What this pack is
XYZAL is the brand name in this record; levocetirizine dihydrochloride tablets and oral solution is the generic name. Read both together with the dosage form (multiple oral forms (tablets and oral liquid)).
PACK CHECK · MARKET FIRST
XYZALGeneric namelevocetirizine dihydrochloride tablets and oral solution
How this medicine works
The label describes levocetirizine as an oral H1-receptor antagonist and the R-enantiomer of cetirizine. This explains an allergy pathway; it neither proves symptoms are allergic nor creates milligram conversion, combination or rotation rules with cetirizine, loratadine, fexofenadine or diphenhydramine.
Read source: United States ↗Current regulatory record · reviewed 2026-09-03More about its action and precautions →Check the market, names, dosage form and route together
A medicine may use different brand names across markets. Keep the market, brand, generic name, dosage form and route together; one matching field does not prove that two packs are the same or interchangeable.
Open the complete product-identity record
Use these fields when the pack, market name or package image needs closer checking. They are evidence boundaries, not substitution instructions.
- International brand name
- XYZAL
- Source-scoped market brand names
- XYZAL · U.S. prescription productCurrent regulator record ↗NDA 022064/022157; 5 mg tablets and 0.5 mg/mL oral solution.
- XYZAL ALLERGY 24HR · U.S. nonprescription productCurrent regulator record ↗NDA 209089; 5 mg immediate-release oral tablets in distinct packs.
The evidence status and note below apply only to the stated market and source. They do not prove that packs in different markets can be substituted.
- Generic name
- levocetirizine dihydrochloride tablets and oral solution
- Dosage-form class
- Immediate-release oral tablets and oral solution. Five mg is the amount per tablet; 2.5 mg/5 mL and 0.5 mg/mL are two expressions of the same oral-solution concentration. Tablet strength, liquid concentration and bottle/blister counts must not be added or converted into an individual tablet or millilitre amount.
- Route
- Oral
- Package-image status
- A source-linked public label image is available below
No source-verifiable mainland-China trade-name cue has been established for this record. This does not establish whether the medicine exists, is approved or is available in mainland China. Check pack text and current CDE/NMPA records item by item.
FOR EVERYDAY QUESTIONS
After the leaflet, continue with the question you still need to check
What this page can show
This is a source-traceable public record. It helps you read the product identity and its listed source documents; each market still needs its own current record check.
What to bring to the next conversation
Bring the actual pack, the label or prescription, and a complete medicine list when you speak with a pharmacist or clinician.
NEXT SAFE STEP
Choose the next safe check
A question about changing, combining or splitting?Put the exact packs on one list before a pharmacist or prescriber checks the full context.Open the family medicine list →A question about cost, reimbursement or availability?First lock the market, exact presentation and date. Use local official reimbursement, hospital or pharmacy channels for a current answer rather than a web estimate.Open regulator and market-record entry points →Unsure about a pack or a cross-border product?Photo reading can return possible record matches only. Check the actual product against the current regulator record for its market.Identify pack text locally →Saw a recall, approval or procurement headline?Open the original publisher, then match its product, market and date. Do not make a stop or switch decision from a headline.Read primary-source news →
PRODUCT PRESENTATION IDENTITY
Strength, pack and device identity
Package strength is not an individual dose. These fields help identify the exact labelled product; they do not calculate how much, how often, a missed-use action, splitting, switching or conversion.
How to read a score line: ‘scored’ or ‘unscored’ first identifies this labelled presentation. A score line by itself does not permit self-splitting, reducing or changing the product. Only an explicit statement in the current label for this exact presentation, checked with a pharmacist against the prescription, can support any further handling.
5 source-backed strength, pack or device records — open the full list
First match the market, dosage form and labelled amount on the pack in hand. The number of tablets, sachets or devices in a pack is not a personal dose or schedule.
United States label · Current U.S. prescription brand label (revised Jul 2025)
Levocetirizine dihydrochloride 5 mg per tablet; 90-tablet bottle
- Product code
- NDC 0024-5803-90
- Form and route
- XYZAL prescription immediate-release film-coated tablet · oral
- Container
- bottle
- Listing review
- Current label display and NDC Directory listing reviewed 2026-09-03; actual marketing, stock and availability are not established.
