FDA-filed SPL labeling · retrieved through openFDA

Chlorpheniramine / Ibuprofen / Pseudoephedrine

Chlorpheniramine, ibuprofen, and pseudoephedrine is a three-ingredient combination used to relieve allergy and cold symptoms including nasal congestion, runny nose, sinus pressure, headache, and minor aches and pains.

Brand name Advil Allergy Sinus
Drug class ⓘ Nonsteroidal Anti-inflammatory Drug
OTC Form 1 Route Oral
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Aug 3, 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 1 clinical label set 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 effectiveMar 23, 2026
AvailabilityOTC
Earliest approval/marketing year ⓘ2002
FDA-listed product records ⓘ4
Boxed warningNone found in compared labels
How we combine label and product data →
⭐ Chlorpheniramine / Ibuprofen / Pseudoephedrine at a glance The quick version — the full detail is in the Patient Information Guide below.
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HelloPharmacist Editorial Team Bottom Line
Advil Allergy Sinus combines an antihistamine, a decongestant, and an NSAID pain reliever to tackle multiple cold and allergy symptoms at once. Use only as directed, and do not exceed the recommended daily amount — the ibuprofen raises real risks for your stomach, heart, and blood vessels if overused. Check with your doctor or pharmacist first if you take other medications, have any ongoing health conditions, or are pregnant.

📖 Chlorpheniramine / Ibuprofen / Pseudoephedrine: Patient Information Guide

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

What Chlorpheniramine / Ibuprofen / Pseudoephedrine is used for

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This combination medication is used to temporarily relieve multiple symptoms of hay fever, other upper respiratory allergies, and the common cold at once.

  • Advil Allergy Sinus relieves runny nose
  • Advil Allergy Sinus relieves sneezing
  • Advil Allergy Sinus relieves itchy, watery eyes
  • Advil Allergy Sinus relieves itching of the nose or throat
  • Advil Allergy Sinus relieves nasal congestion
  • Advil Allergy Sinus relieves sinus pressure
  • Advil Allergy Sinus relieves headache
  • Advil Allergy Sinus relieves minor aches and pains
  • Advil Allergy Sinus reduces fever

How Chlorpheniramine / Ibuprofen / Pseudoephedrine is taken (dosage)

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Advil Allergy Sinus tablets are taken by mouth. Adults take one tablet every 4 to 6 hours while symptoms last, and no more than 6 tablets in a 24-hour period unless a doctor says otherwise. Take with food or milk if the tablet upsets your stomach.

  • Not for children under 12 years of age
  • Use the smallest effective dose for the shortest time needed
  • Always follow the directions on the label or from your prescriber

Chlorpheniramine / Ibuprofen / Pseudoephedrine side effects in detail

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This combination can cause several side effects to be aware of.

  • Drowsiness — the antihistamine chlorpheniramine commonly causes this
  • Stomach upset or discomfort
  • Nervousness or restlessness
  • Dizziness
  • Trouble sleeping (sleeplessness)

Stop use and get medical help right away if you notice signs of serious stomach bleeding (feeling faint, vomiting blood, black or bloody stools) or signs of a heart attack or stroke (chest pain, sudden weakness, slurred speech, trouble breathing).

Chlorpheniramine / Ibuprofen / Pseudoephedrine warnings and precautions

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The most serious warnings involve ibuprofen, the NSAID in this product. NSAIDs can cause severe stomach bleeding — the risk is highest in people over 60, those with a history of ulcers, and those who take blood thinners, steroids, or other NSAIDs. NSAIDs other than aspirin also increase the risk of heart attack, heart failure, and stroke, which can be fatal. Using more than directed or for longer than directed raises these risks further.

  • Ibuprofen may cause a severe allergic reaction — especially in people allergic to aspirin. Signs include hives, facial swelling, wheezing, and blisters.
  • Do not use within 2 weeks of taking an MAOI drug.
  • Do not use right before or after heart surgery.
  • Avoid alcohol — it increases the risk of stomach bleeding and worsens drowsiness.
  • Drowsiness from chlorpheniramine can impair your ability to drive or operate machinery safely.
  • If you are pregnant at 20 weeks or later, do not use ibuprofen unless your doctor specifically tells you to — it can cause problems for the unborn baby or complications during delivery.

Chlorpheniramine / Ibuprofen / Pseudoephedrine interactions: what it interacts with

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This product can interact with several medications, foods, and substances — always check with your pharmacist or doctor before combining it with anything else.

