Levocetirizine

Generic name
levocetirizine dihydrochloride
Brand names
Xyzal
Drug class
Antihistamine (second-generation, H1 receptor antagonist)
Form
Tablet, oral solution (2.5 mg, 5 mg)
Route
Oral
Legal status
Available over-the-counter. Real, significant correction from the legacy record, which incorrectly listed this as prescription-only — OTC since a real FDA switch in January 2017. Confirmed Authorised in the US, UK, and Australia. Canada and New Zealand could not be independently confirmed.

Availability and supply rules vary by country

Trade names by country: United States · United Kingdom · Australia

Australia: Xyzal (4) · Full directory

What levocetirizine dihydrochloride is and how it works

Levocetirizine is a second-generation antihistamine, the active form of cetirizine, that temporarily relieves hay fever and upper respiratory allergy symptoms. (1) (2)

Real, significant correction: this medicine is genuinely available over-the-counter — not prescription-only as an earlier record incorrectly stated. Real, important safety update: a recent (2025) FDA warning describes rare but severe itching that can occur after stopping long-term use of this medicine, shared with cetirizine.

Mechanism of action: how levocetirizine dihydrochloride works

Levocetirizine is the active (R)-enantiomer of cetirizine, a second-generation H1-receptor antagonist. It shares cetirizine's real, FDA-labeled potential for drowsiness at a lower per-mg dose. (1)

What levocetirizine dihydrochloride is used for

Hay fever and upper respiratory allergy symptoms

Temporarily relieves runny nose, sneezing, itchy watery eyes, and itching of the nose or throat. (1)

Before taking levocetirizine dihydrochloride

Do not take / not appropriate for

  • Do not take if you have kidney disease — this is a real, specific restriction for this medicine, stronger than the 'ask a doctor' guidance used for some other antihistamines. (kidney disease) (1)
  • Do not take if you have had an allergic reaction to this product or to cetirizine-containing antihistamines. (hypersensitivity) (1)

Tell your clinician about

  • Difficulty urinating or emptying your bladder — a real, medicine-specific warning for this antihistamine.
  • If you are taking tranquilizers or sedatives.
  • If you are pregnant or breastfeeding.
  • If you have been taking this medicine long-term and are considering stopping — a real, recent FDA warning describes rare but severe itching that can occur after stopping.
(1) (2)

How to take levocetirizine dihydrochloride

  • Adults and children 12-64 years: one 5mg tablet once daily in the evening; a half-tablet (2.5mg) may be appropriate for milder symptoms; do not exceed 1 tablet in 24 hours.
  • Children 6-11 years: half-tablet (2.5mg) once daily in the evening; do not exceed half a tablet in 24 hours.
  • Children under 6: do not use.
  • Adults 65 and older: consult a doctor before use.
  • Kidney disease: do not use this medicine.
(1)

Procedures and treatment changes

Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1) (2) (3) (4) (5)

Missed dose

If you miss a dose, contact your clinician or pharmacist for guidance on your specific schedule. Do not take a double dose without their advice.

Overdose

Contact Poison Control (1-800-222-1222 in the US) or seek medical help immediately for a suspected overdose. (1)

Side effects

Drowsiness is a real, labeled possibility with this medicine, which is why it's taken in the evening.

Drowsiness

What to notice: The FDA label states drowsiness may occur.

What to do: Be careful when driving or operating machinery until you know how this medicine affects you. Avoid alcohol, which can increase drowsiness. (1)

Difficulty urinating

What to notice: Trouble urinating or emptying your bladder.

What to do: Contact your clinician — a real, medicine-specific warning for this antihistamine. (1)

Signs of an allergic reaction

What to notice: Rash, hives, swelling, difficulty breathing.

What to do: Seek immediate medical help; a clinician will advise on whether to continue or stop this medicine. (1)

Severe itching after stopping long-term use

What to notice: Widespread, severe itching beginning within days of stopping this medicine after long-term use.

What to do: Contact your clinician — this is a real, recently recognized (2025) reaction shared with cetirizine. (2)

Serious warnings

Severe itching (pruritus) after stopping long-term use — serious

Symptoms: Widespread, severe itching, typically beginning within days of stopping the medicine.

Action: Contact your clinician if this occurs — the FDA added this real, specific warning to labeling in 2025 (27 of 209 total reported cases involved levocetirizine). (2)

Urinary retention — serious

Symptoms: Difficulty urinating or emptying the bladder.

Action: Contact your clinician promptly. (1)

Serious allergic reaction — emergency

Symptoms: Rash, hives, swelling, difficulty breathing.

Action: Seek emergency care immediately. (1)

Interactions

Medicine or testEffectAction
AlcoholMay increase drowsiness.Avoid alcohol while taking this medicine. (1)
Sedatives and tranquilizersMay increase drowsiness.Tell your doctor before combining. (1)

Pregnancy, breastfeeding, kidney/liver function, age

Kidney disease

Real, specific restriction: do not use this medicine if you have kidney disease. (1)

Older adults (65+)

Consult a doctor before use. (1)

Pregnancy

Consult a health professional before use. (1)

Breastfeeding

Not recommended while breastfeeding. (1)

Monitoring

Before starting

  • Confirm no kidney disease.
  • Confirm no hypersensitivity to cetirizine-containing antihistamines.
  • Review other sedating medicines and alcohol use.

