FDA-filed SPL labeling · retrieved through openFDA

Levocetirizine

Levocetirizine is an antihistamine used to relieve symptoms of seasonal and perennial allergic rhinitis (hay fever) and to treat chronic idiopathic urticaria (long-lasting hives of unknown cause).

Brand names XyzalLevocetirizine Dihydrochlorideallergy reliefChildrens Xyzal AllergyXyzal Allergy 24HR +8 more
Drug class ⓘ Histamine-1 Receptor Antagonist
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 81 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 effectiveJul 22, 2025
Clinical labels in scope ⓘ81
AvailabilityRx/OTC
Earliest approval/marketing year ⓘ2007
FDA-listed product records ⓘ214
Boxed warningNone found in compared labels
How we combine label and product data →
✓No current FDA shortage listed · checked Sep 22, 2026
⭐ Levocetirizine at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Levocetirizine is an effective once-daily antihistamine for allergy symptoms and chronic hives, available in tablet and liquid forms for adults and children as young as 6 months (depending on the product). Its most notable side effect is drowsiness, so be cautious when driving or combining it with alcohol or sedatives. People with kidney disease need special guidance on dosing — always check with your pharmacist or doctor before starting.
How we write & review this content — our editorial policy →

📖 Levocetirizine: Patient Information Guide

A plain-language walkthrough of Levocetirizine — 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▾

Levocetirizine is an antihistamine used across several products to treat allergy symptoms and chronic hives. Supported uses include:

  • Seasonal allergic rhinitis (hay fever) — runny nose, sneezing, itchy/watery eyes, itchy nose or throat; approved for adults and children 6 years and older for most tablet forms, and 2 years and older for some coated tablet products.
  • Perennial allergic rhinitis (year-round allergies, often to dust mites or pet dander) — Levocetirizine Dihydrochloride oral solution and Xyzal oral solution are specifically indicated for children 6 months to 2 years of age for this use; tablet forms cover children 6 months and older (varies by product).
  • Chronic idiopathic urticaria (hives with no known cause) — indicated in adults and children as young as 6 months of age across oral solution and tablet formulations.
  • OTC tablet brands including 24HR Allergy Relief, Allergy Relief, Allergy Relief 24HR, Basic Care Allergy Relief, Curist Allergy Relief, and DG Health Allergy Relief temporarily relieve hay fever and respiratory allergy symptoms in adults and children 6 and older.
  • Children's Xyzal Allergy oral solution temporarily relieves hay fever and respiratory allergy symptoms in children 2 years and older (and adults).
⚙️How it works▾

Levocetirizine is an antihistamine — it works by selectively blocking H1 receptors, which are the specific sites on cells that the chemical histamine attaches to during an allergic response. By occupying those receptors, levocetirizine stops histamine from triggering the chain of reactions that causes sneezing, itching, runny nose, and hives. It is the active form (the pharmacologically active enantiomer) of cetirizine, and it binds to H1 receptors with about twice the affinity, though the clinical importance of that difference is not fully established.

💊How it's taken▾

Levocetirizine is taken by mouth, generally once daily in the evening. It can be taken with or without food — eating does not affect how much of the drug is absorbed overall, though a high-fat meal may slightly delay the peak effect. The scored tablets can be split in half when a lower dose is appropriate. Always follow the directions on your product's label, and do not exceed the recommended dose for your age group.

  • Tablets: once daily in the evening for adults and children 6 and older (dose varies by age — follow product labeling).
  • Oral solution: once daily in the evening for children 6 months and older (dose varies by age — follow product labeling).
  • Patients 12 and older with reduced kidney function may need a dose adjustment — ask your doctor or pharmacist.
🤒Side effects — in detail▾

Most people tolerate levocetirizine well, but side effects can occur. Common ones include:

  • Drowsiness or sleepiness — the most frequent side effect; dose-related
  • Fatigue or tiredness
  • Dry mouth
  • Nasopharyngitis (nasal congestion, runny nose, sore throat)
  • Pharyngitis (sore throat)
  • Fever — more common in young children
  • Cough and nosebleeds — reported in children 6–12
  • Diarrhea, vomiting, or ear infections — reported in children under 5

Seek medical attention if you experience difficulty urinating, signs of a severe allergic reaction (swelling, trouble breathing, widespread hives), or new intense itching that starts after you stop taking the medication.

