FDA-filed SPL labeling · retrieved through openFDA

Loratadine / Pseudoephedrine

Loratadine / Pseudoephedrine is a combination antihistamine and nasal decongestant used to relieve allergy symptoms and nasal congestion from hay fever, other upper respiratory allergies, and the common cold.

Brand names Allergy Relief DClaritin-Dallergy relief d 12Allergy Relief-DAllergy and Congestion Relief +11 more
Drug classes ⓘ Adrenergic Alpha-agonists
OTC Form 1 Route Oral
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 19, 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 50 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 effectiveDec 5, 2025
Clinical labels in scope ⓘ50
AvailabilityOTC
Earliest approval/marketing year ⓘ2003
FDA-listed product records ⓘ100
Boxed warningNone found in compared labels
How we combine label and product data →
✓No current FDA shortage listed · checked Sep 25, 2026
⭐ Loratadine / Pseudoephedrine at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Loratadine / Pseudoephedrine is a convenient combination that tackles both allergy symptoms and nasal congestion in one extended-release tablet. Always swallow the tablet whole, never exceed the recommended daily limit for your specific product, and check with your doctor or pharmacist before use if you have heart disease, high blood pressure, diabetes, or are taking any other medications — especially MAOIs.
How we write & review this content — our editorial policy →

📖 Loratadine / Pseudoephedrine: Patient Information Guide

A plain-language walkthrough of Loratadine / 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▾

Loratadine / Pseudoephedrine combines an antihistamine and a decongestant to address both allergy symptoms and nasal congestion. Supported uses across the product family include:

  • Temporarily relieves sneezing due to hay fever or other upper respiratory allergies
  • Temporarily relieves itchy, watery eyes due to hay fever or other upper respiratory allergies
  • Temporarily relieves runny nose due to hay fever or other upper respiratory allergies
  • Temporarily relieves itching of the nose or throat due to hay fever or other upper respiratory allergies
  • Temporarily relieves nasal congestion due to the common cold, hay fever, or other upper respiratory allergies
  • Reduces swelling of the nasal passages
  • Temporarily relieves sinus congestion and pressure
  • Temporarily restores freer breathing through the nose
💊How it's taken▾

These extended-release tablets are taken by mouth with a full glass of water. Never divide, crush, chew, or dissolve the tablet — doing so can release too much medicine at once.

  • 12-hour products (such as Alavert extended-release tablets): 1 tablet every 12 hours; no more than 2 tablets in 24 hours
  • 24-hour products (such as Allergy Relief-D and allergy congestion relief extended-release tablets): 1 tablet once daily; no more than 1 tablet in 24 hours
  • Children under 12, and people with liver or kidney disease, should ask a doctor before use

Always follow the directions on your specific product's label or as directed by your prescriber.

🤒Side effects — in detail▾

Most people tolerate this combination well at the recommended dose, but some side effects can occur:

  • Drowsiness (more likely if you take more than directed)
  • Nervousness
  • Dizziness
  • Sleeplessness or difficulty sleeping

Stop use and get medical help right away if you have signs of an allergic reaction. Call your doctor if nervousness, dizziness, or sleeplessness develops, or if symptoms don't improve within 7 days or come with a fever.

⚠️Warnings & precautions▾
  • MAOI interaction: Do not take this product if you are using — or have used within the past 2 weeks — a prescription MAOI (monoamine oxidase inhibitor). MAOIs are used for depression, certain psychiatric or emotional conditions, or Parkinson's disease. This combination can be dangerous. Ask your pharmacist if you're unsure whether your medication is an MAOI.
  • Pre-existing conditions: Check with a doctor before use if you have heart disease, high blood pressure, thyroid disease, diabetes, trouble urinating due to an enlarged prostate gland, or liver or kidney disease.
  • Do not exceed the directed dose: Taking more than directed may cause drowsiness.
  • Stop and seek help if: An allergic reaction occurs (seek medical help right away); symptoms don't improve within 7 days or come with a fever; or you develop nervousness, dizziness, or sleeplessness.
  • Pregnancy and breastfeeding: Ask a health professional before use.
  • Keep out of reach of children.
🔀What it interacts with▾