- levocetirizine dihydrochloride
- 5 mglabelled amount per tablet; not a universal tablet count, frequency, stopping or restart plan
- Package
- 90 tablets per pack
- Labelled appearance
- white · oval scored tablet; the score is an exact-product clue, not universal permission to self-split · imprint Y / Y (red)Scored in this exact label; this does not transfer to another product or permit self-splitting
United States label · Current U.S. prescription brand label (revised Jul 2025)
Levocetirizine dihydrochloride 2.5 mg per 5 mL (0.5 mg/mL); 5 fl oz bottle
- Product code
- NDC 0024-5804-05
- Form and route
- XYZAL prescription oral solution · oral
- Container
- polypropylene bottle
- Listing review
- Current label display and NDC Directory listing reviewed 2026-09-03; actual marketing, stock and availability are not established.
- levocetirizine dihydrochloride
- 2.5 mglabelled amount per 5 mL; 0.5 mg/mL is a concentration, not an individual measuring plan
- Package
- 5 fl oz per bottle
- Labelled appearance
- colourless solution · oral liquid; an appropriate measuring device is required · imprint not applicable
United States label · Current U.S. OTC Drug Facts (Mar 2026)
Levocetirizine dihydrochloride 5 mg per tablet; 10-tablet blister pack
- Product code
- NDC 41167-3510-0
- Form and route
- XYZAL ALLERGY 24HR nonprescription immediate-release tablet · oral
- Container
- blister pack
- Listing review
- Current label display and NDC Directory listing reviewed 2026-09-03; actual marketing, stock and availability are not established.
- levocetirizine dihydrochloride
- 5 mglabelled amount per tablet; not a universal tablet count, frequency, stopping or restart plan
- Package
- 10 tablets per pack
- Labelled appearance
- white · oval scored tablet; the score is an exact-product clue, not universal permission to self-split · imprint X / XScored in this exact label; this does not transfer to another product or permit self-splitting
United States label · Current U.S. OTC Drug Facts (Mar 2026)
Levocetirizine dihydrochloride 5 mg per tablet; 35-tablet bottle
- Product code
- NDC 41167-3510-1
- Form and route
- XYZAL ALLERGY 24HR nonprescription immediate-release tablet · oral
- Container
- bottle
- Listing review
- Current label display and NDC Directory listing reviewed 2026-09-03; actual marketing, stock and availability are not established.
- levocetirizine dihydrochloride
- 5 mglabelled amount per tablet; not a universal tablet count, frequency, stopping or restart plan
- Package
- 35 tablets per pack
- Labelled appearance
- white · oval scored tablet; the score is an exact-product clue, not universal permission to self-split · imprint X / XScored in this exact label; this does not transfer to another product or permit self-splitting
United States label · Current U.S. OTC Drug Facts (Mar 2026)
Levocetirizine dihydrochloride 5 mg per tablet; 20-tablet blister pack
- Product code
- NDC 41167-3511-2
- Form and route
- XYZAL ALLERGY 24HR nonprescription immediate-release tablet · oral
- Container
- blister pack
- Listing review
- Current label display and NDC Directory listing reviewed 2026-09-03; actual marketing, stock and availability are not established.
- levocetirizine dihydrochloride
- 5 mglabelled amount per tablet; not a universal tablet count, frequency, stopping or restart plan
- Package
- 20 tablets per pack
- Labelled appearance
- white · oval scored tablet; the score is an exact-product clue, not universal permission to self-split · imprint X / XScored in this exact label; this does not transfer to another product or permit self-splitting
PUBLIC LABEL IMAGE
Appearance and package-text clues
This current public-label package panel helps check the brand, generic name, strength and dosage-form clues only. It does not authenticate a product in hand or establish originator status, availability, sale eligibility, another package or another market.
Open the public label source ↗LABEL READING · NOT A PRESCRIPTION
XYZAL enlarged label: mg per tablet, liquid concentration, drowsiness, kidney function and itching after stopping
Reading level: drug-specific label reading. This record has been expanded around its dosage form or a higher-risk reading question; the current target-market label and professional review still apply.
Prescription and OTC XYZAL do not share one interchangeable instruction set. Five mg is the amount per tablet; 2.5 mg/5 mL equals 0.5 mg/mL and describes the oral-solution concentration. The site clarifies product and safety questions but does not calculate an individual's tablets, millilitres, splitting, stopping or restart plan.
