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Generic Xyzal: Uses, Dosage & Safety Information

Generic Xyzal

Generic Xyzal

Generic Xyzal

Levocetirizine dihydrochloride
Generic Xyzal is levocetirizine, an over-the-counter antihistamine for hay fever taken once daily in the evening, with half a tablet an option for milder symptoms. It can cause drowsiness, and the OTC product must not be used by people with kidney disease or cetirizine allergy.
  • ActiveIngredient: Levocetirizine dihydrochloride
  • DosageForm: Oral tablet, oral solution
  • Dosage: 5 mg once daily in the evening
  • Indications: Seasonal and perennial allergic rhinitis; chronic idiopathic urticaria.
  • Manufacturer: Originator: UCB / Sanofi. Generics from multiple manufacturers.
  • Storage: Store at 20-25 C (68-77 F).
  • Drug Status: Over-the-Counter
Drug Status: Over-the-Counter
Description

What is generic Xyzal?

An evening tablet, and half may be enough
The Drug Facts direct levocetirizine to be taken once daily in the evening, and state that half a tablet may be appropriate for less severe symptoms.1

Generic Xyzal refers to levocetirizine dihydrochloride, sold over the counter as Xyzal Allergy 24HR and as store-brand versions with the same active ingredient.24

Levocetirizine is the active half of cetirizine, which is why anyone who has reacted to cetirizine should not use it.

Unlike loratadine, it can cause drowsiness, one reason the dose is taken in the evening.

General Instructions

How to Take generic Xyzal

Once, in the evening

Adults and children 12 to 64 take 1 tablet once daily in the evening, no more than 1 tablet in 24 hours; half a tablet may be enough for milder symptoms.1

Children 6 to 11

Children 6 to 11 take half a tablet once daily in the evening, no more than half a tablet in 24 hours; it is not for children under 6.1

Adults 65 and over

Adults 65 and over should ask a doctor before use; the right dose at that age depends on individual factors.1

Drowsiness

Avoid alcohol and take care when driving; sedatives add to the effect.1

Splitting the tablet

The tablet is scored, so it can be broken along the line to give half a dose; store the unused half in the pack and use it the next evening.1

What not to do

Do not use it after a reaction to cetirizine, and stop if you have trouble emptying your bladder.1

Side Effects

What Are the Side Effects of generic Xyzal?

Drowsiness and difficulty emptying the bladder are the effects the Drug Facts highlight.1

Reactions in the Labelling
FrequencyEffectNotes
Frequency not stated in labellingDrowsinessAvoid alcohol and driving if affected
Frequency not stated in labellingTrouble urinating or emptying the bladderStop and ask a doctor
Frequency not stated in labellingAllergic reactionStop and seek help

Source: 1

Seek immediate medical attention if:
  • Swelling of the face or throat, or difficulty breathing
  • Being unable to pass urine
  • Extreme drowsiness
Uses

What is generic Xyzal Used For?

Labelled Indications
IndicationNotes
Hay fever and other respiratory allergiesRunny nose, sneezing, itchy watery eyes, itchy nose or throat

Source: 1

The over-the-counter product treats allergy symptoms; the prescription form also treats chronic hives.1

Safety advice

Interactions Alcohol:

Unsafe
Levocetirizine adds measurably to alcohol impairment. Avoid alcohol while taking it.

Interactions Other Medications:

Consult your doctor
Additive sedation with opioids, benzodiazepines and sedatives. Direct duplication with hydroxyzine, which metabolises to cetirizine. See Interactions.

Special Groups Pregnancy:

Consult your doctor
Human data are limited. Not approved specifically for pregnancy; discuss with a clinician rather than self-treating.

Special Groups Breastfeeding:

Consult your doctor
Expected to pass into breast milk. Drowsiness in the infant is the concern.

Special Groups Elderly:

Use with caution
No adjustment by age alone, but renal function declines with age and clearance is renal. Creatinine clearance should be known before regular use.

Special Groups Children:

Consult your doctor
Approved from 6 months at reduced doses. Contraindicated in children 6 months to 11 years with any renal impairment.

Effects on Activities Driving:

Use with caution
Drowsiness is the most reported effect. Take in the evening as directed and establish your response before driving.

