FDA-filed SPL labeling · retrieved through openFDA

Ibuprofen / Pseudoephedrine

Ibuprofen/pseudoephedrine combines a pain reliever and fever reducer with a nasal decongestant to temporarily relieve common cold and flu symptoms.

Brand name Advil Cold And Sinus
Drug class ⓘ Nonsteroidal Anti-inflammatory Drug
Rx/OTC Forms 2 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 17 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 effectiveJun 13, 2025
Clinical labels in scope ⓘ17
AvailabilityRx/OTC
Earliest approval/marketing year ⓘ1989
FDA-listed product records ⓘ42
Boxed warningNone found in compared labels
How we combine label and product data →
✓No current FDA shortage listed · checked Sep 27, 2026
⭐ Ibuprofen / Pseudoephedrine at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Ibuprofen/pseudoephedrine is a useful short-term combination for tackling cold and flu symptoms like congestion, headache, fever, and body aches all at once. Use the lowest effective dose, take it with food if your stomach is sensitive, and don't use it for more than a week without talking to your doctor. People with heart disease, high blood pressure, kidney or liver problems, or those on certain medications — especially MAOIs or blood thinners — should get medical guidance before using it.
How we write & review this content — our editorial policy →

📖 Ibuprofen / Pseudoephedrine: Patient Information Guide

A plain-language walkthrough of Ibuprofen / Pseudoephedrine — 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▾

Ibuprofen/pseudoephedrine is approved to temporarily relieve multiple common cold and flu symptoms at the same time in adults and children 12 and older.

  • Headache
  • Fever
  • Sinus pressure
  • Nasal congestion
  • Minor body aches and pains
💊How it's taken▾

This medication is taken by mouth. Both tablet and capsule forms are taken every 4 to 6 hours while symptoms last. If one dose isn't enough, two may be taken — but always start with the lower amount and use the smallest dose that works.

  • Do not take more than 6 tablets or capsules in any 24-hour period unless a doctor directs otherwise
  • Children under 12 years of age should not use this product
  • If your stomach feels upset, take it with food or milk
  • Follow your product's label directions carefully — do not take more or for longer than directed
🤒Side effects — in detail▾

Most people tolerate this medication well at recommended doses, but some side effects can occur.

  • Stomach upset or discomfort
  • Feeling nervous or jittery
  • Dizziness
  • Trouble sleeping
  • Nausea

Stop use and get medical help right away if you notice signs of serious stomach bleeding (vomiting blood, black or bloody stools, severe stomach pain) or symptoms of a heart problem or stroke (chest pain, sudden weakness, slurred speech, trouble breathing, or leg swelling). A serious allergic reaction — hives, facial swelling, wheezing, or blistering skin — requires emergency care.

⚠️Warnings & precautions▾
  • Heart attack and stroke risk: NSAIDs (like ibuprofen) — except aspirin — increase the risk of heart attack, heart failure, and stroke, which can be fatal. This risk is higher if you take more than directed or for longer than directed.
  • Stomach bleeding: This product can cause serious stomach bleeding. Your risk is higher if you are 60 or older, have had ulcers, use blood thinners or steroids, take other NSAIDs, or drink 3 or more alcoholic beverages daily.
  • Severe allergic reaction: Ibuprofen can cause a serious allergic reaction, especially in people who are allergic to aspirin. Symptoms include hives, facial swelling, wheezing, shock, skin reddening, rash, or blisters.
  • MAOI interaction: Do not use this product if you are currently taking or have taken an MAOI drug within the last 2 weeks — this can cause a dangerous drug interaction.
  • Pregnancy: Do not use ibuprofen during the last 3 months of pregnancy unless your doctor specifically tells you to — it may harm your unborn baby or cause delivery complications.
  • Heart surgery: Do not use right before or right after heart surgery.
🔀What it interacts with▾

This product can interact with several common drugs and substances — always tell your doctor or pharmacist what you're taking.