⚠️Warnings & precautions▾
  • Drowsiness and impaired alertness: Levocetirizine can cause significant sleepiness and reduced coordination. Avoid driving, operating machinery, or doing hazardous tasks until you know how it affects you. Do not combine it with alcohol or other sedating medicines.
  • Urinary retention: Difficulty urinating has been reported. People with an enlarged prostate or a spinal cord condition should use this medication with extra caution. Stop taking it and contact your doctor if you have trouble urinating.
  • New itching after stopping: Some people — usually those who have taken levocetirizine for months or years — develop new, sometimes severe itching within a few days of stopping. If this happens, talk to your doctor; symptoms may improve by restarting or gradually reducing the dose.
  • Kidney impairment: This drug is mostly cleared by the kidneys. Lower kidney function means it stays in the body longer, raising the risk of side effects. Dose adjustment is needed for patients 12 and older with reduced kidney function.
🔀What it interacts with▾

Levocetirizine has a low risk of drug interactions through liver enzymes, but a few combinations still deserve caution:

  • Alcohol — adds to drowsiness and impairs alertness; avoid combining.
  • CNS depressants (sleep medications, sedatives, anti-anxiety drugs, certain pain medicines) — can increase sedation and mental impairment.
  • Theophylline (used for asthma or COPD) — may slightly slow the clearance of the closely related drug cetirizine; higher doses of theophylline could have a larger effect.
  • Ritonavir (HIV medication) — increased cetirizine exposure in studies; a similar interaction may occur with levocetirizine.

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 take if you are allergic to levocetirizine, cetirizine, or any ingredient in the product.
  • Do not take if you have end-stage kidney disease (very low kidney function) or are on hemodialysis.
  • Children 6 months to 11 years with any degree of kidney impairment should not take levocetirizine.
  • OTC tablet products should not be used in children under 6 years of age; Children's Xyzal Allergy oral solution should not be used in children under 2 years of age.
  • Adults 65 and older should ask a doctor before taking OTC products — aging reduces kidney function, which affects how this drug is cleared.
  • Tell your doctor if you have prostate enlargement or a spinal cord condition — urinary retention risk is higher.
  • Pregnancy: Human data are limited; animal studies showed no fetal harm at doses far above human doses. Discuss risks and benefits with your doctor.
  • Breastfeeding: No data exist on levocetirizine in human breast milk, but the related drug cetirizine has been found in animal milk. Talk to your doctor before using while breastfeeding.
  • Kidney disease requires dose adjustment for patients 12 and older — speak with your prescriber or pharmacist.
🚑If you take too much▾

Taking too much levocetirizine may cause drowsiness in adults; in children, agitation and restlessness may appear first, followed by drowsiness. There is no specific antidote. If an overdose is suspected, seek supportive medical care. Note that dialysis does not effectively remove this drug from the body.

📡Pharmacodynamics — effects in the body▾

Levocetirizine blocks the body's H1 histamine receptors, preventing histamine from triggering allergic symptoms like itching, swelling, and hives. Studies in adults and children showed that it suppressed the skin's wheal-and-flare response (the red, raised bump and surrounding redness caused by histamine injection) for at least 24 hours after a single dose. A high single dose of levocetirizine did not affect the heart's electrical activity (QT interval), and it is not expected to cause heart-rhythm effects based on its relationship to cetirizine.