Effects on Activities Operating Machinery:

Use with caution
The same applies as for driving.
Regulatory status and dispensing

Levocetirizine is available over the counter as Xyzal Allergy 24HR and store brands, and on prescription for chronic hives.2

Warnings

Critical Warnings for generic Xyzal Use

Kidney disease

Contraindicated: Use of the OTC product by people with kidney disease.1

Cetirizine or levocetirizine allergy

Contraindicated: Use after an allergic reaction to this product, its ingredients or an antihistamine containing cetirizine.1

Bladder emptying

Ask a doctor first if you have ever had trouble urinating or emptying your bladder.1

Drowsiness

Drowsiness may occur; alcohol, sedatives and tranquilizers increase it.1

See Interactions.

Dosage

Dosage

generic Xyzal Products
FormulationActive IngredientsClinical Note
Tablets 5 mg (scored)Levocetirizine dihydrochlorideHalf tablet 2.5 mg possible
Kidney diseaseLevocetirizineDo not use the OTC product
Liver diseaseLevocetirizineNot addressed in the Drug Facts; ask a doctor
Children under 6LevocetirizineDo not use the OTC product

Source: 14

Exceeding the dose
Overdose mainly causes drowsiness in adults and agitation followed by drowsiness in children; contact Poison Control.1
Interactions

What Does generic Xyzal Interact With?

Levocetirizine is not expected to affect liver enzymes; the relevant interactions add drowsiness.

Interactions by Severity
Interacting SubstanceEffect and RiskSeverityDocumentation
Alcohol, sedatives, tranquilizersMore drowsinessModerateGood — labelled warning
Cetirizine and hydroxyzine productsDuplicate antihistamineModerateFair — related ingredient

Source: 1

FAQs
The Drug Facts direct evening dosing; it can cause drowsiness in some people.
Yes; the Drug Facts say half a tablet may be appropriate for less severe symptoms.
It contains the same active ingredient; store brands follow the same directions.
Not the over-the-counter product; ask a doctor.
No. Levocetirizine is part of cetirizine, so a reaction to one rules out the other.
Evidence and Reported Data

Evidence Scope

Established: levocetirizine is taken in the evening and may cause drowsiness; the OTC product is not for people with kidney disease. Unknown: side-effect frequencies, which the Drug Facts do not give.1

FDA adverse event reports

Reports involving levocetirizine are recorded in FAERS; a count of reports is not a rate.3

Who was this medicine studied in?

Xyzal predates the Drug Trials Snapshots programme.5

Where to report and verify

Routing to Official Registries
What you needWhere to go
Report a side effectFDA MedWatch
Pregnancy-specific dataMotherToBaby
Full prescribing informationDailyMed
Verify a pharmacy websiteFDA BeSafeRx · LegitScript
References

References

  1. FDA OTC Drug Facts, Xyzal Allergy 24HR (levocetirizine dihydrochloride 5 mg) (Chattem) — Uses, Warnings, Directions
    Label effective 2026-03-11 · Accessed 2026-09-28
    Used for: evening dosing, half-tablet option, kidney and cetirizine warnings.
    dailymed.nlm.nih.gov — DailyMed
  2. Drugs@FDA — Xyzal (NDA 022064) and its over-the-counter switch
    Records · Accessed 2026-09-28
    Used for: prescription-to-OTC status.
    accessdata.fda.gov — Drugs@FDA
  3. openFDA — FDA Adverse Event Reporting System, drug event query for levocetirizine
    Data cut 2026-07-30 · Accessed 2026-09-28
    Used for: report totals, serious counts and most reported terms.
    open.fda.gov — openFDA
  4. FDA National Drug Code Directory — levocetirizine listings
    Directory current · Accessed 2026-09-28
    Used for: current US marketing.
    accessdata.fda.gov — NDC Directory
  5. FDA — Drug Trials Snapshots programme scope
    Programme current · Accessed 2026-09-28
    Used for: confirmation that Snapshots cover novel drugs approved from 2015.
    fda.gov — Drug Trials Snapshots

Review cycle. Clinical review completed 28 September 2026. Next review due by 28 September 2027, or earlier if the labelling is revised.

Disclaimer

Disclaimer: The information on this site is provided for informational purposes only and is not medical advice. It does not replace professional medical consultation, diagnosis, or treatment. Do not self-medicate based on the information presented on this site. Always consult with a doctor or other qualified healthcare professional before making any decisions about your health.