The most important drug interaction to know about involves a specific class of medications:

  • MAOIs (monoamine oxidase inhibitors) — drugs used for depression, psychiatric or emotional conditions, or Parkinson's disease. Do not use this product while taking an MAOI or within 2 weeks of stopping one. The combination can be dangerous. Common MAOI drugs include phenelzine, tranylcypromine, selegiline, and others — ask your pharmacist if you're unsure.

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 have ever had an allergic reaction to this product or any of its ingredients
  • Do not use if you are currently taking a prescription MAOI or have taken one within the past 2 weeks
  • Ask a doctor before use if you have heart disease
  • Ask a doctor before use if you have thyroid disease
  • Ask a doctor before use if you have high blood pressure
  • Ask a doctor before use if you have diabetes
  • Ask a doctor before use if you have trouble urinating due to an enlarged prostate gland
  • Ask a doctor before use if you have liver or kidney disease — your doctor should determine if you need a different dose
  • Ask a health professional before use if you are pregnant or breastfeeding
  • Children under 12 years of age: ask a doctor before use
🚑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. Do not wait for symptoms to appear before calling.

📦How to store it▾

store between 20° C to 25° C (68° F to 77° F) • protect from light and store in a dry place

📄 Written from Loratadine / 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 Loratadine / Pseudoephedrine — the kind of thing our pharmacy team would talk through with you at the counter.

What exactly does this medicine do, and why does it have two ingredients? ▾
Great question. The two ingredients each do something different. Loratadine is an antihistamine — it targets the sneezing, runny nose, itchy eyes, and throat itching that come with hay fever or allergies. Pseudoephedrine is a decongestant — it helps shrink the swollen tissue inside your nasal passages so you can breathe more freely and relieve sinus pressure. Together, they cover both sides of your allergy or cold symptoms at once.
How do I take it, and does it matter if I crush or split the tablet? ▾
You take it by mouth with a full glass of water — but it's really important that you swallow it whole. Do not crush, split, chew, or dissolve it. These are extended-release tablets, meaning the medicine is designed to release slowly over time. Breaking the tablet damages that system and could release too much medicine too quickly. If swallowing the tablet whole is a challenge, talk to your pharmacist or doctor about your options.
How often do I take it — once a day or twice a day? ▾
That depends on which specific product you have. Some versions — like Alavert extended-release tablets — are taken every 12 hours, with no more than 2 tablets in a 24-hour period. Other products — like Allergy Relief-D — are once-daily, with no more than 1 tablet in 24 hours. Always check the label on your specific box, or ask your pharmacist if you're unsure which type you have.
Will this make me drowsy? I need to stay alert during the day. ▾
At the recommended dose, drowsiness is not listed as a typical effect — but taking more than directed can cause drowsiness. The bigger concern for alertness is actually the pseudoephedrine, which can sometimes cause nervousness, dizziness, or trouble sleeping in some people. If you notice any of those, stop taking it and check in with your doctor.
Are there any medications I absolutely cannot take this with? ▾
Yes — one important one. Do not use this product if you are taking a prescription MAOI (monoamine oxidase inhibitor), which is a type of medication used for depression, certain psychiatric conditions, or Parkinson's disease. You also need to wait at least 2 weeks after stopping an MAOI before taking this. If you're not sure whether any of your medications are MAOIs, ask your pharmacist before taking this — it's a quick check we're happy to do.
I have high blood pressure. Is it safe for me to take this? ▾
You should ask your doctor before taking this. The pseudoephedrine (decongestant) component can raise blood pressure, which is why people with heart disease, high blood pressure, thyroid disease, or diabetes are advised to check with their doctor first. The same goes if you have liver or kidney disease or trouble urinating due to an enlarged prostate. Your doctor can tell you whether it's appropriate for your specific situation.
Is Loratadine / Pseudoephedrine available over the counter? ▾
Yes — Loratadine / 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 Loratadine / Pseudoephedrine first available? ▾
Loratadine / Pseudoephedrine has been available in the United States since at least 2003, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Loratadine / Pseudoephedrine? ▾
Loratadine / Pseudoephedrine is supplied by 44 manufacturers listed in the FDA NDC Directory, including Strategic Sourcing Services LLC, Walgreen Company, Bayer HealthCare LLC..