  • MAOIs (drugs for depression, Parkinson's disease, or psychiatric conditions) — do not use this product while taking an MAOI or within 2 weeks of stopping one; the combination can be dangerous
  • Blood thinners (anticoagulants) — raise the risk of serious stomach bleeding when taken with ibuprofen
  • Steroid drugs — increase stomach bleeding risk when combined with ibuprofen
  • Other NSAIDs (aspirin, naproxen, or others) — doubling up raises the risk of side effects and stomach bleeding
  • Aspirin for heart protection — ibuprofen may interfere with aspirin's ability to protect your heart and blood vessels
  • Diuretics (water pills) — ask your doctor before combining with ibuprofen
  • Sedatives and tranquilizers — worsen the drowsiness caused by chlorpheniramine
  • Alcohol — increases both drowsiness and the risk of serious stomach bleeding

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

Before taking Chlorpheniramine / Ibuprofen / Pseudoephedrine

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  • Children under 12 years old should not use this product
  • If you are pregnant, especially at 20 weeks of pregnancy or later, talk to a doctor before using — ibuprofen can harm the unborn baby
  • If you are breastfeeding, ask a health professional before use
  • People age 60 or older face a higher risk of serious stomach bleeding from ibuprofen
  • Talk to your doctor first if you have high blood pressure, heart disease, history of stroke, liver cirrhosis, or kidney disease
  • Talk to your doctor first if you have asthma, emphysema, or chronic bronchitis
  • Talk to your doctor first if you have diabetes, glaucoma, or thyroid disease
  • Talk to your doctor first if you have trouble urinating due to an enlarged prostate gland
  • Talk to your doctor first if you have a history of stomach ulcers, stomach problems, or heartburn
  • Do not use right before or after heart surgery
  • Do not use if you have ever had an allergic reaction to aspirin or any other pain reliever or fever reducer
  • Do not use if you are currently taking a prescription MAOI drug or within 2 weeks of stopping one

Chlorpheniramine / Ibuprofen / Pseudoephedrine overdose: if you take too much

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If you think you or someone else has taken too much of this product, get medical help or contact a Poison Control Center right away — even if no symptoms are present yet. Do not wait for symptoms to appear before seeking help.

📄 Written from Chlorpheniramine / Ibuprofen / Pseudoephedrine’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 →

🩺 Chlorpheniramine / Ibuprofen / Pseudoephedrine: pharmacist answers to common questions

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

What exactly does this medication do — why does it have three ingredients?

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Each ingredient targets a different set of symptoms. Chlorpheniramine is an antihistamine that helps with runny nose, sneezing, and itchy, watery eyes. Pseudoephedrine is a decongestant that opens up stuffed nasal passages and relieves sinus pressure. Ibuprofen is a pain reliever and fever reducer that handles headache, minor aches, and fever. Together, they cover the major miseries of allergies and colds in one tablet.

Will this make me drowsy?

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Yes, chlorpheniramine — the antihistamine — can cause drowsiness. Be careful driving or operating machinery while you're taking it. Alcohol, sedatives, and tranquilizers will make the drowsiness worse, so it's best to avoid those. Some people also feel nervous or have trouble sleeping from the pseudoephedrine — if that happens, stop and check with your doctor.

Is it safe to take this if I'm pregnant?

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You should talk to a doctor before using this product during pregnancy. This is especially important at 20 weeks of pregnancy or later — using ibuprofen at that stage can cause problems for your baby or complications during delivery. If you're breastfeeding, check with a health professional before taking it as well.

What are the most important warning signs I should watch for?

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Stop taking this right away and get medical help if you feel faint, vomit blood, or notice black or bloody stools — these are signs of serious stomach bleeding. Also call 911 immediately for chest pain, sudden weakness on one side of your body, or slurred speech, which can signal a heart attack or stroke. If you develop hives, facial swelling, or wheezing after taking it, that could be a severe allergic reaction and needs emergency care.

Can I take this with my other medications?

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Not always — this product has several important interactions. The biggest one is with MAOI drugs (used for depression or Parkinson's disease): do not use this product if you've taken an MAOI in the past 2 weeks. Blood thinners, steroids, and other NSAIDs like naproxen can increase your risk of stomach bleeding when combined with ibuprofen. If you take aspirin to protect your heart, ibuprofen in this product may weaken that protection. Always check with your pharmacist before combining this with anything else.

How long can I take this, and how much is too much?

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For adults, the maximum is one tablet every 4 to 6 hours — no more than 6 tablets in a 24-hour period, unless a doctor tells you otherwise. If your fever lasts more than 3 days, or your congestion doesn't improve after 7 days, stop and see a doctor. Using more than directed or for longer than directed increases your risk of serious side effects, including stomach bleeding and heart or stroke problems.