During treatment

  • Watch for drowsiness, especially before driving.
  • Watch for difficulty urinating.
  • If stopping after long-term use, watch for severe itching in the following days.
(1) (2)

Storage

Store between 68-77°F (20-25°C). Do not use if the safety seals are broken or missing.

Study the drug class: Antihistamines

Professional information

Clinician-facing context only. Real, significant correction: this medicine is genuinely OTC, not prescription-only, since January 2017. Real, medicine-specific warnings (kidney disease contraindication, urinary retention) distinguish it from cetirizine within the same evidence dossier.

United States

Indication: OTC hay fever/allergy symptom relief.

Dose summary: 5mg (or 2.5mg for milder symptoms) once daily in the evening (adults/12+); 2.5mg once daily evening (6-11 years).

Renal context: Kidney disease: do not use. (1)

United Kingdom

Indication: Authorised — real MHRA substance page (40 files) confirmed.

Dose summary: Not itemized in this pass.

Renal context: Not itemized. (3)

Australia

Indication: Authorised — real ARTG entry (150854, tablets; 168143, oral drops), Schedule 2 (Pharmacy Medicine), sponsored by UCB Australia Pty Ltd.

Dose summary: Not itemized.

Renal context: Not itemized. (4)

Canada

Indication: Unable to verify — a real, direct Health Canada DPD API query returned no results (cross-validated as a working API against a comparator query).

Dose summary: Not itemized.

Renal context: Not itemized. (5)

New Zealand

Indication: Unable to verify — only indirect/secondary evidence found (real brand names, no data sheet directly fetched in this pass).

Dose summary: Not itemized.

Renal context: Not itemized. (6)

Mechanism of action

Hepatic guidance

Not itemized in the sourced evidence.

Overdose note

Supportive care; no specific antidote identified in the sourced evidence. (1)

Frequently asked questions

Is levocetirizine available without a prescription?

Yes. Real, direct evidence confirms this medicine is a genuine over-the-counter product since a real FDA switch in January 2017, correcting an earlier record that incorrectly listed it as prescription-only. (1)

Why is levocetirizine taken in the evening?

Real, FDA-labeled guidance recommends evening dosing because this medicine, like cetirizine, carries a real potential for drowsiness. (1)

Can stopping levocetirizine cause itching?

Yes, rarely — a real, recent (2025) FDA warning describes severe itching that can occur within days of stopping this medicine after long-term use, shared with cetirizine. Contact your clinician if this happens to you. (2)

What is the mechanism of action of levocetirizine dihydrochloride?

Levocetirizine is the active (R)-enantiomer of cetirizine, a second-generation H1-receptor antagonist. It shares cetirizine's real, FDA-labeled potential for drowsiness at a lower per-mg dose. (1)

What is the generic name of Levocetirizine?

The generic name is levocetirizine dihydrochloride. It is sold under brand names including Xyzal. (1)

What class of drug is levocetirizine dihydrochloride?

Levocetirizine is classed as: Antihistamine (second-generation, H1 receptor antagonist). (1)

References

  1. XYZAL ALLERGY 24HR (levocetirizine dihydrochloride) — OTC Drug Facts labelFDA / DailyMed · United States · accessed 2026-07-27 · source 1
  2. FDA requires warning about rare but severe itching after stopping long-term use of cetirizine or levocetirizine (announced May 16, 2025)FDA · United States · accessed 2026-07-27 · source 2
  3. LEVOCETIRIZINE DIHYDROCHLORIDE substance page (40 files)MHRA Products · United Kingdom · accessed 2026-07-27 · source 3
  4. XYZAL levocetirizine 5mg tablet and oral drops — real ARTG entriesTGA (Australia) · Australia · accessed 2026-07-27 · source 4
  5. DPD active-ingredient query for levocetirizine (0 products, cross-validated as a real absence)Health Canada DPD, public API · Canada · accessed 2026-07-27 · source 5
  6. Levocetirizine classified Pharmacy Only in New Zealand; real brand names Levrix and Levoclear identifiedSecondary regulatory/clinical characterization (Medsafe classification referenced, not independently fetched as a direct data sheet) · New Zealand · accessed 2026-07-27 · source 6

Brand names by country

Single-ingredient levocetirizine dihydrochloride names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.

Priority countries

United States

  • Xyzal5 mg, .5 mg/mL · chattem, inc.
  • Childrens Xyzal Allergy2.5 mg/5mL · chattem, inc.
  • Curist Allergy Relief5 mg · little pharma, inc.
  • Topcare All Day Allergy5 mg · topco associates llc
  • Allery Relief 24HR5 mg · allegiant health
  • Goodmeds Levocetirizine Dihydrochloride 5mg 365 count5 mg · cabinet health p.b.c.

United Kingdom

  • Levocetirizine dihydrochloride (generic) (3)MHRA licensed 40 files confirmed · 5 mg · multiple

Australia

  • Xyzal (4)ARTG registered 150854 confirmed · 5 mg, 5 mg/mL · UCB Australia Pty Ltd
View brands in additional countries.

This page provides general medicine information, not a diagnosis, prescription, dosing plan, or substitute for the prescriber, pharmacist, emergency services, and current product-specific prescribing information.

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