🔬Pharmacokinetics — how your body processes it▾

Levocetirizine is absorbed quickly after an oral dose — peak blood levels from the tablet are reached in under an hour, and even faster from the oral solution (about 30 minutes). Food does not change the total amount absorbed, though a high-fat meal can slightly delay and reduce the peak level. The drug is about 91–92% bound to proteins in the blood and is minimally broken down by the liver (less than 14%). It is eliminated mainly through the kidneys — about 85% leaves the body in urine — with a half-life of roughly 8 to 9 hours in adults, meaning it takes about that long for the body to clear half the dose. Kidney impairment slows this clearance, which is why dose adjustments are needed for people with reduced kidney function.

📦How to store it▾

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) .

📄 Written from Levocetirizine’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 →

25

Supplements & herbs that interact with Levocetirizine

25 supplements and herbal products have documented interactions with Levocetirizine in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 1
  • Moderate · 15
  • Minor · 9
ACTIVATED CHARCOAL Major BEER Moderate BIOFEEDBACK Moderate COFFEE CHARCOAL Moderate DENDROBIUM Moderate EUROPEAN MANDRAKE Moderate GINKGO Moderate GLUCOMANNAN Moderate +17 more
Every supplement checked against Levocetirizine — ranked by severity The full interaction hub: 1 major · 15 moderate · 9 minor · every one linked to its full report. Check Levocetirizine against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

🩺 Pharmacist Counseling Corner

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

What exactly is levocetirizine used for? ▾
It's an antihistamine used to relieve the classic allergy symptoms — runny nose, sneezing, itchy and watery eyes, and itching of the nose or throat — caused by seasonal hay fever or year-round indoor allergies. It's also used to treat chronic idiopathic urticaria, which is hives that keep coming back for no clearly identified cause. Different products and formulations are approved for different age groups, so check your specific product's label.
Will this make me drowsy? ▾
It can, yes — drowsiness is the most commonly reported side effect and it's more likely at higher doses. Many people tolerate it fine, but until you know how it affects you, it's safest to avoid driving, operating heavy machinery, or anything else that needs your full attention. Alcohol and other sedating medicines like sleep aids will make the drowsiness worse, so try to avoid combining them.
Can I take this with food? ▾
Yes, you can take it with or without food — either way works. If you take it with a high-fat meal, it may take a little longer to kick in and the peak level in your blood may be slightly lower, but the total amount absorbed is the same. Taking it in the evening, as directed, means any drowsiness it causes happens while you're sleeping anyway.
What happens if I've been taking this a long time and then stop? ▾
Most people stop without any problems. However, a small number of people who have used levocetirizine for months or years have reported new, sometimes intense itching starting within a few days of stopping — even if they didn't have itching before they started it. If that happens to you, let your doctor know. Restarting or gradually tapering off often helps resolve it.
Is it safe for children, and are there any age limits? ▾
Yes, but the age requirements depend on the specific product and what it's being used for. The oral solution is approved for children as young as 6 months for certain uses. Tablet products are generally for children 6 years and older — children under 6 should not use OTC tablets. Always check the directions on the specific product you have to make sure it's appropriate for your child's age.
Do I need to be careful if I have kidney problems? ▾
Yes, definitely. Levocetirizine is cleared almost entirely by the kidneys, so if your kidneys aren't working at full capacity, the drug can build up in your body and the risk of side effects goes up. Patients 12 and older with reduced kidney function need a dose adjustment — ask your doctor or pharmacist what dose is right for you. The OTC labeling says not to use these products if you have kidney disease without checking with a doctor first. Dialysis doesn't remove this drug effectively, so standard hemodialysis isn't a solution if too much builds up.
Is Levocetirizine available over the counter? ▾
Both — Levocetirizine 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 Levocetirizine first available? ▾
Levocetirizine has been available in the United States since at least 2007, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Levocetirizine? ▾
Levocetirizine is supplied by 84 manufacturers listed in the FDA NDC Directory, including Bryant Ranch Prepack, Chattem, Inc., Proficient Rx LP.

