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Levocetirizine Dihydrochloride

5 mg · Tablet

  • Prescription only
  • Histamine-1 Receptor Antagonist
Made by
Northwind Health Company, LLC

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

At a glance

Quoted from the official label · 2026-01-01

What it is

Histamine-1 Receptor Antagonist

Used for
  • The treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria ( 1.2 ) 1.2 Chronic Idiopathic Urticaria Levocetirizine dihydrochloride tablets are indicated for the treatment of the…
The label’s usual adult dose

Adults and children 12 years of age and older: 5 mg once daily in the evening

Full directions ↓
Do not take it if

The use of levocetirizine dihydrochloride tablets is contraindicated in:

All warnings ↓
Good to know
  • Prescription only
  • FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02
62other products contain Levocetirizine Dihydrochloride — compare makers, forms and strengths

Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed

What it is for

Levocetirizine dihydrochloride is a histamine H 1 -receptor antagonist indicated for:

  • The treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria ( 1.2 ) 1.2 Chronic Idiopathic Urticaria Levocetirizine dihydrochloride tablets are indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in
  • adults and
  • children 6 years of age and older.

From the official label · 2026-01-01 · DailyMed

How it works

From this product’s own US prescribing label.

Levocetirizine, the active enantiomer of cetirizine, is an antihistamine; its principal effects are mediated via selective inhibition of H 1 receptors.

The antihistaminic activity of levocetirizine has been documented in a variety of animal and human models.

Peak level after0.9 h
Half-life8–9 h
Mostly cleared after≈ 42.5 hfive half-lives — our arithmetic
PeakHalf gone42.5 h0
The shape is a standard model drawn from the two times above, not a measurement. How fast a medicine acts and wears off also depends on the dose, the form and the person.
How the body breaks it down

The extent of metabolism of levocetirizine in humans is less than 14% of the dose and therefore differences resulting from genetic polymorphism or concomitant intake of hepatic drug metabolizing enzyme inhibitors are expected to be negligible.

How it leaves the body

This finding would also be applicable for levocetirizine, as levocetirizine and cetirizine are both predominantly excreted in urine.

With food

Food had no effect on the extent of exposure (AUC) of the levocetirizine tablet, but T max was delayed by about 1.25 hours and C max was decreased by about 36% after administration with a high fat meal; therefore, levocetirizine can be administered with or without food.

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2026-01-01

Do not take it if

  • The use of levocetirizine dihydrochloride tablets is contraindicated in:
  • Patients with a known hypersensitivity to levocetirizine or any of the ingredients of levocetirizine dihydrochloride tablets or to cetirizine ( 4.1 )
  • Patients with end-stage renal disease at less than 10 mL/min creatinine clearance or patients undergoing hemodialysis ( 4.2 )
  • Children 6 months to 11 years of age with renal impairment ( 4.3 ) 4.1 Patients with Known Hypersensitivity Patients with known hypersensitivity to levocetirizine or any of the ingredients of levocetirizine dihydrochloride tablets, or to cetirizine. Observed reactions range from urticaria to anaphylaxis [see Adverse Reactions ( 6.2 )] . 4.2 Patients with End-Stage Renal Disease Patients with end-stage renal disease (CL CR <10 mL/min) and patients undergoing hemodialysis. 4.3 Pediatric Patients with Impaired Renal Function
  • Children 6 months to 11 years of age with impaired renal function