💬 Answers drafted from Loratadine / 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 Loratadine / Pseudoephedrine comes

Loratadine / 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.

Extended-release tablet

By mouth
Brands Allergy And Congestion Relief Allergy And Nasal Congestion Allergy Relief-D Allergy Relief D Allergy Relief D 12 Careone Allergy And Congestion Relief Claritin-D Equate Allergy And Congestion Relief foster and thrive allergy D 12 hour Good Neighbor Pharmacy Loratadine D Kirkland Signature Allerclear D 12 Hr Kirkland Signature Allerclear D 24 Hr Perrigo Allergy D Topcare Allergy And Congestion Relief Wal-itin D
How this form is used
What it may be used for
  • Temporarily relieves sneezing, runny nose, itchy/watery eyes, and itching of the nose or throat due to hay fever or other upper respiratory allergies
  • Temporarily relieves nasal congestion due to the common cold, hay fever, or other upper respiratory allergies
  • Reduces swelling of the nasal passages and temporarily relieves sinus congestion and pressure
  • Temporarily restores freer breathing through the nose
Important instructions
  • Alavert: swallow tablet whole — do not divide, crush, chew, or dissolve; adults and children 12 and over take 1 tablet every 12 hours, no more than 2 tablets in 24 hours
  • Allergy Relief-D: swallow tablet whole — do not divide, crush, chew, or dissolve; adults and children 12 and over take 1 tablet daily with a full glass of water, no more than 1 tablet in 24 hours
  • allergy congestion relief: swallow tablet whole — do not divide, crush, chew, or dissolve; adults and children 12 and over take 1 tablet daily with a full glass of water, no more than 1 tablet in 24 hours
  • Children under 12 years of age and people with liver or kidney disease should ask a doctor before use
Available strengths 3 strengths
5 mg / 120 mg 10 mg / 240 mg 240 mg / 10 mg
100 FDA-listed product records ⓘ

📊 Loratadine / Pseudoephedrine across the U.S. market

How Loratadine / 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 ⓘ
44
Manufacturers
34
Brand names
100
FDA-listed product records ⓘ
2003
First marketed ⓘ
Strategic Sourcing Services LLC9%
Walgreen Company6%
Bayer HealthCare LLC.6%
L. Perrigo Company5%
Rite Aid Corporation5%
Remedyrepack Inc.4%
Other makers64%

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

📈 How widely Loratadine / Pseudoephedrine is used

A general measure of how commonly Loratadine / 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 Loratadine / 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.

84,649
Medicaid prescriptions filled (Q1–Q4 2025)
$2.1M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Loratadine / Pseudoephedrine prescribed? Of the 1,597 medications we measure, Loratadine / Pseudoephedrine ranks #532 by Medicaid prescriptions — more than 67% of them.

Where Loratadine / Pseudoephedrine ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #532 of 1,597
#527 Pimecrolimus Topical 90,935 Rx #528 Acamprosate 89,900 Rx #529 Bupivacaine / Epinephr... 89,693 Rx #530 Glyburide 89,361 Rx #531 Fluticasone / Vilanter... 85,370 Rx #532 Loratadine / Pseudoeph... 84,649 Rx #533 Gentamicin Ophthalmic 84,328 Rx #534 Ruxolitinib 84,308 Rx #535 Vibegron 84,266 Rx #536 Valbenazine 83,640 Rx #537 Colestipol 83,276 Rx

Utilization by Loratadine / 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.