💬 Answers drafted from Levocetirizine’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

📊Levocetirizine supplement interactions25 checked — ranked by severity 🌿Drug & Supplement CheckerLevocetirizine vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Levocetirizine NDCs & costs 🅰️Browse Drugs A–ZLook up any medication

💊 How Levocetirizine comes

Levocetirizine 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 24HR Allergy Relief Allergy Relief Allergy Relief 24HR Basic Care Allergy Relief Curist Allergy Relief DG Health Allergy Relief Goodmeds Levocetirizine Dihydrochloride 5mg 365 count Good Sense Levocetirizine Levocetirizine Dihydrochloride Topcare All Day Allergy Xyzal Xyzal Allergy 24HR
How this form is used
What it may be used for
  • These tablet products temporarily relieve runny nose, sneezing, itchy/watery eyes, and itching of the nose or throat due to hay fever or other respiratory allergies.
  • Allergy Relief 24HR, Allergy Relief, 24HR Allergy Relief, Basic Care Allergy Relief, Curist Allergy Relief, and DG Health Allergy Relief tablets are for adults and children 12 years of age and older (6–11 years at half-tablet dose).
Important instructions
  • Adults and children 12–64 years: take 1 tablet once daily in the evening; do not take more than 1 tablet in 24 hours. A half tablet once daily in the evening may be appropriate for less severe symptoms.
  • Children 6–11 years: take one-half tablet once daily in the evening; do not exceed one-half tablet in 24 hours.
  • Children under 6 years of age: do not use these tablet products.
  • Adults 65 and older and consumers with kidney disease: ask a doctor before use.
Available strengths 1 strength
5 mg
176 FDA-listed product records ⓘ

Oral solution

By mouth
Brands Childrens Xyzal Allergy Levocetirizine Dihydrochloride Xyzal
How this form is used
What it may be used for
  • Levocetirizine Dihydrochloride oral solution is indicated for perennial allergic rhinitis in children 6 months to 2 years of age.
  • Levocetirizine Dihydrochloride oral solution is indicated for chronic idiopathic urticaria in adults and children 6 months of age and older.
  • Xyzal oral solution is indicated for perennial allergic rhinitis in children 6 months to 2 years of age and for chronic idiopathic urticaria in adults and children 6 months of age and older.
  • Children's Xyzal Allergy oral solution temporarily relieves runny nose, sneezing, itchy/watery eyes, and itching of the nose or throat due to hay fever or other respiratory allergies.
Important instructions
  • Levocetirizine Dihydrochloride oral solution and Xyzal oral solution can be taken without regard to food.
  • Children's Xyzal Allergy: use only with the enclosed dosing cup; dose once daily in the evening.
  • Children's Xyzal Allergy: children 2–5 years take 2.5 mL once daily in the evening; children 6–11 years take 5 mL once daily in the evening; adults and children 12–64 may take 5 mL or 10 mL once daily in the evening depending on symptom severity.
  • Children's Xyzal Allergy: children under 2 years of age and consumers with kidney disease should not use this product without a doctor's guidance.
Available strengths 2 strengths
0.5 mg/mL 2.5 mg/5 mL
20 FDA-listed product records ⓘ

📊 Levocetirizine across the U.S. market

How Levocetirizine 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 ⓘ
84
Manufacturers
14
Brand names
214
FDA-listed product records ⓘ
2007
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.

Also listed with the FDA, not a patient dose form: Powder (18) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Bryant Ranch Prepack14%
Chattem, Inc.7%
Proficient Rx LP5%
A-S Medication Solutions4%
Dr. Reddy's Laboratories Inc.4%
Rite Aid Corporation4%
Other makers62%

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

📈 How widely Levocetirizine is used

A general measure of how commonly Levocetirizine 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 Levocetirizine 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.

1,014,061
Medicaid prescriptions filled (Q1–Q4 2025)
$11.8M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Levocetirizine prescribed? Of the 1,596 medications we measure, Levocetirizine ranks #175 by Medicaid prescriptions — more than 89% of them.