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

  • Levocetirizine dihydrochloride tablets are available as 5 mg breakable (scored) tablets, allowing for the administration of 2.5 mg, if needed. Levocetirizine dihydrochloride tablets can be taken without regard to food consumption. Chronic Idiopathic Urticaria ( 2.2 )
  • Adults and children 12 years of age and older: 5 mg once daily in the evening
  • Children 6 to 11 years of age: 2.5 mg once daily in the evening
  • Renal Impairment Adjust the dose in patients 12 years of age and older with decreased renal function ( 12.3 ) 2.2 Chronic Idiopathic Urticaria
  • Adults and Children 12 Years of Age and Older The recommended dose of levocetirizine dihydrochloride tablets is 5 mg (1 tablet) once daily in the evening. Some patients may be adequately controlled by 2.5 mg (1/2 tablet) once daily in the evening.
  • Children 6 to 11 Years of Age The recommended dose of levocetirizine dihydrochloride tablets is 2.5 mg (1/2 tablet) once daily in the evening. The 2.5 mg dose should not be exceeded because the systemic exposure with 5 mg is approximately twice that of
  • adults [ see Clinical Pharmacology ( 12.3 ) ]. Dose Adjustment for Renal and Hepatic Impairment In
  • adults and children 12 years of age and older with:
  • Mild renal impairment (creatinine clearance [CL CR ] = 50 to 80 mL/min):
  • a dose of 2.5 mg once daily is recommended;
  • Moderate renal impairment (CL CR = 30 to 50 mL/min):
  • a dose of 2.5 mg once every other day is recommended;
  • Severe renal impairment (CL CR = 10 to 30 mL/min):
  • a dose of 2.5 mg twice weekly (administered once every 3 to 4 days) is recommended;
  • End-stage renal disease patients (CL CR <10 mL/min) and patients undergoing hemodialysis should not receive levocetirizine dihydrochloride tablets. No dose adjustment is needed in patients with solely hepatic impairment. In patients with both hepatic impairment and renal impairment, adjustment of the dose is recommended.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

  • Somnolence:
  • Somnolence, fatigue, and asthenia have been reported with use of levocetirizine dihydrochloride in some patients in clinical trials.
  • Avoid engaging in hazardous occupations requiring complete mental alertness such as driving or operating machinery when taking levocetirizine dihydrochloride.
  • Avoid concurrent use of alcohol or other central nervous system depressants with levocetirizine dihydrochloride ( 5.1 ).
  • Urinary Retention:
  • Urinary retention has been reported with use of levocetirizine dihydrochloride. Use with caution in patients with predisposing factors of urinary retention (e.g. spinal cord lesion, prostatic hyperplasia). Discontinue levocetirizine dihydrochloride if urinary retention occurs ( 5.2 ).
  • New onset pruritus within a few days after discontinuation of levocetirizine dihydrochloride has been reported, usually after long-term use (e.g., few months to years) of levocetirizine dihydrochloride. Symptoms may improve with restarting or tapering levocetirizine dihydrochloride ( 5.3 ). 5.1 Somnolence In clinical trials the occurrence of somnolence, fatigue, and asthenia has been reported in some patients under therapy with levocetirizine dihydrochloride. Patients should be cautioned against engaging in hazardous occupations requiring complete mental alertness, and motor coordination such as operating machinery or driving a motor vehicle after ingestion of levocetirizine dihydrochloride. Concurrent use of levocetirizine dihydrochloride with alcohol or other central nervous system depressants should be avoided because additional reductions in alertness and additional impairment of central nervous system performance may occur. 5.2 Urinary Retention Urinary retention has been reported post marketing with levocetirizine dihydrochloride. Levocetirizine dihydrochloride should be used with caution in patients with predisposing factors of urinary retention (e.g. spinal cord lesion, prostatic hyperplasia) as levocetirizine dihydrochloride may increase the risk of urinary retention. Discontinue levocetirizine dihydrochloride if urinary retention occurs. 5.3 Risk of New Onset Pruritus After Discontinuation of Levocetirizine Dihydrochloride Casesof pruritus after discontinuation of levocetirizine dihydrochloride have been reported in the postmarketing setting in patients where pruritus wasnotpresent before initiation of levocetirizine dihydrochloride. Pruritus occurred within a few days of discontinuing levocetirizine dihydrochloride amongpatients who used levocetirizine dihydrochloride long-term (e.g., few months to years). Reported cases of pruritus were infrequent, but some wereserious with patients experiencing widespread severe pruritus [see Adverse Reactions ( 6.2 )]. If pruritus occurs after discontinuation of levocetirizinedihydrochloride, symptoms may improve with restarting or tapering levocetirizine dihydrochloride.