Is Chlorpheniramine / Ibuprofen / Pseudoephedrine available over the counter?

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Yes — Chlorpheniramine / Ibuprofen / Pseudoephedrine 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 / Pseudoephedrine first available?

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Chlorpheniramine / Ibuprofen / Pseudoephedrine has been available in the United States since at least 2002, based on FDA approval history (Drugs@FDA) and product marketing records.

Who makes Chlorpheniramine / Ibuprofen / Pseudoephedrine?

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Chlorpheniramine / Ibuprofen / Pseudoephedrine is supplied by 2 manufacturers listed in the FDA NDC Directory, including GlaxoSmithKline Consumer Healthcare Holdings (US) LLC, Haleon US Holdings LLC.

💬 Answers drafted from Chlorpheniramine / Ibuprofen / Pseudoephedrine’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 →

🧰 More about Chlorpheniramine / Ibuprofen / Pseudoephedrine on HelloPharmacist

💊 Chlorpheniramine / Ibuprofen / Pseudoephedrine forms and strengths (how it comes)

Chlorpheniramine / Ibuprofen / Pseudoephedrine 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 Sinus
How this form is used
What it may be used for
  • Advil Allergy Sinus temporarily relieves runny nose, sneezing, and itchy, watery eyes from hay fever or other upper respiratory allergies
  • Advil Allergy Sinus relieves nasal congestion and sinus pressure associated with allergies or the common cold
  • Advil Allergy Sinus relieves headache, minor aches and pains, and fever associated with the common cold or allergies
Important instructions
  • Advil Allergy Sinus: adults take 1 tablet by mouth every 4 to 6 hours while symptoms last
  • Advil Allergy Sinus: do not take more than 6 tablets in any 24-hour period unless directed by a doctor
  • Advil Allergy Sinus: take with food or milk if stomach upset occurs
  • Advil Allergy Sinus: not for children under 12 years of age
Available strengths 1 strength
4 FDA-listed product records ⓘ

📊 Chlorpheniramine / Ibuprofen / Pseudoephedrine on the U.S. market: products, makers and brands

How Chlorpheniramine / Ibuprofen / Pseudoephedrine 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 ⓘ
2
Manufacturers
1
Brand names
4
FDA-listed product records ⓘ
2002
First marketed ⓘ
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC50%
Haleon US Holdings LLC50%

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

🔍 Compare Chlorpheniramine / Ibuprofen / Pseudoephedrine products

A representative set of FDA-listed product records for Chlorpheniramine / Ibuprofen / Pseudoephedrine — 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
2; 200; 30 mg/1; mg/1; mg Oral GlaxoSmithKline Consumer Healthcare Holdings (US) LLC × 2 listings NDA View NDC →
CHLORPHENIRAMINE MALEATE 2 mg/1; IBUPROFEN 200 mg/1; PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg — Haleon US Holdings LLC DRUG FOR FURTHER PROCESSING View NDC →
CHLORPHENIRAMINE MALEATE 2 mg/1; IBUPROFEN 200 mg/1; PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg Oral Haleon US Holdings LLC NDA View NDC →

Showing 4 of 4 products — FDA National Drug Code Directory. See every product, package size and price: browse all 4 Chlorpheniramine / Ibuprofen / Pseudoephedrine 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 / Pseudoephedrine RxCUI 404789 1 dose form · 1 strength

Look up RxCUI 404789 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.

🏷️ Chlorpheniramine / Ibuprofen / Pseudoephedrine brand names

Advil Allergy Sinus

🏭 Who makes Chlorpheniramine / Ibuprofen / Pseudoephedrine: manufacturers and labelers

GlaxoSmithKline Consumer Healthcare Holdings (US) LLC 2 Haleon US Holdings LLC 2

Chlorpheniramine / Ibuprofen / Pseudoephedrine drug class (RxNorm)

Chlorpheniramine / Ibuprofen / Pseudoephedrine 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.

🔬 Sources for this Chlorpheniramine / Ibuprofen / Pseudoephedrine page

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 Mar 23, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Chlorpheniramine / Ibuprofen / Pseudoephedrine.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
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Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Chlorpheniramine / Ibuprofen / Pseudoephedrine after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
1
NDC products indexed
4
Distinct labelers/manufacturers represented
2
Linked representative label ⓘ
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
Linked label effective
Mar 23, 2026
Composite sections available
6
Linked SPL Set ID
ecd6ea11-8b34-01b4-cbd9-901ba7a8f6e2
Linked SPL Document ID
4db54932-2cdf-6aab-e063-6294a90af13f
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 1 FDA-filed SPL label set 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.