FDA-filed SPL labeling · retrieved through openFDA

Cetirizine / Pseudoephedrine

Cetirizine / pseudoephedrine is a combination antihistamine and decongestant used to relieve allergy and congestion symptoms caused by hay fever and other upper respiratory allergies.

Brand names Allergy relief-Dallergy relief dkirkland signature aller tec dall day allergy dZyrtec-d +11 more
Drug classes ⓘ Adrenergic Alpha-agonists
OTC Forms 2 Route Oral
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 17, 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 32 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 12, 2025
Clinical labels in scope ⓘ32
AvailabilityOTC
Earliest approval/marketing year ⓘ2001
FDA-listed product records ⓘ81
Boxed warningNone found in compared labels
How we combine label and product data →
✓No current FDA shortage listed · checked Sep 24, 2026
⭐ Cetirizine / Pseudoephedrine at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Cetirizine / pseudoephedrine combines an antihistamine with a nasal decongestant to tackle both allergy symptoms and congestion together. It can cause drowsiness and is not right for everyone — especially those with high blood pressure, heart disease, or who take MAOIs. Always check with your pharmacist or doctor if you have any ongoing health conditions before starting it.
How we write & review this content — our editorial policy →

📖 Cetirizine / Pseudoephedrine: Patient Information Guide

A plain-language walkthrough of Cetirizine / 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▾

Cetirizine / pseudoephedrine is an oral combination medicine used to relieve both allergy symptoms and nasal congestion caused by hay fever or other upper respiratory allergies.

  • Runny nose
  • Sneezing
  • Itchy, watery eyes
  • Itching of the nose or throat
  • Nasal congestion
  • Swelling of the nasal passages
  • Sinus congestion and pressure
  • Difficulty breathing through the nose
💊How it's taken▾

These products come as extended-release tablets taken by mouth. Adults and children 12 and over take one tablet every 12 hours — no more than 2 tablets in a 24-hour period.

  • Swallow the tablet whole — breaking or chewing it can release too much medication at once
  • Adults 65 and older should ask a doctor before use
  • Children under 12 should not use without a doctor's guidance
  • People with liver or kidney disease should ask a doctor — a different dose may be needed

Follow your specific product label and your prescriber's instructions for guidance on timing and missed doses.

🤒Side effects — in detail▾

This combination can cause a few notable side effects to be aware of:

  • Drowsiness
  • Nervousness
  • Dizziness
  • Trouble sleeping

Stop use and seek medical help right away if you have signs of an allergic reaction. Call a doctor if you feel increasingly nervous, dizzy, or sleepless, or if your symptoms don't improve within 7 days or come with a fever.

⚠️Warnings & precautions▾

The biggest concerns with this combination involve the decongestant, pseudoephedrine. It can raise blood pressure, stress the heart, and overstimulate the nervous system — causing nervousness, dizziness, or insomnia. People with heart disease, high blood pressure, thyroid disease, or diabetes need medical clearance before using it.

  • MAOI interaction: Never use this product if you take an MAOI antidepressant or have taken one in the past 2 weeks — the combination can be dangerous
  • Drowsiness risk: Cetirizine is a sedating antihistamine; alcohol, sedatives, and tranquilizers make drowsiness worse — avoid them while taking this
  • Enlarged prostate: Pseudoephedrine can worsen difficulty urinating in men with an enlarged prostate
  • Glaucoma: Ask a doctor before use if you have glaucoma (elevated pressure in the eye)
  • Pregnancy and breastfeeding: Not recommended while breastfeeding; ask a health professional if pregnant
🔀What it interacts with▾

Several drugs and substances can interact with cetirizine / pseudoephedrine in important ways:

  • MAOIs (monoamine oxidase inhibitors — certain antidepressants and Parkinson's drugs): dangerous interaction; do not combine, and wait at least 2 weeks after stopping an MAOI
  • Alcohol: increases drowsiness — avoid while taking this medication
  • Sedatives and tranquilizers: heighten drowsiness and slow reaction time; check with a doctor or pharmacist before combining

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▾
  • Do not use if you've previously had an allergic reaction to this product, any of its ingredients, or to an antihistamine that contains hydroxyzine
  • Do not use while taking an MAOI drug or within 2 weeks of stopping one
  • Ask a doctor first if you have heart disease, high blood pressure, thyroid disease, or diabetes
  • Ask a doctor first if you have glaucoma (increased eye pressure)
  • Ask a doctor first if you have trouble urinating due to an enlarged prostate gland
  • Ask a doctor first if you have liver or kidney disease — your dose may need to be adjusted
  • Adults 65 and older should consult a doctor before use
  • Not for children under 12 without medical guidance
  • Not recommended while breastfeeding; ask a health professional before use if pregnant
🚑If you take too much▾

In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222. Keep this and all medications out of reach of children.