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

  • Risk Summary Available data from published literature and postmarketing experience with levocetirizine use in pregnant women are insufficient to identify any drug-associated risks of miscarriage, birth defects, or adverse maternal or fetal outcomes.
  • In animal reproduction studies, there was no evidence of fetal harm with administration of levocetirizine by the oral route to pregnant rats and rabbits, during the period of organogenesis, at doses up to 390 times and 470 times, respectively, the maximum recommended human dose (MRHD) in
  • adults.
  • In rats treated during late gestation and the lactation period, cetirizine had no effects on pup development at oral doses up to approximately 60 times the MRHD in
  • adults.
  • In mice treated during late gestation and the lactation period, cetirizine administered by the oral route to the dams had no effects on pup development at a dose that was approximately 25 times the MRHD in
  • adults; however, lower pup weight gain during lactation was observed at a dose that was 95 times the MRHD in
  • adults [see Data].
  • The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
  • All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
  • In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
  • Data Animal data In embryo-fetal development studies, pregnant rats received daily doses of levocetirizine up to 200 mg/kg/day from gestation days 6 to 15 and pregnant rabbits received daily doses of levocetirizine up to 120 mg/kg/day from gestation days 6 to 18.
  • Levocetirizine produced no evidence of fetal harm in rats and rabbits at doses up to 390 and 470 times the MRHD, respectively (on a mg/m 2 basis with maternal oral doses of 200 and 120 mg/kg/day in rats and rabbits, respectively).
  • No prenatal and postnatal development (PPND) studies in animals have been conducted with levocetirizine.
  • In a PPND study conducted in mice, cetirizine was administered at oral doses up to 96 mg/kg/day from gestation day 15 through lactation day 21.
  • Cetirizine lowered pup body weight gain during lactation at an oral dose in dams that was approximately 95 times the MRHD (on a mg/m 2 basis with a maternal oral dose of 96 mg/kg/day); however, there were no effects on pup weight gain at an oral dose in dams that was approximately 25 times the MRHD (on a mg/m 2 basis with a maternal oral dose of 24 mg/kg/day).
  • In a PPND study conducted in rats, cetirizine was administered at oral doses up to 180 mg/kg/day from gestation day 17 to lactation day 22.
  • Cetirizine did not have any adverse effects on rat dams or offspring development at doses up to approximately 60 times the MRHD (on a mg/m 2 basis with a maternal oral dose of 30 mg/kg/day).
  • Cetirizine caused excessive maternal toxicity at an oral dose in dams that was approximately 350 times the MRHD (on a mg/m 2 basis with a maternal oral dose of 180 mg/kg/day).
  • IN SPECIFIC POPULATIONS
  • Renal Impairment Because levocetirizine dihydrochloride is substantially excreted by the kidneys, the risk of adverse reactions to this drug may be greater in patients with impaired renal function ( 8.6 , 12.3 ).
  • Pediatric Use
  • Do not exceed the recommended dose of 2.5 mg once daily in
  • children 6 to 11 years of age. Systemic exposure with this dose in pediatric age groups is comparable to that from a 5 mg once daily dose in
  • adults. ( 12.3 ). 8.1 Pregnancy Risk Summary Available data from published literature and postmarketing experience with levocetirizine use in pregnant women are insufficient to identify any drug-associated risks of miscarriage, birth defects, or adverse maternal or fetal outcomes. In animal reproduction studies, there was no evidence of fetal harm with administration of levocetirizine by the oral route to pregnant rats and rabbits, during the period of organogenesis, at doses up to 390 times and 470 times, respectively, the maximum recommended human dose (MRHD) in
  • adults. In rats treated during late gestation and the lactation period, cetirizine had no effects on pup development at oral doses up to approximately 60 times the MRHD in
  • adults. In mice treated during late gestation and the lactation period, cetirizine administered by the oral route to the dams had no effects on pup development at a dose that was approximately 25 times the MRHD in
  • adults; however, lower pup weight gain during lactation was observed at a dose that was 95 times the MRHD in