- U.S. OTC Drug Facts separately flags age 65 or older, kidney disease, and prior trouble urinating or emptying the bladder for professional review or non-use; the prescription label also emphasizes renal excretion and urinary-retention risk. An OTC status does not make the product suitable for every older adult.
- Drowsiness, fatigue and reduced alertness can affect driving, machinery and falls; alcohol, sleep medicines, sedatives and other CNS depressants may further reduce alertness. Do not assume self-spacing removes the risk; list every prescription, OTC cold/allergy product and alcohol use for a pharmacist or clinician.
- FDA's 2025 communication says rare but potentially severe widespread itching may begin within days after stopping long-term daily use. This is not a self-directed abrupt-stop, restart or taper guide. Discuss planned long-term use, and contact a local professional if severe itching appears after stopping.
- The prescription tablet is scored and the OTC label contains half-tablet wording for defined U.S. label populations, but this belongs only to those exact products and populations. A score does not give universal permission to split any levocetirizine product in any market, and oral-solution concentration must not be converted directly into a tablet count.
PHARMACOVIGILANCE · OFFICIAL ROUTES
Check safety information in the right market
Start with the public label or product record linked to this dossier, then use the official safety routes below for the market that applies to the medicine in hand.
Match five details before using a safety record
- Brand and generic nameBoth must match the medicine named by the record.
- Dosage form and strengthTablet, capsule, injection, inhaler, patch and eye drop are not interchangeable.
- Market and notice dateA record applies only to the country or region and date it names.
- Lot, pack and manufacturerRecord these only when the official notice specifically names them.
- Current product informationA historical record may have been superseded by the current label.
This checklist only helps organise the right question. It does not create a personal conclusion about stopping, switching, dose, combination or suitability.
This dossier’s product-level source checkU.S. National Library of Medicine DailyMed · United States · Public medicine label · 2026-09-03
This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk.
Markets actually represented by the reviewed product documents
- United States · 2
This is a document-coverage summary, not a claim that the medicine is authorised, supplied, interchangeable or actively monitored in every listed market today.
This record’s label or product-record routeDailyMed (NLM): current U.S. prescription XYZAL levocetirizine label (revised Jul 2025) ↗Current regulatory record · reviewed 2026-09-03
Other official market or version documents for this record
These are separately reviewed product documents for the same dossier. Their market, date, dosage form and document status must stay attached to each link; they do not establish interchangeability between products, strengths, packs, indications or countries.
- U.S. National Library of Medicine DailyMed · United States · Public medicine label · 2026-09-03DailyMed (NLM): current U.S. OTC Drug Facts and package panels for XYZAL ALLERGY 24HR levocetirizine (SPL v14, Mar 2026) ↗Current regulatory record · reviewed 2026-09-03
Reviewed official safety records
A dated record is not automatically a current alert. Read the named product, form, batch, market, date and source type before treating it as relevant.
- FDA Drug Safety Communication: rare but severe itching after stopping long-term oral levocetirizine/XYZAL2025-05-16 · On 16 May 2025, FDA said rare but potentially severe itching can occur after stopping long-term regular use of oral levocetirizine or cetirizine; the communication covers U.S. prescription and nonprescription products and requires label updates. This regulator record cannot predict an individual event or provide a self-directed stop, restart, taper, switch or antihistamine-combination plan. Discuss planned long-term use, and contact a local pharmacist, prescriber or medical service with the actual pack and complete medicine list if severe itching appears after stopping.Primary-source record (open linked document) ↗reviewed 2026-09-03
Global official safety gateways
- NMPA Centre for Drug Reevaluation · Mainland ChinaPrimary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item.Drug-vigilance bulletins and safety notices ↗reviewed 2026-08-22
- FDA · United StatesPrimary FDA pages for important new safety issues, labelling changes and risk communications.Drug Safety Communications ↗reviewed 2026-08-22
- FDA MedWatch · United StatesU.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality.Safety information and serious-problem reporting ↗reviewed 2026-08-22
- EMA · European Union / European Economic AreaOfficial EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment.Pharmacovigilance overview and EudraVigilance ↗reviewed 2026-08-22
- MHRA · United KingdomPrimary UK MHRA medicine-safety updates for professionals and the public.Drug Safety Update ↗reviewed 2026-08-22
- PMDA · JapanPMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents.Medicine safety information ↗reviewed 2026-08-22
- MFDS · Republic of KoreaMFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case.Medicine safety letters ↗reviewed 2026-08-22
- HSA · SingaporeHSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information.Adverse-event reporting and medicine-safety information ↗reviewed 2026-08-22
- Health Canada · CanadaHealth Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item.MedEffect Canada: advisories, warnings and recalls ↗reviewed 2026-08-22
- TGA · AustraliaPrimary Australian TGA safety alerts, advisories and monitoring information for therapeutic products.Medicine safety alerts ↗reviewed 2026-08-22
- Swissmedic · SwitzerlandOfficial Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality.Pharmacovigilance and suspected adverse-reaction reporting ↗reviewed 2026-08-22
- Medsafe · New ZealandNew Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information.Medicine safety communications ↗reviewed 2026-08-22
- SAHPRA · South AfricaSAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information.Medicine safety information, alerts and pharmacovigilance ↗reviewed 2026-08-22
- WHO · GlobalWHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market.Medicine and vaccine safety-alert archive ↗reviewed 2026-08-22
- Anvisa · BrazilAnvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item.Pharmacovigilance, alerts and VigiMed ↗reviewed 2026-08-22
This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline.
