Ibuprofen / Phenylephrine
Ibuprofen / Phenylephrine is a combination pain reliever and nasal decongestant used across multiple products to treat headache, fever, sinus pressure, nasal congestion, and minor body aches associated with the common cold or flu.
🧬 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 7 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 →
📖 Ibuprofen / Phenylephrine: Patient Information Guide
A plain-language walkthrough of 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▾
Ibuprofen / Phenylephrine products are used to relieve multiple cold and flu symptoms at once. The following uses are supported across the available products:
- Temporarily relieves headache associated with the common cold or flu
- Reduces fever
- Relieves sinus pressure
- Relieves nasal congestion
- Eases minor body aches and pains
- Reduces swelling of the nasal passages
- Temporarily restores freer breathing through the nose
💊How it's taken▾
All supported products are taken by mouth. Adults and children 12 and older take one tablet (or caplet, in the case of Sudafed PE Head Congestion Plus Pain) every 4 hours while symptoms persist.
- Do not take more than 6 tablets or caplets in any 24-hour period unless a doctor says otherwise
- Children under 12 should not use any of these products
- If your stomach gets upset, take the tablet with food or milk
Always follow the directions on the specific product you are using, and check with your prescriber or pharmacist if you have questions about your regimen.
🤒Side effects — in detail▾
These products can cause some side effects, though not everyone experiences them. Common ones to be aware of include:
- Stomach upset or nausea
- Nervousness or feeling jittery
- Dizziness
- Trouble sleeping
- Skin rash or redness
More serious reactions — including signs of stomach bleeding (vomiting blood, black or bloody stools, stomach pain that won't go away), severe allergic reactions (hives, facial swelling, wheezing, blisters), or signs of a heart attack or stroke (chest pain, trouble breathing, sudden weakness, slurred speech) — require you to stop use immediately and get emergency medical help.
⚠️Warnings & precautions▾
- Heart attack and stroke risk: NSAIDs like ibuprofen (except aspirin) can increase the risk of heart attack, heart failure, and stroke — including fatal events. This risk is higher when used above the recommended dose or for longer than directed.
- Serious stomach bleeding: This product can cause severe stomach bleeding. Risk is higher in people 60 or older, those with a history of ulcers or bleeding, people taking blood thinners or steroids, those using other NSAIDs, and people who drink 3 or more alcoholic beverages daily.
- Severe allergic reactions: Ibuprofen can trigger a serious allergic reaction — especially in people allergic to aspirin. Signs include hives, facial swelling, wheezing, blistering, rash, or shock. Stop use and get emergency help if these occur.
- Do not use before or after heart surgery.
- Pregnancy: Avoid ibuprofen during the last 3 months of pregnancy unless a doctor specifically directs its use — it can cause problems for the unborn baby or complications during delivery.
🔀What it interacts with▾
This combination can interact with several drugs and substances. Check with your doctor or pharmacist before combining it with:
- MAOIs (monoamine oxidase inhibitors) — used for depression or Parkinson's disease: do not take together or within 2 weeks of stopping an MAOI
- Aspirin taken to prevent heart attack or stroke: ibuprofen may reduce aspirin's protective effect
- Blood thinners (anticoagulants) and steroid drugs: raise the risk of serious stomach bleeding
- Other NSAIDs (naproxen, other ibuprofen products, aspirin as a pain reliever): increases stomach bleeding risk
- Other phenylephrine products or nasal decongestants: do not use together
- Diuretics (water pills): ask a doctor before combining
- Alcohol: 3 or more drinks per day while using this product significantly raises stomach bleeding risk
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 should not use these products — the dose is too high for them
- Tell your doctor if you have or have had stomach ulcers, stomach bleeding, or heartburn
- Ask a doctor first if you have high blood pressure, heart disease, or a history of stroke
- Ask a doctor first if you have liver cirrhosis or kidney disease
- Ask a doctor first if you have asthma, thyroid disease, or diabetes
- Ask a doctor first if you have an enlarged prostate gland that makes urinating difficult
- If you are pregnant — especially in the last 3 months — ask a health professional before use
- If you are breastfeeding, ask a health professional before use
- Tell your pharmacist about all prescription and over-the-counter drugs you take before using this product
🚑If you take too much▾
If you or someone else takes too much of this product, get medical help or contact Poison Control right away at 1-800-222-1222. Act quickly — do not wait for symptoms to appear.
📦How to store it▾
store between 20-25°C (68-77°F). Avoid excessive heat above 40°C (104°F).
