FDA-filed SPL labeling · retrieved through openFDA

Fexofenadine and Pseudoephedrine

Fexofenadine and 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 Allegra-dFexofenadine HCl and Pseudoephedrine HCIAllegra-D Allergy and CongestionAllergy and Congestion12HR Allergy and Congestion Relief +4 more
Drug classes ⓘ Adrenergic Alpha-agonists
OTC Form 1 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 43 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 effectiveJan 12, 2026
Clinical labels in scope ⓘ43
AvailabilityOTC
Earliest approval/marketing year ⓘ2011
FDA-listed product records ⓘ90
Boxed warningNone found in compared labels
How we combine label and product data →
✓No current FDA shortage listed · checked Sep 28, 2026
⭐ Fexofenadine and Pseudoephedrine at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Fexofenadine and pseudoephedrine extended-release tablets combine an antihistamine and a decongestant to tackle allergy symptoms and nasal congestion at the same time. Take on an empty stomach, swallow whole, and stick to the dosing schedule on your specific product's label. If you have heart disease, high blood pressure, kidney disease, or take an MAOI, talk to your doctor or pharmacist before using this medication.
How we write & review this content — our editorial policy →

📖 Fexofenadine and Pseudoephedrine: Patient Information Guide

A plain-language walkthrough of Fexofenadine and 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▾

Fexofenadine and pseudoephedrine extended-release tablets are used to relieve allergy and congestion symptoms. All supported products share the following uses:

  • 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
  • Temporarily relieves nasal congestion caused by the common cold, hay fever, or other upper respiratory allergies
  • Reduces swelling of 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 on an empty stomach with a full glass of water. The tablet must be swallowed whole — never divided, crushed, chewed, or dissolved.

  • Allegra-D Allergy and Congestion (24-hour products): 1 tablet every 24 hours; no more than 1 tablet per day
  • 12-hour products (such as Equate Allergy Relief D and 12HR Allergy and Congestion Relief): 1 tablet every 12 hours; no more than 2 tablets per day

Children under 12 should not use this medication. Adults 65 and older and anyone with kidney disease should check with a doctor before use. Always follow the directions on your specific product's label.

🤒Side effects — in detail▾

Side effects reported with this medication include:

  • Nervousness
  • Dizziness
  • Trouble sleeping
  • Tablet coating visible in stool (this is normal and not a cause for concern)

Stop taking this medication and get medical help right away if you have signs of an allergic reaction. Contact your doctor if you feel very nervous, dizzy, or sleepless, or if your symptoms don't improve within 7 days or come with a fever.

⚠️Warnings & precautions▾
  • MAOI interaction: Do not use this product if you are taking or have taken a prescription MAOI drug within the past 2 weeks. This includes certain medications for depression, psychiatric conditions, emotional conditions, or Parkinson's disease. Ask your pharmacist if you are unsure whether your medication is an MAOI.
  • Do not use if you have ever had an allergic reaction to this product or any of its ingredients, or if you have difficulty swallowing.
  • Talk to your doctor first if you have heart disease, high blood pressure, thyroid disease, glaucoma, diabetes, an enlarged prostate, or kidney disease.
  • Pregnant or breastfeeding? Ask a health professional before using this product.
  • Do not give to children under 12 years of age.
  • In case of overdose, contact a Poison Control Center right away at 1-800-222-1222.
🔀What it interacts with▾

This medication can interact with certain drugs and foods — here's what to watch for:

  • MAOI drugs (used for depression, psychiatric conditions, or Parkinson's disease): do not use together or within 2 weeks of stopping an MAOI — this combination can be dangerous
  • Aluminum or magnesium antacids (common heartburn/indigestion remedies): do not take at the same time as this medication
  • Fruit juices: do not take this medication with fruit juices; use water instead

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 fexofenadine, pseudoephedrine, or any ingredient in this product
  • Do not use if you have difficulty swallowing tablets
  • Do not use if you are taking a prescription MAOI or have taken one in the past 2 weeks
  • Ask a doctor before use if you have heart disease, thyroid disease, glaucoma, high blood pressure, or 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 kidney disease — your doctor may need to determine the right dose for you
  • Adults 65 years and older should ask a doctor before use
  • Do not give to children under 12 years of age
  • If you are pregnant or breastfeeding, ask a health professional 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. Keep this product out of reach of children.