Where Levocetirizine ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #175 of 1,596
#170 Cariprazine 1,076,596 Rx #171 Naltrexone 1,052,053 Rx #172 Lurasidone 1,049,340 Rx #173 Ethinyl Estradiol / Fe... 1,023,509 Rx #174 Paliperidone 1,015,111 Rx #175 Levocetirizine 1,014,061 Rx #176 Clotrimazole Topical 1,007,055 Rx #177 Insulin Aspart (rDNA O... 1,003,363 Rx #178 Lisinopril and Hydroch... 999,534 Rx #179 Naloxone 980,072 Rx #180 Oxybutynin 974,653 Rx

Utilization by Levocetirizine 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 5 mg oral tablet is the most-dispensed Levocetirizine product — about 93% of these Medicaid prescriptions.

levocetirizine dihydrochloride 5 MG Oral Tablet Most dispensed

942,702 Medicaid prescriptions (Q1–Q4 2025) 93% of Levocetirizine prescriptions shown $9.6M gross reimbursement (before rebates) ≈ $10 per prescription (gross)

Summed across the 16 of 237 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 855172

levocetirizine dihydrochloride 0.5 MG/ML Oral Solution

71,359 Medicaid prescriptions (Q1–Q4 2025) 7% of Levocetirizine prescriptions shown $2.2M gross reimbursement (before rebates) ≈ $31 per prescription (gross)

Summed across the 2 of 18 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 855168

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 Levocetirizine, 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 18 of 255 listed Levocetirizine NDCs with Medicaid activity.

🔍 Compare Levocetirizine products

A representative set of FDA-listed product records for Levocetirizine — 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 200 of 214 products — FDA National Drug Code Directory. See every product, package size and price: browse all 214 Levocetirizine NDCs →

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Levocetirizine RxCUI 356887 2 dose forms · 2 strengths
  1. Dose form (SCDF) Oral Solution RxCUI 759919 In current FDA listings
    Clinical drug / strength (SCD) dihydrochloride 0.5 MG/ML RxCUI 855168
  2. Dose form (SCDF) Oral Tablet RxCUI 402343 In current FDA listings
    Clinical drug / strength (SCD) dihydrochloride 5 MG RxCUI 855172

Look up RxCUI 356887 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

Xyzal Levocetirizine Dihydrochloride allergy relief Childrens Xyzal Allergy Xyzal Allergy 24HR Curist Allergy Relief 24HR Allergy Relief Allergy Relief 24HR good sense levocetirizine basic care allergy relief DG Health Allergy Relief Goodmeds Levocetirizine Dihydrochloride 5mg 365 count Topcare All Day Allergy

🏭 Manufacturers & labelers

Bryant Ranch Prepack 23 Chattem, Inc. 12 Proficient Rx LP 8 A-S Medication Solutions 7 Dr. Reddy's Laboratories Inc. 7 Rite Aid Corporation 6 PD-Rx Pharmaceuticals, Inc. 6 NuCare Pharmaceuticals,Inc. 5 Preferred Pharmaceuticals, Inc. 5 Walgreens Company 5 Camber Pharmaceuticals, Inc. 4 Little Pharma, Inc. 4 Remedyrepack Inc. 4 Micro Labs Limited 4 L. Perrigo Company 3 Kroger Company 3 Heb 3 Glenmark Pharmaceuticals Inc., USA 3 Walgreen Company 3 Target Corporation 3 Albertsons Companies 3 Cvs Pharmacy 3 Yyba Corp 3 Amerisourcebergen Drug Corporation 3

…and 16 more on the FDA NDC directory.

RxNorm drug class

Levocetirizine belongs to the Histamine-1 Receptor Antagonist class.

Pharmacologic class Histamine-1 Receptor Antagonist
Drug family (ATC) Piperazine derivatives
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 Jul 22, 2025
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Levocetirizine.
📈
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 Levocetirizine after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
81
NDC products indexed
214
Distinct labelers/manufacturers represented
84
Linked representative label ⓘ
Chattem, Inc.
Linked label effective
Jul 22, 2025
Composite sections available
23
Linked SPL Set ID
1673f7ff-0c7c-4403-86cf-c05eb1475222
Linked SPL Document ID
87a83f00-5abf-437d-af13-394c22964050
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 81 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.