For severe or rapidly worsening symptoms, suspected overdose, a severe allergic reaction, loss of consciousness or another emergency, use local emergency services. Do not wait for an online alert search or change a medicine from this page.
PRIVATE FAMILY LIST
Bring this record into a local medicine list
Only the brand, generic name, dosage form and route are added, and they stay in this browser. Copy strength, label directions, start/stop history and any concern from the actual pack; this tool does not calculate a dose or decide combination, switching or stopping.
Add to the family medicine list →PACK · LABEL · MEDICINE LIST
Six checks for this medicine pack
Use this card to organise questions about XYZAL (levocetirizine dihydrochloride tablets and oral solution). Keep the exact pack, its current label and the full medicine list together.
Identify the exact product
XYZAL is the brand in this record and levocetirizine dihydrochloride tablets and oral solution is the active-ingredient name. Check both with the dosage form (Immediate-release oral tablets and oral solution. Five mg is the amount per tablet; 2.5 mg/5 mL and 0.5 mg/mL are two expressions of the same oral-solution concentration. Tablet strength, liquid concentration and bottle/blister counts must not be added or converted into an individual tablet or millilitre amount.) and the market on the actual pack.
Read the labelled strength in context
mg, mcg, mg/mL or a percentage describes the labelled amount in one tablet, capsule, measured volume, spray or other unit. It is not an answer to how many units a person should take.
Check before splitting or opening
Before splitting, crushing, chewing or opening anything, find an explicit instruction for this exact product in its current label and ask a pharmacist. A score line or a previous pack is not enough by itself.
Put every product on one list
Include prescriptions, over-the-counter products, eye drops, creams, vitamins, minerals, herbs and supplements. A pharmacist or prescriber needs the whole list before any combination, alternation, switch or stop is considered.
Ask a specific pharmacogenetics question
Ask which medicine, which gene and what clinical decision a result could change. A gene–drug association does not mean broad genetic testing is needed for everyone and must not be used to change treatment without professional review.
Know when to seek urgent help
For a suspected overdose, a severe allergic reaction, fainting or difficulty breathing, use the local emergency or poison-information service now. Do not wait for a website reply or alter several medicines to test what caused it.
This card does not calculate a dose, decide whether medicines can be combined, or replace a clinician or pharmacist. Market-specific current labels and the person's full context still need review.
MARKET DOCUMENTS · READ SEPARATELY
Enlarged market leaflets and regulator documents
Each link retains its own market, date, dosage form and document status. These documents support larger-print reading and item-by-item checking; they do not make products, strengths, packs, indications or use between countries or regions interchangeable.
- DailyMed (NLM): current U.S. prescription XYZAL levocetirizine label (revised Jul 2025) ↗Current regulatory record · reviewed 2026-09-03
- DailyMed (NLM): current U.S. OTC Drug Facts and package panels for XYZAL ALLERGY 24HR levocetirizine (SPL v14, Mar 2026) ↗Current regulatory record · reviewed 2026-09-03
HOW IT WORKS · NOT A TREATMENT PLAN
How levocetirizine works: peripheral H1-receptor blockade does not make antihistamines interchangeable
- ‘Second generation’ or ‘less sedating’ does not mean no drowsiness. Individual response, age, kidney function, alcohol and other sedatives need review together.