The 10 mg / 240 mg 24 hr extended release oral tablet is the most-dispensed Loratadine / Pseudoephedrine product — about 77% of these Medicaid prescriptions.

24 HR loratadine 10 MG / pseudoephedrine sulfate 240 MG Extended Release Oral Tablet Most dispensed

65,083 Medicaid prescriptions (Q1–Q4 2025) 77% of Loratadine / Pseudoephedrine prescriptions shown $1.5M gross reimbursement (before rebates) ≈ $23 per prescription (gross)

Summed across the 12 of 96 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1117562

12 HR loratadine 5 MG / pseudoephedrine sulfate 120 MG Extended Release Oral Tablet

19,566 Medicaid prescriptions (Q1–Q4 2025) 23% of Loratadine / Pseudoephedrine prescriptions shown $621,603 gross reimbursement (before rebates) ≈ $32 per prescription (gross)

Summed across the 7 of 64 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1242399

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 Loratadine / 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 19 of 160 listed Loratadine / Pseudoephedrine NDCs with Medicaid activity.

🔍 Compare Loratadine / Pseudoephedrine products

A representative set of FDA-listed product records for Loratadine / 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 100 of 100 products — FDA National Drug Code Directory. See every product, package size and price: browse all 100 Loratadine / 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) Loratadine / Pseudoephedrine RxCUI 214682 2 dose forms · 3 strengths
  2. Dose form (SCDF) Oral Tablet RxCUI 393388 No current FDA listing
    Clinical drug / strength (SCD) loratadine 10 MG / pseudoephedrine sulfate 240 MG RxCUI 389113

Look up RxCUI 214682 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 Claritin-D allergy relief d 12 Allergy Relief-D Allergy and Congestion Relief perrigo allergy d foster and thrive allergy D 12 hour Kirkland Signature Allerclear D 24 Hr kirkland signature allerclear d 12 hr equate allergy and congestion relief good neighbor pharmacy loratadine d topcare allergy and congestion relief Wal-itin D allergy and nasal congestion careone allergy and congestion relief Claritin-D 12 Hour

🏭 Manufacturers & labelers

Strategic Sourcing Services LLC 9 Walgreen Company 6 Bayer HealthCare LLC. 6 L. Perrigo Company 5 Rite Aid Corporation 5 Remedyrepack Inc. 4 CVS Pharmacy 4 Ohm Laboratories Inc. 4 Amerisource Bergen 4 Costco Wholesale Company 3 Kroger Company 3 Heb 3 Sportpharm LLC 2 Kirkland-COSTCO WHOLESALE COMPANY 2 Patheon Manufacturing Services LLC 2 Publix Super Markets Inc 2 Wal-Mart Stores Inc 2 Padagis Israel Pharmaceuticals Ltd 2 Walgreens 2 Meijer Distribution, Inc. 2 Topco Associates LLC 2 Major Pharmaceuticals 2 The Kroger Company 2 Meijer Distribution Inc 2

…and 16 more on the FDA NDC directory.

RxNorm drug class

Loratadine / Pseudoephedrine belongs to the Other antihistamines for systemic use class.

Drug family (ATC) Other antihistamines for systemic use

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 Dec 5, 2025
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Loratadine / 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 Loratadine / Pseudoephedrine after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
50
NDC products indexed
100
Distinct labelers/manufacturers represented
44
Linked representative label ⓘ
Bayer HealthCare LLC.
Linked label effective
Dec 5, 2025
Composite sections available
7
Linked SPL Set ID
f046a807-ab8c-0620-e053-2a95a90a9d3c
Linked SPL Document ID
45370575-1a5d-c6f1-e063-6394a90a24c4
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 50 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. Bayer HealthCare 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.