  • MAOIs (certain antidepressants, Parkinson's medications): dangerous interaction — do not use together or within 2 weeks of stopping an MAOI
  • Blood thinners (anticoagulants): raises the risk of serious stomach bleeding
  • Steroid drugs: also increases stomach bleeding risk
  • Aspirin (taken for heart protection): ibuprofen may block aspirin's heart-protecting effect
  • Other NSAIDs (naproxen, aspirin as a pain reliever, etc.): stacking NSAIDs raises the risk of side effects and bleeding
  • Other decongestants or pseudoephedrine products: don't use together — too much decongestant can be harmful
  • Diuretics (water pills): check with your doctor before combining
  • Alcohol: three or more drinks a day while using this product significantly increases the risk of 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 it▾
  • Children under 12 years of age: do not use
  • Adults 60 or older: higher risk of stomach bleeding — use with caution
  • Anyone with a history of stomach ulcers, bleeding problems, or heartburn: talk to your doctor first
  • People with high blood pressure, heart disease, liver cirrhosis (scarring of the liver), kidney disease, asthma, thyroid disease, or diabetes: ask a doctor before use
  • People who have had a stroke or have trouble urinating due to an enlarged prostate gland: ask a doctor first
  • People taking aspirin for heart or stroke prevention: ibuprofen may reduce that benefit — check with your doctor
  • People taking any MAOI drug: do not use this product
  • Anyone allergic to aspirin or any other pain reliever or fever reducer: do not use
  • Pregnant individuals: do not use during the last 3 months of pregnancy without direct doctor guidance; ask a health professional at any stage
  • Breastfeeding: ask a health professional before use
  • Do not use right before or after heart surgery
🚑If you take too much▾

If you think you or someone else has taken too much of this medication, get medical help or contact a Poison Control Center right away — call 1-800-222-1222. Don't wait for symptoms to appear before calling.

📦How to store it▾

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

📄 Written from 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 →

🩺 Pharmacist Counseling Corner

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

What exactly does this medication do, and when should I use it? ▾
It combines ibuprofen — a pain reliever and fever reducer — with pseudoephedrine, a nasal decongestant. Together they tackle multiple cold and flu symptoms at once: headache, fever, sinus pressure, nasal congestion, and body aches. It's meant for short-term symptom relief, not treating the infection itself.
Should I take it with food? ▾
You don't have to, but if your stomach feels upset after taking it, try taking it with food or milk. That simple step can make a big difference in tolerability, especially if your stomach is sensitive.
How long can I keep taking it before I need to call a doctor? ▾
If your fever lasts more than 3 days or your nasal congestion sticks around longer than 7 days, stop taking it and call your doctor — those can be signs of something that needs more than an OTC cold remedy. Also call if your symptoms get worse instead of better.
I take a blood thinner — is it safe for me to use this? ▾
You should check with your doctor or pharmacist before using this. The ibuprofen in this product can raise your risk of serious stomach bleeding when combined with blood thinners. Your doctor may recommend a different option to manage your cold symptoms safely.
Can I take this if I'm pregnant? ▾
It's especially important not to use ibuprofen during the last 3 months of pregnancy — it can cause problems for your unborn baby or complications during delivery. At any stage of pregnancy, check with your doctor or midwife before taking it. The same goes if you're breastfeeding.
I'm also taking an antidepressant. Is that a problem? ▾
It could be. Certain antidepressants called MAOIs can interact dangerously with pseudoephedrine. Don't use this product if you're taking an MAOI or have stopped one in the past 2 weeks. If you're not sure whether your antidepressant is an MAOI, ask your pharmacist before taking this — we're happy to check.
Is Ibuprofen / Pseudoephedrine available over the counter? ▾
Both — Ibuprofen / Pseudoephedrine is sold both over the counter and by prescription, according to its FDA labeling. Lower strengths or certain forms are often available without a prescription, while higher strengths or specialized forms still require one. Ask your pharmacist which version is right for you.
When was Ibuprofen / Pseudoephedrine first available? ▾
Ibuprofen / Pseudoephedrine has been available in the United States since at least 1989, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Ibuprofen / Pseudoephedrine? ▾
Ibuprofen / Pseudoephedrine is supplied by 19 manufacturers listed in the FDA NDC Directory, including Haleon US Holdings LLC, Ohm Laboratories Inc., GlaxoSmithKline Consumer Healthcare Holdings (US) LLC.