- XYZAL and ZYRTEC are related in chemistry but are not the same exact product. A shared mechanism does not permit co-use, alternate-day rotation, milligram exchange or make-up use with one another.
- Congestion, rash, itching or a runny nose can have other causes. Trouble breathing, swelling of the face/lips/tongue/throat, altered awareness or another severe symptom requires local emergency help rather than continued website comparison of allergy medicines.
SOURCE EVIDENCE REGISTER
Source evidence map
Every public link is labelled with its market, document status and document type. A historical public record is not a current label, and an official lookup entry is not a product-specific record.
- DailyMed (NLM): current U.S. prescription XYZAL levocetirizine label (revised Jul 2025) ↗Current regulatory record · reviewed 2026-09-03
- DailyMed (NLM): current U.S. OTC Drug Facts and package panels for XYZAL ALLERGY 24HR levocetirizine (SPL v14, Mar 2026) ↗Current regulatory record · reviewed 2026-09-03
- FDA: 16 May 2025 drug safety communication on rare but potentially severe itching after stopping long-term oral cetirizine or levocetirizine ↗reviewed 2026-09-03
- FDA: XYZAL ALLERGY 24HR NDA 209089/209090 OTC-switch review materials (2017) ↗reviewed 2026-09-03
SOURCE-TRACEABLE ARCHIVE
XYZALlevocetirizine dihydrochloride tablets and oral solution
This page includes an exact current U.S. public-label package panel for XYZAL, alongside documentary primary-source material. It helps check product identity, but does not itself establish originator status, product quality, availability or sale eligibility.
DOCUMENT TIMELINE
Document timeline
U.S. approval of prescription XYZAL tablets
FDA pediatric review links NDA 022064 to the 2007 approval of levocetirizine tablets.
FDA: XYZAL ALLERGY 24HR NDA 209089/209090 OTC-switch review materials (2017) ↗U.S. OTC switch for XYZAL ALLERGY 24HR
The NDA 209089 OTC review covers the 5 mg antihistamine tablet.
FDA: XYZAL ALLERGY 24HR NDA 209089/209090 OTC-switch review materials (2017) ↗FDA issued its severe-itching-after-stopping communication
The communication covers prescription and OTC oral cetirizine/levocetirizine and requires label updates.
FDA: 16 May 2025 drug safety communication on rare but potentially severe itching after stopping long-term oral cetirizine or levocetirizine ↗
MARKET SCOPE
Market-record boundary
U.S. prescription
Current public label5 mg tablets and 0.5 mg/mL oral solution; NDA 022064/022157.
U.S. OTC
Current Drug Facts and package recordsXYZAL ALLERGY 24HR 5 mg tablets; NDA 209089.
Outside the United States
Local products not established in this dossierCheck the local regulator and pack in hand; do not carry U.S. OTC/prescription boundaries across markets.
How to read this record
Read each document in its stated market, date and dosage-form context. A historical record is not a current label and does not support individual medical, substitution or purchasing conclusions.
Keep international and mainland China records separate
This page has a U.S. public history/regulatory archive but no mainland China record for this specific product. That does not establish whether the medicine exists, is approved or is available in mainland China. Verify product identity, dosage form, strength, holder and the current label item by item.
RECORD FAQ
Record questions
Does 5 mg always mean one tablet a day?
No. Five mg is the labelled amount in one tablet. Whether to use it, tablet count, frequency and splitting depend on the exact product, market, age, kidney function and professional review; the site does not turn strength into a prescription.
Can it be taken with ZYRTEC, cetirizine or another allergy medicine?
A website cannot make that decision. Related names, class or mechanism do not permit combination, rotation or conversion. Give a pharmacist or clinician the full ingredient lists for every prescription and OTC cold/allergy product to check for duplication.
Can long-term daily use be stopped suddenly?
FDA warns that rare but severe itching can occur after stopping long-term regular use, but the communication is not a website taper or restart plan. Discuss planned long-term use or stopping with a professional, and seek prompt help for severe itching after stopping.
READ NEXT
Related reading
Evidence status
The listed links are public sources selected for traceability. They must be rechecked against the current target-market record before any use beyond reading and research.