📦How to store it▾

store between 20° to 25°C (68° to 77°F) USP dissolution test is pending.

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

What exactly does this medication do — does it just help with allergies? ▾
It actually tackles two things at once. The fexofenadine part is an antihistamine that helps with allergy symptoms like runny nose, sneezing, itchy and watery eyes, and itching of the nose or throat. The pseudoephedrine part is a nasal decongestant that reduces swelling in your nasal passages and relieves sinus congestion and pressure. It also helps with nasal congestion from a common cold, not just allergies.
Does it matter when I take it — like with food or on an empty stomach? ▾
Yes, it really does matter. You should take this tablet on an empty stomach with a full glass of water. Also, use water specifically — do not take it with fruit juice. Taking it with food or juice may affect how well it works.
Can I cut or crush the tablet to make it easier to swallow? ▾
No — you need to swallow it whole. These are extended-release tablets, which means the medication is designed to release slowly over time. Crushing, chewing, splitting, or dissolving the tablet would break that release system and could affect how the medication works. If swallowing tablets is a real challenge for you, let your pharmacist know before starting this medication.
I noticed part of the tablet came out in my stool. Is something wrong? ▾
That's completely normal and nothing to worry about. With extended-release tablets, the outer coating can sometimes pass through your digestive system intact and show up in the stool. The medication itself has already been absorbed by your body. Keep taking it as directed.
Are there any medications or foods I should definitely avoid while taking this? ▾
Yes — a few important ones. Don't take this product if you're using a prescription MAOI drug (used for depression, Parkinson's disease, or certain other conditions) or have taken one within the past 2 weeks. Don't take it at the same time as aluminum or magnesium antacids. And avoid taking it with fruit juice — stick to water. If you're not sure whether any of your current medications could interact, your pharmacist can quickly check for you.
I have high blood pressure — is it safe for me to take this? ▾
You should ask your doctor before using this one. Pseudoephedrine, the decongestant in this medication, is something people with heart disease, high blood pressure, thyroid disease, diabetes, or glaucoma need to be cautious about. Your doctor can help decide if it's appropriate for you and whether any dose adjustments are needed — especially if you also have kidney disease.
Is Fexofenadine and Pseudoephedrine available over the counter? ▾
Yes — Fexofenadine and 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 Fexofenadine and Pseudoephedrine first available? ▾
Fexofenadine and Pseudoephedrine has been available in the United States since at least 2011, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Fexofenadine and Pseudoephedrine? ▾
Fexofenadine and Pseudoephedrine is supplied by 34 manufacturers listed in the FDA NDC Directory, including Walgreens company, Rugby Laboratories, Rite Aid Corporation.

💬 Answers drafted from Fexofenadine and 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 CheckerFexofenadine and Pseudoephedrine vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Fexofenadine and Pseudoephedrine NDCs & costs 🅰️Browse Drugs A–ZLook up any medication

💊 How Fexofenadine and Pseudoephedrine comes

Fexofenadine and 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 12HR Allergy and Congestion Relief Allegra-d Allegra-D Allergy and Congestion Allergy and Congestion Equate Allergy Relief D Fexofenadine HCl and Pseudoephedrine HCI Foster And Thrive Allergy And Congestion D Leader 12hr Allergy And Congestion Relief Rugby Allergy Relief D
How this form is used
What it may be used for
  • Temporarily relieves runny nose, sneezing, 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 nasal passages and temporarily relieves sinus congestion and pressure
  • Temporarily restores freer breathing through the nose
Important instructions
  • Allegra-D Allergy and Congestion (24-hour product): take 1 tablet with a glass of water every 24 hours on an empty stomach; do not take more than 1 tablet in 24 hours
  • Equate Allergy Relief D and 12HR Allergy and Congestion Relief products: take 1 tablet with a glass of water every 12 hours on an empty stomach; do not take more than 2 tablets in 24 hours
  • Swallow the tablet whole — do not divide, crush, chew, or dissolve it
  • Children under 12 years of age should not use; adults 65 and older and those with kidney disease should ask a doctor before use
Available strengths 2 strengths
60 mg / 120 mg 180 mg / 240 mg
90 FDA-listed product records ⓘ

📊 Fexofenadine and Pseudoephedrine across the U.S. market

How Fexofenadine and 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 ⓘ
34
Manufacturers
11
Brand names
90
FDA-listed product records ⓘ
2011
First marketed ⓘ
Walgreens company7%
Rugby Laboratories6%
Rite Aid Corporation6%
CVS Pharmacy6%
Kroger Company4%
Cardinal Health4%
Other makers68%

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

📈 How widely Fexofenadine and Pseudoephedrine is used

A general measure of how commonly Fexofenadine and 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 Fexofenadine and 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.