  • adults [see Data]. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal data In embryo-fetal development studies, pregnant rats received daily doses of levocetirizine up to 200 mg/kg/day from gestation days 6 to 15 and pregnant rabbits received daily doses of levocetirizine up to 120 mg/kg/day from gestation days 6 to 18. Levocetirizine produced no evidence of fetal harm in rats and rabbits at doses up to 390 and 470 times the MRHD, respectively (on a mg/m 2 basis with maternal oral doses of 200 and 120 mg/kg/day in rats and rabbits, respectively). No prenatal and postnatal development (PPND) studies in animals have been conducted with levocetirizine. In a PPND study conducted in mice, cetirizine was administered at oral doses up to 96 mg/kg/day from gestation day 15 through lactation day 21. Cetirizine lowered pup body weight gain during lactation at an oral dose in dams that was approximately 95 times the MRHD (on a mg/m 2 basis with a maternal oral dose of 96 mg/kg/day); however, there were no effects on pup weight gain at an oral dose in dams that was approximately 25 times the MRHD (on a mg/m 2 basis with a maternal oral dose of 24 mg/kg/day). In a PPND study conducted in rats, cetirizine was administered at oral doses up to 180 mg/kg/day from gestation day 17 to lactation day 22. Cetirizine did not have any adverse effects on rat dams or offspring development at doses up to approximately 60 times the MRHD (on a mg/m 2 basis with a maternal oral dose of 30 mg/kg/day). Cetirizine caused excessive maternal toxicity at an oral dose in dams that was approximately 350 times the MRHD (on a mg/m 2 basis with a maternal oral dose of 180 mg/kg/day). 8.2 Lactation Risk Summary There are no data on the presence of levocetirizine in human milk, the effects on the breastfed infant, or the effects on milk production. However, cetirizine has been reported to be present in human breast milk. In mice and beagle dogs, studies indicated that cetirizine was excreted in milk [see Data]. When a drug is present in animal milk, it is likely the drug will be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for levocetirizine dihydrochloride and any potential adverse effects on the breastfed child from levocetirizine dihydrochloride or from the underlying maternal condition. Data Animal data Cetirizine was detected in the milk of mice. No adverse developmental effects on pups were seen when cetirizine was administered orally to dams during lactation at a dose that was approximately 25 times the MRHD in
  • adults [see Use in Specific Populations ( 8.1 )]. Studies in beagle dogs indicated that approximately 3% of the dose of cetirizine was excreted in milk. The concentration of drug in animal milk does not necessarily predict the concentration of drug in human milk. 8.4 Pediatric Use The recommended dose of levocetirizine dihydrochloride for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in patients 6 months to 17 years of age is based on extrapolation of efficacy from
  • adults 18 years of age and older [see Clinical Studies ( 14 )] . The recommended dose of levocetirizine dihydrochloride in patients 6 months to 2 years of age for the treatment of the symptoms of perennial allergic rhinitis and 6 months to 11 years of age with chronic idiopathic urticaria is based on cross-study comparisons of the systemic exposure of levocetirizine dihydrochloride in
  • adults and pediatric patients and on the safety profile of levocetirizine dihydrochloride in both adult and pediatric patients at doses equal to or higher than the recommended dose for patients 6 months to 11 years of age. The safety of levocetirizine dihydrochloride 5 mg once daily was evaluated in 243 pediatric patients 6 to 12 years of age in two placebo-controlled clinical trials lasting 4 and 6 weeks. The safety of levocetirizine dihydrochloride 1.25 mg twice daily was evaluated in one 2-week clinical trial in 114 pediatric patients 1 to 5 years of age and the safety of levocetirizine dihydrochloride 1.25 mg once daily was evaluated in one 2-week clinical trial in 45 pediatric patients 6 to 11 months of age [see Adverse Reactions ( 6.1 )] . The effectiveness of levocetirizine dihydrochloride 1.25 mg once daily (6 months to 5 years of age) and 2.5 mg once daily (6 to 11 years of age) for the treatment of the symptoms of perennial allergic rhinitis and chronic idiopathic urticaria is supported by the extrapolation of demonstrated efficacy of levocetirizine dihydrochloride 5 mg once daily in patients 12 years of age and older based on the pharmacokinetic comparison between
  • adults and children. Cross-study comparisons indicate that administration of a 5 mg dose of levocetirizine dihydrochloride to 6 to 12 year old pediatric patients resulted in about 2-fold the systemic exposure (AUC) observed when 5 mg of levocetirizine dihydrochloride was administered to healthy
  • adults. Therefore, in
  • children 6 to 11 years of age the recommended dose of 2.5 mg once daily should not be exceeded. In a population pharmacokinetics study the administration of 1.25 mg once daily in
  • children 6 months to 5 years of age resulted in systemic exposure comparable to 5 mg once daily in
  • adults. [see Dosage and Administration ( 2.2 ), Clinical Studies ( 14 ), and Clinical Pharmacology ( 12.3 )] . 8.5 Geriatric Use Clinical studies of levocetirizine dihydrochloride for each approved indication did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently than younger patients. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy. 8.6 Renal Impairment Levocetirizine dihydrochloride is known to be substantially excreted by the kidneys and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection and it may be useful to monitor renal function [see Dosage and Administration ( 2 ) and Clinical Pharmacology ( 12.3 )] . 8.7 Hepatic Impairment As levocetirizine is mainly excreted unchanged by the kidneys, it is unlikely that the clearance of levocetirizine is significantly decreased in patients with solely hepatic impairment [see Clinical Pharmacology ( 12.3 )] .

