avoid excessive heat above 40°C (104°F)

📄 Written from Chlorpheniramine / Ibuprofen / Phenylephrine’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

🩺 Pharmacist Counseling Corner

Quick, plain-English answers to the questions patients ask most about Chlorpheniramine / Ibuprofen / Phenylephrine — the kind of thing our pharmacy team would talk through with you at the counter.

What's the difference between Advil Allergy and Congestion Relief and Advil Multi-Symptom Cold and Flu? ▾
The main difference is what they're labeled to treat. Advil Allergy and Congestion Relief (and Advil Allergy Congestion Relief) are meant for allergy symptoms like itchy, watery eyes and a scratchy throat, as well as cold symptoms. Advil Multi-Symptom Cold and Flu is specifically designed for cold and flu symptoms — it doesn't list allergy-specific symptoms like itchy eyes. Both cover the overlap of congestion, runny nose, headache, fever, and body aches.
Can I give this to my child? ▾
No — these products are not for children under 12. The label is clear that the dose in each tablet is too high for younger children. If your child needs relief from cold or allergy symptoms, ask your pharmacist about products specifically formulated for their age.
I'm worried about stomach problems. What should I watch for? ▾
That's a fair concern — ibuprofen can cause serious stomach bleeding in some people. Watch for signs like feeling faint, vomiting blood, stools that are black or look like coffee grounds, or stomach pain that doesn't go away. If any of those happen, stop taking the tablet and see a doctor right away. Taking the tablet with food or milk can help reduce everyday stomach upset, and you should avoid alcohol while using it.
I take a daily aspirin for my heart. Is it okay to use this? ▾
You'll want to check with your doctor before using it. Ibuprofen can actually reduce the heart-protective benefit of your daily aspirin, which is something you really don't want to lose. Your doctor can help you weigh the risks and find the best way to manage your cold or allergy symptoms without interfering with your heart care.
I'm pregnant. Can I use this? ▾
You should talk to your doctor or pharmacist before taking this. The label specifically warns that ibuprofen should NOT be used at 20 weeks of pregnancy or later unless a doctor clearly directs you to, because it can cause problems for the unborn baby or complications during delivery. At any stage of pregnancy, getting professional advice first is the right call.
This makes me really drowsy. Is that normal, and is it safe to drive? ▾
Drowsiness is a known side effect — it comes from the chlorpheniramine (the antihistamine ingredient). The label specifically says to be careful when driving or operating machinery. Alcohol, sedatives, and tranquilizers can make the drowsiness worse. If the drowsiness is affecting your day, talk to your pharmacist about whether a non-drowsy option might work better for you.
Is Chlorpheniramine / Ibuprofen / Phenylephrine available over the counter? ▾
Yes — Chlorpheniramine / Ibuprofen / Phenylephrine is available over the counter (without a prescription) in at least some forms, according to its FDA labeling. Follow the package directions and ask your pharmacist if you're unsure which product is right for you.
When was Chlorpheniramine / Ibuprofen / Phenylephrine first available? ▾
Chlorpheniramine / Ibuprofen / Phenylephrine has been available in the United States since at least 2012, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Chlorpheniramine / Ibuprofen / Phenylephrine? ▾
Chlorpheniramine / Ibuprofen / Phenylephrine is supplied by 4 manufacturers listed in the FDA NDC Directory, including GlaxoSmithKline Consumer Healthcare Holdings (US) LLC, Haleon US Holdings LLC, Navajo Manufacturing Company Inc..

💬 Answers drafted from Chlorpheniramine / Ibuprofen / Phenylephrine’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

💊 How Chlorpheniramine / Ibuprofen / Phenylephrine comes

Chlorpheniramine / Ibuprofen / Phenylephrine is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Tablet