💬 Answers drafted from 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 →

🧰 Keep exploring

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💊 How Ibuprofen / Pseudoephedrine comes

Ibuprofen / Pseudoephedrine is available in 2 forms. 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 Cold And Sinus
How this form is used
What it may be used for
  • Advil Cold And Sinus tablets temporarily relieve headache, fever, sinus pressure, nasal congestion, and minor body aches and pains associated with the common cold or flu
  • Ibuprofen and Pseudoephedrine hydrochloride tablets temporarily relieve headache, fever, sinus pressure, nasal congestion, and minor body aches and pains associated with the common cold or flu
Important instructions
  • Advil Cold And Sinus tablets: adults and children 12 and over take 1 tablet every 4 to 6 hours while symptoms last; 2 tablets may be used if 1 is not enough — do not exceed 6 tablets in 24 hours
  • Ibuprofen and Pseudoephedrine hydrochloride tablets: adults and children 12 and over take 1 tablet every 4 to 6 hours; 2 may be used if needed — do not exceed 6 tablets in 24 hours
  • Children under 12 should not use either tablet product
  • Take with food or milk if stomach upset occurs; always use the smallest effective dose
Available strengths 1 strength
200 mg / 30 mg
28 FDA-listed product records ⓘ

Capsule

By mouth
Brands Advil Cold And Sinus
How this form is used
What it may be used for
  • Advil Cold And Sinus capsules temporarily relieve headache, fever, sinus pressure, nasal congestion, and minor body aches and pains associated with the common cold or flu
  • Ibuprofen and Pseudoephedrine HCl capsules temporarily relieve headache, sinus pressure, nasal congestion, minor body aches and pains, and fever associated with the common cold or flu
Important instructions
  • Advil Cold And Sinus capsules: adults and children 12 and over take 1 capsule every 4 to 6 hours while symptoms last; 2 capsules may be used if 1 is not enough — do not exceed 6 capsules in 24 hours
  • Ibuprofen and Pseudoephedrine HCl capsules: adults and children 12 and over take 1 capsule every 4 to 6 hours; 2 may be used if needed — do not exceed 6 capsules in 24 hours
  • Children under 12 should not use either capsule product
  • Take with food or milk if stomach upset occurs; use the smallest effective dose
Available strengths 1 strength
200 mg / 30 mg
14 FDA-listed product records ⓘ

📊 Ibuprofen / Pseudoephedrine across the U.S. market

How 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.

2
Dose forms ⓘ
19
Manufacturers
3
Brand names
42
FDA-listed product records ⓘ
1989
First marketed ⓘ

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Haleon US Holdings LLC12%
Ohm Laboratories Inc.12%
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC7%
The Kroger Company7%
Aurohealth LLC7%
Walgreen Co.5%
Other makers50%

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

🔍 Compare Ibuprofen / Pseudoephedrine products

A representative set of FDA-listed product records for 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.)

Showing 42 of 42 products — FDA National Drug Code Directory. See every product, package size and price: browse all 42 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) Ibuprofen / Pseudoephedrine RxCUI 214652 3 dose forms · 4 strengths
  2. Dose form (SCDF) Oral Suspension RxCUI 370677 No current FDA listing
    Clinical drug / strength (SCD) ibuprofen 20 MG/ML / pseudoephedrine hydrochloride 3 MG/ML RxCUI 1310487

Look up RxCUI 214652 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 Cold And Sinus

🏭 Manufacturers & labelers

Haleon US Holdings LLC 5 Ohm Laboratories Inc. 5 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC 3 The Kroger Company 3 Aurohealth LLC 3 Walgreen Co. 2 Cardinal Health 2 CVS Pharmacy, Inc. 2 Bryant Ranch Prepack 2 Strategic Sourcing Services LLC 2 CVS Pharmacy 2 Publix Super Markets Inc 2 Rite-Aid 2 Walgreen Company 2 Amerisource Bergen 1 Cardinal Health 110, Llc Dba Leader 1 Aurobindo Pharma Limited 1 Cardinal Health 110, Llc. Dba Leader 1 Catalent Pharma Solutions, LLC 1

RxNorm drug class

Ibuprofen / Pseudoephedrine belongs to the Nonsteroidal Anti-inflammatory Drug class.

Pharmacologic class Nonsteroidal Anti-inflammatory Drug
Drug family (ATC) Other cardiac preparations, Antiinflammatory products for vaginal administration, Propionic acid derivatives
How it works Cyclooxygenase Inhibitors

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 Jun 13, 2025
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Ibuprofen / Pseudoephedrine.
📈
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 Ibuprofen / Pseudoephedrine after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
17
NDC products indexed
42
Distinct labelers/manufacturers represented
19
Linked representative label ⓘ
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
Linked label effective
Jun 13, 2025
Composite sections available
7
Linked SPL Set ID
fac22a47-f0de-4505-fd8a-768430cda0c1
Linked SPL Document ID
cec76100-19bc-49c3-8805-7badb2a8bf28
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 17 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.