📦How to store it▾

store between 20° to 25°C (68° to 77°F) do not use if carton is opened or if the blister unit is broken see side panel for batch number and expiration date

📄 Written from Cetirizine / 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 Cetirizine / Pseudoephedrine — 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? ▾
Great question. Cetirizine is an antihistamine that tackles the classic allergy symptoms — the sneezing, runny nose, itchy eyes, and throat irritation. Pseudoephedrine is a decongestant that targets the stuffiness by reducing swelling in the nasal passages and relieving sinus pressure. Together, they cover both sides of allergy congestion in one tablet.
Can this make me feel drowsy? I need to drive. ▾
Yes, drowsiness is a real possibility with this combination. The cetirizine component can make you sleepy, and that effect gets worse if you drink alcohol or take any sedatives or tranquilizers. If you need to drive or operate machinery, be careful until you know how this medicine affects you. Avoid alcohol while you're taking it.
How do I take the tablet — can I cut it in half if it's hard to swallow? ▾
Please don't cut, break, or chew these tablets — swallow them whole. They're extended-release, which means the medication is designed to be released slowly over 12 hours. Breaking the tablet can release too much medicine at once. If swallowing is a challenge, talk to your pharmacist about options.
I take an antidepressant — is it safe to use this? ▾
It depends on the type. If your antidepressant is an MAOI — monoamine oxidase inhibitor — you absolutely cannot take this product. Combining them can cause a serious reaction. Common MAOIs include phenelzine and tranylcypromine, among others. Even if you stopped your MAOI recently, you need to wait at least 2 weeks before taking this. If you're not sure what type of antidepressant you're on, ask your pharmacist before taking this — it only takes a minute and it's important.
I have high blood pressure. Is this safe for me? ▾
You'll want to check with your doctor before using this. The pseudoephedrine (decongestant) in this product can raise blood pressure, which is why people with high blood pressure, heart disease, thyroid disease, or diabetes are advised to get medical clearance first. Your doctor can help decide if this is appropriate for you or if there's a better option.
Can I take this if I'm pregnant or breastfeeding? ▾
If you're breastfeeding, this product is not recommended. If you're pregnant, the label says to ask a health professional before using it. It's always best to check with your doctor or midwife before taking any medication during pregnancy — they can help you weigh the benefits and risks for your specific situation.
Is Cetirizine / Pseudoephedrine available over the counter? ▾
Yes — Cetirizine / 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 Cetirizine / Pseudoephedrine first available? ▾
Cetirizine / Pseudoephedrine has been available in the United States since at least 2001, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Cetirizine / Pseudoephedrine? ▾
Cetirizine / Pseudoephedrine is supplied by 32 manufacturers listed in the FDA NDC Directory, including Walgreen Company, Strategic Sourcing Services LLC, CVS Pharmacy.

💬 Answers drafted from Cetirizine / 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

🌿Drug & Supplement CheckerCetirizine / Pseudoephedrine vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Cetirizine / Pseudoephedrine NDCs & costs 🅰️Browse Drugs A–ZLook up any medication

💊 How Cetirizine / Pseudoephedrine comes

Cetirizine / 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.

Extended-release tablet

By mouth
Brands 12 Hour Allergy D All Day Allergy D Allergy And Congestion Relief D Allergy Relief-D Allergy Relief D allergy relief D12 Equate Allergy Relief D Nasal Decongestant Good Neighbor Pharmacy All Day Allergy D Kirkland Signature Aller Tec D Leader Allergy Relief D Signature Care Allergy Relief D Sunmark All Day Allergy D Topcare All Day Allergy D Wal-Zyr D Wal Zyr D Zyrtec-d
How this form is used
What it may be used for
  • Temporarily relieves runny nose, sneezing, itchy and watery eyes, and itching of the nose or throat due to hay fever or other upper respiratory allergies
  • Relieves nasal congestion and reduces swelling of nasal passages
  • Temporarily relieves sinus congestion and pressure
  • Temporarily restores freer breathing through the nose
Important instructions
  • Swallow the tablet whole — do not break or chew it
  • Adults and children 12 and over: take 1 tablet every 12 hours; no more than 2 tablets in 24 hours
  • Adults 65 and older, children under 12, and people with liver or kidney disease should ask a doctor before use
  • Follow your product label and prescriber's directions carefully
Available strengths 1 strength
5 mg / 120 mg
80 FDA-listed product records ⓘ

Tablet

By mouth
Available strengths 1 strength
5 mg / 120 mg
1 FDA-listed product record ⓘ

📊 Cetirizine / Pseudoephedrine across the U.S. market

How Cetirizine / 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 ⓘ
32
Manufacturers
27
Brand names
81
FDA-listed product records ⓘ
2001
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.