📄 Written from 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 Ibuprofen / Phenylephrine — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly does this medicine do — why does it have two ingredients? ▾
How often can I take it, and is there a maximum per day? ▾
Should I take it with food? ▾
I take a baby aspirin every day for my heart — is it okay to use this? ▾
I'm pregnant — can I take this? ▾
What side effects should make me stop and call for help? ▾
Is Ibuprofen / Phenylephrine available over the counter? ▾
When was Ibuprofen / Phenylephrine first available? ▾
Who makes Ibuprofen / Phenylephrine? ▾
💬 Answers drafted from 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 Ibuprofen / Phenylephrine comes
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
How this form is used
- Temporarily relieves headache, fever, sinus pressure, nasal congestion, and minor body aches associated with the common cold or flu
- Reduces swelling of the nasal passages and temporarily restores freer breathing through the nose
- Advil Sinus Congestion And Pain, Advil Sinus Congestion and Pain Relief: adults and children 12 and over take 1 coated tablet every 4 hours while symptoms persist; do not exceed 6 tablets in 24 hours unless directed by a doctor
- Sudafed PE Head Congestion Plus Pain: adults and children 12 and over take 1 caplet every 4 hours while symptoms persist; do not exceed 6 caplets in 24 hours unless directed by a doctor
- Congestion Relief and Equaline congestion relief: adults and children 12 and over take 1 film-coated tablet every 4 hours while symptoms persist; do not exceed 6 tablets in 24 hours unless directed by a doctor
- Take with food or milk if stomach upset occurs; do not use in children under 12
📊 Ibuprofen / Phenylephrine across the U.S. market
How 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.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
🔍 Compare Ibuprofen / Phenylephrine products
A representative set of FDA-listed product records for 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 | ||||
| 200; 10 mg/1; mg | Oral | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC × 2 listings | NDA | View NDC → |
| IBUPROFEN 200 mg/1; PHENYLEPHRINE HYDROCHLORIDE 10 mg | — | Haleon US Holdings LLC | DRUG FOR FURTHER PROCESSING | View NDC → |
| IBUPROFEN 200 mg/1; PHENYLEPHRINE HYDROCHLORIDE 10 mg | Oral | Haleon US Holdings LLC | NDA | View NDC → |
| IBUPROFEN 200 mg/1; PHENYLEPHRINE HYDROCHLORIDE 10 mg | Oral | H E B | ANDA | View NDC → |
| 200; 10 mg/1; mg | Oral | Johnson & Johnson Consumer Inc. | ANDA | View NDC → |
| 200; 10 mg/1; mg | Oral | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | ANDA | View NDC → |
| IBUPROFEN 200 mg/1; PHENYLEPHRINE HYDROCHLORIDE 10 mg | Oral | Kenvue Brands LLC | ANDA | View NDC → |
| IBUPROFEN 200 mg/1; PHENYLEPHRINE HYDROCHLORIDE 10 mg | Oral | Meijer Distribution Inc | ANDA | View NDC → |
| IBUPROFEN 200 mg/1; PHENYLEPHRINE HYDROCHLORIDE 10 mg | Oral | Navajo Manufacturing Company Inc. | NDA | View NDC → |
| 200; 10 mg/1; mg | Oral | Navajo Manufacturing Company Inc. | NDA | View NDC → |
| 200; 10 mg/1; mg | Oral | Rite Aid Corporation | ANDA | View NDC → |
| 200; 10 mg/1; mg | Oral | Select Corporation | NDA | View NDC → |
| 200; 10 mg/1; mg | Oral | Supervalu Inc | ANDA | View NDC → |
| IBUPROFEN 200 mg/1; PHENYLEPHRINE HYDROCHLORIDE 10 mg | Oral | United Natural Foods, Inc. dba UNFI | ANDA | View NDC → |
| 200; 10 mg/1; mg | Oral | Walgreen Company | ANDA | View NDC → |
Showing 16 of 16 products — FDA National Drug Code Directory. See every product, package size and price: browse all 16 Ibuprofen / Phenylephrine NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Ibuprofen / Phenylephrine — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Ibuprofen / Phenylephrine in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Ibuprofen / Phenylephrine went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
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.
RxCUI 1007329 1 dose form · 1 strength
-
Dose form (SCDF) Oral Tablet RxCUI 993798In current FDA listingsClinical drug / strength (SCD) ibuprofen 200 MG / phenylephrine hydrochloride 10 MGRxCUI 1369775
Look up RxCUI 1007329 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.
📦 Supply & shortage status
Whether Ibuprofen / Phenylephrine is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Ibuprofen / Phenylephrine belongs to the Nonsteroidal Anti-inflammatory Drug class.
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.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 7 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.