By mouth
Brands Advil Allergy and Congestion Relief Advil Allergy Congestion Relief Advil Multi-Symptom Cold and Flu
How this form is used
What it may be used for
  • Advil Allergy and Congestion Relief and Advil Allergy Congestion Relief: temporarily relieves symptoms of hay fever or other upper respiratory allergies and the common cold, including runny nose, itchy watery eyes, sneezing, nasal congestion, sinus pressure, headache, minor body aches, and fever
  • Advil Multi-Symptom Cold and Flu: temporarily relieves symptoms of the common cold or flu, including headache, fever, minor body aches, nasal congestion, runny nose, sinus pressure, and sneezing
  • All three products help reduce swelling of the nasal passages and temporarily restore freer breathing through the nose
Important instructions
  • Adults and children 12 and older: 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: do not use — Advil Allergy and Congestion Relief, Advil Allergy Congestion Relief, and Advil Multi-Symptom Cold and Flu all contain too much medication for children under this age
  • Take with food or milk if stomach upset occurs
  • Do not take more than directed
Available strengths 1 strength
14 FDA-listed product records ⓘ

📊 Chlorpheniramine / Ibuprofen / Phenylephrine across the U.S. market

How Chlorpheniramine / Ibuprofen / Phenylephrine appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

1
Dose forms ⓘ
4
Manufacturers
3
Brand names
14
FDA-listed product records ⓘ
2012
First marketed ⓘ
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC43%
Haleon US Holdings LLC36%
Navajo Manufacturing Company Inc.14%
Select Corporation7%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

🔍 Compare Chlorpheniramine / Ibuprofen / Phenylephrine products

A representative set of FDA-listed product records for Chlorpheniramine / Ibuprofen / Phenylephrine — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Strength Route Manufacturer / Labeler Category ⓘ Details
💊Tablet
4; 200; 10 mg/1; mg/1; mg Oral GlaxoSmithKline Consumer Healthcare Holdings (US) LLC × 6 listings NDA View NDC →
CHLORPHENIRAMINE MALEATE 4 mg/1; IBUPROFEN 200 mg/1; PHENYLEPHRINE HYDROCHLORIDE 10 mg Oral Haleon US Holdings LLC × 3 listings NDA View NDC →
CHLORPHENIRAMINE MALEATE 4 mg/1; IBUPROFEN 200 mg/1; PHENYLEPHRINE HYDROCHLORIDE 10 mg — Haleon US Holdings LLC × 2 listings DRUG FOR FURTHER PROCESSING View NDC →
CHLORPHENIRAMINE MALEATE 4 mg/1; IBUPROFEN 200 mg/1; PHENYLEPHRINE HYDROCHLORIDE 10 mg Oral Navajo Manufacturing Company Inc. NDA View NDC →
4; 200; 10 mg/1; mg/1; mg Oral Navajo Manufacturing Company Inc. NDA View NDC →
4; 200; 10 mg/1; mg/1; mg Oral Select Corporation OTC MONOGRAPH NOT FINAL View NDC →

Showing 14 of 14 products — FDA National Drug Code Directory. See every product, package size and price: browse all 14 Chlorpheniramine / Ibuprofen / Phenylephrine NDCs →

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one exact multiple-ingredient concept (MIN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). A product with a different ingredient combination belongs on a different page.

Multiple ingredients (MIN) Chlorpheniramine / Ibuprofen / Phenylephrine RxCUI 1310502 1 dose form · 1 strength

Look up RxCUI 1310502 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

🏷️ Sold under these brand names

Advil Allergy and Congestion Relief Advil Multi-Symptom Cold and Flu Advil Allergy Congestion Relief

🏭 Manufacturers & labelers

GlaxoSmithKline Consumer Healthcare Holdings (US) LLC 6 Haleon US Holdings LLC 5 Navajo Manufacturing Company Inc. 2 Select Corporation 1

RxNorm drug class

Chlorpheniramine / Ibuprofen / Phenylephrine belongs to the Histamine-1 Receptor Antagonist class.

Pharmacologic class Histamine-1 Receptor Antagonist
Drug family (ATC) Substituted alkylamines
How it works Histamine H1 Receptor Antagonists

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

🔬 Where this comes from

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Apr 9, 2025
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Chlorpheniramine / Ibuprofen / Phenylephrine.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Chlorpheniramine / Ibuprofen / Phenylephrine after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
4
NDC products indexed
14
Distinct labelers/manufacturers represented
4
Linked representative label ⓘ
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
Linked label effective
Apr 9, 2025
Composite sections available
7
Linked SPL Set ID
a6cc97d8-252a-4527-a470-6d9e356342fd
Linked SPL Document ID
ac233de1-41cf-4ef0-a7b4-30f395c88c1a
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 4 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. GlaxoSmithKline Consumer Healthcare Holdings (US) LLC is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.