139
Medicaid prescriptions filled (Q1–Q4 2025)
$2,390 gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Fexofenadine and Pseudoephedrine prescribed? Of the 1,597 medications we measure, Fexofenadine and Pseudoephedrine ranks #1,475 by Medicaid prescriptions — more than 8% of them.

Where Fexofenadine and Pseudoephedrine ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #1,475 of 1,597
#1,470 Hyaluronidase-Nvhy / N... 145 Rx #1,471 Brigatinib 144 Rx #1,472 Rezafungin Injection 144 Rx #1,473 Pirtobrutinib 143 Rx #1,474 Meropenem and Vaborbac... 140 Rx #1,475 Fexofenadine and Pseud... 139 Rx #1,476 Bexarotene Topical 137 Rx #1,477 Nelarabine Injection 136 Rx #1,478 Ibalizumab-uiyk Inject... 136 Rx #1,479 Crizotinib 130 Rx #1,480 Efavirenz, Lamivudine,... 128 Rx

Utilization by Fexofenadine and 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 fexofenadine hydrochloride 60 MG / pseudoephedrine hydrochloride 120 MG Extended Release Oral Tablet

139 Medicaid prescriptions (Q1–Q4 2025) 100% of Fexofenadine and Pseudoephedrine prescriptions shown $2,390 gross reimbursement (before rebates) ≈ $17 per prescription (gross)

Summed across the 2 of 92 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 997406

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 Fexofenadine and 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 2 of 92 listed Fexofenadine and Pseudoephedrine NDCs with Medicaid activity.

🔍 Compare Fexofenadine and Pseudoephedrine products

A representative set of FDA-listed product records for Fexofenadine and 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 90 of 90 products — FDA National Drug Code Directory. See every product, package size and price: browse all 90 Fexofenadine and Pseudoephedrine NDCs →

🏷️ Sold under these brand names

Allegra-d Fexofenadine HCl and Pseudoephedrine HCI Allegra-D Allergy and Congestion Allergy and Congestion 12HR Allergy and Congestion Relief Foster And Thrive Allergy And Congestion D Rugby Allergy Relief D Leader 12hr Allergy And Congestion Relief Equate Allergy Relief D

🏭 Manufacturers & labelers

Walgreens company 6 Rugby Laboratories 5 Rite Aid Corporation 5 CVS Pharmacy 5 Kroger Company 4 Cardinal Health 4 Strategic Sourcing Services, LLC 4 Chattem, Inc. 4 Walgreen Co. 3 Wal-mart Stores, Inc. 3 Aurohealth LLC 3 Ohm Laboratories Inc. 3 CVS Health Corp 3 AmeriSource Bergen 3 Dr.Reddy's Laboratories Inc 3 Sun Pharmaceutical Industries, Inc. 3 Dr. Reddy's Laboratories Inc. 3 Wal-mart Stores Inc. 2 A-S Medication Solutions 2 CVS Pharmacy, Inc. 2 Dr. Reddy's Laboratories Limited 2 Publix Super Markets, Inc 2 Walmart Inc. 2 The Kroger Co. 2

…and 10 more on the FDA NDC directory.

RxNorm drug class

Fexofenadine and Pseudoephedrine belongs to the Histamine-1 Receptor Antagonist class.

Pharmacologic class Histamine-1 Receptor Antagonist
Drug family (ATC) Other antihistamines for systemic use
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 Jan 12, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Fexofenadine and 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 Fexofenadine and Pseudoephedrine after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
43
NDC products indexed
90
Distinct labelers/manufacturers represented
34
Linked representative label ⓘ
Chattem, Inc.
Linked label effective
Jan 12, 2026
Composite sections available
7
Linked SPL Set ID
1fb77d6a-fae2-40ae-8f8e-fa2dc66f4403
Linked SPL Document ID
de126d31-d1bb-490f-bf3f-fd9faf4f20ab
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 43 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. Chattem, Inc. 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.