Walgreen Company7%
Strategic Sourcing Services LLC6%
CVS Pharmacy6%
Costco Wholesale Company5%
Rite Aid Corporation5%
Kroger Company5%
Other makers65%

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

📈 How widely Cetirizine / Pseudoephedrine is used

A general measure of how commonly Cetirizine / Pseudoephedrine is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Cetirizine / Pseudoephedrine is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

22,875
Medicaid prescriptions filled (Q1–Q4 2025)
$533,445 gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Cetirizine / Pseudoephedrine prescribed? Of the 1,596 medications we measure, Cetirizine / Pseudoephedrine ranks #779 by Medicaid prescriptions — more than 51% of them.

Where Cetirizine / Pseudoephedrine ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #779 of 1,596
#774 Felbamate 23,708 Rx #775 Mercaptopurine 23,610 Rx #776 Nivolumab Injection 23,499 Rx #777 Fosfomycin 23,298 Rx #778 Valganciclovir 23,219 Rx #779 Cetirizine / Pseudoeph... 22,875 Rx #780 Levetiracetam Injectio... 22,631 Rx #781 Dextromethorphan and Q... 22,121 Rx #782 Ribociclib 21,708 Rx #783 Ambrisentan 21,600 Rx #784 Olopatadine Nasal Spra... 21,523 Rx

Utilization by Cetirizine / Pseudoephedrine product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

12 HR cetirizine hydrochloride 5 MG / pseudoephedrine hydrochloride 120 MG Extended Release Oral Tablet

22,875 Medicaid prescriptions (Q1–Q4 2025) 100% of Cetirizine / Pseudoephedrine prescriptions shown $533,445 gross reimbursement (before rebates) ≈ $23 per prescription (gross)

Summed across the 10 of 104 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1014571

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Cetirizine / Pseudoephedrine, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 10 of 104 listed Cetirizine / Pseudoephedrine NDCs with Medicaid activity.

🔍 Compare Cetirizine / Pseudoephedrine products

A representative set of FDA-listed product records for Cetirizine / 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 81 of 81 products — FDA National Drug Code Directory. See every product, package size and price: browse all 81 Cetirizine / 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) Cetirizine / Pseudoephedrine RxCUI 352367 1 dose form · 1 strength

Look up RxCUI 352367 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

Allergy relief-D allergy relief d kirkland signature aller tec d all day allergy d Zyrtec-d allergy relief D12 Signature Care Allergy Relief D Good Neighbor Pharmacy All Day Allergy D 12 hour allergy d Wal-Zyr D equate allergy relief d nasal decongestant Leader Allergy Relief D Sunmark All Day Allergy D topcare all day allergy d allergy and congestion relief d Wal Zyr D

🏭 Manufacturers & labelers

Walgreen Company 6 Strategic Sourcing Services LLC 5 CVS Pharmacy 5 Costco Wholesale Company 4 Rite Aid Corporation 4 Kroger Company 4 H E B 4 Safeway 3 L. Perrigo Company 3 Publix Super Markets Inc 3 Ohm Laboratories Inc. 3 Aurohealth LLC 3 Meijer Distribution Inc 3 Amerisource Bergen 3 Johnson & Johnson Consumer Inc. 2 Rite Aid 2 Walmart Inc. 2 Kenvue Brands LLC 2 Cardinal Health 110, LLC. dba Leader 2 Sun Pharmaceutical Industries, Inc. 2 Rugby Laboratories 2 A-S Medication Solutions 2 Padagis Israel Pharmaceuticals Ltd 2 Topco Associates LLC 2

…and 8 more on the FDA NDC directory.

RxNorm drug class

Cetirizine / Pseudoephedrine belongs to the Histamine-1 Receptor Antagonist class.

Pharmacologic class Histamine-1 Receptor Antagonist
Drug family (ATC) Piperazine derivatives, Other antiallergics
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 Jun 12, 2025
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Cetirizine / 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 Cetirizine / Pseudoephedrine after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
32
NDC products indexed
81
Distinct labelers/manufacturers represented
32
Linked representative label ⓘ
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
Linked label effective
Jun 12, 2025
Composite sections available
7
Linked SPL Set ID
1e8eb279-3522-40e4-8062-06b5354f0d29
Linked SPL Document ID
375e77b2-d993-5d63-e063-6394a90af43d
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 32 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. Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division 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.