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

  • In vitro data indicate that levocetirizine is unlikely to produce pharmacokinetic interactions through inhibition or induction of liver drug-metabolizing enzymes.
  • No in vivo drug-drug interaction studies have been performed with levocetirizine.
  • Drug interaction studies have been performed with racemic cetirizine.
  • 7.1 Antipyrine, Azithromycin, Cimetidine, Erythromycin, Ketoconazole, Theophylline, and Pseudoephedrine Pharmacokinetic interaction studies performed with racemic cetirizine demonstrated that cetirizine did not interact with antipyrine, pseudoephedrine, erythromycin, azithromycin, ketoconazole, and cimetidine.
  • There was a small decrease (~16%) in the clearance of cetirizine caused by a 400 mg dose of theophylline.
  • It is possible that higher theophylline doses could have a greater effect.
  • 7.2 Ritonavir Ritonavir increased the plasma AUC of cetirizine by about 42% accompanied by an increase in half-life (53%) and a decrease in clearance (29%) of cetirizine.
  • The disposition of ritonavir was not altered by concomitant cetirizine administration.

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

  • Overdosage has been reported with levocetirizine dihydrochloride.
  • Symptoms of overdose may include drowsiness in adults.
  • In children agitation and restlessness may initially occur, followed by drowsiness.
  • There is no known specific antidote to levocetirizine dihydrochloride.
  • Should overdose occur, symptomatic or supportive treatment is recommended.
  • Levocetirizine dihydrochloride is not effectively removed by dialysis, and dialysis will be ineffective unless a dialyzable agent has been concomitantly ingested.
  • The acute maximal non-lethal oral dose of levocetirizine was 240 mg/kg in mice (approximately 190 times the maximum recommended daily oral dose in
  • adults, approximately 230 times the maximum recommended daily oral dose in
  • children 6 to 11 years of age, and approximately 180 times the maximum recommended daily oral dose in
  • children 6 months to 5 years of age on a mg/m 2 basis).
  • In rats the maximal non-lethal oral dose was 240 mg/kg (approximately 390 times the maximum recommended daily oral dose in
  • adults, approximately 460 times the maximum recommended daily oral dose in
  • children 6 to 11 years of age, and approximately 370 times the maximum recommended daily oral dose in
  • children 6 months to 5 years of age on a mg/m 2 basis).

Quoted from the official label, section “Overdosage”.

Use in children

  • The recommended dose of levocetirizine dihydrochloride for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in patients 6 months to 17 years of age is based on extrapolation of efficacy from
  • adults 18 years of age and older [see Clinical Studies ( 14 )] .
  • The recommended dose of levocetirizine dihydrochloride in patients 6 months to 2 years of age for the treatment of the symptoms of perennial allergic rhinitis and 6 months to 11 years of age with chronic idiopathic urticaria is based on cross-study comparisons of the systemic exposure of levocetirizine dihydrochloride in
  • adults and pediatric patients and on the safety profile of levocetirizine dihydrochloride in both adult and pediatric patients at doses equal to or higher than the recommended dose for patients 6 months to 11 years of age.
  • The safety of levocetirizine dihydrochloride 5 mg once daily was evaluated in 243 pediatric patients 6 to 12 years of age in two placebo-controlled clinical trials lasting 4 and 6 weeks.
  • The safety of levocetirizine dihydrochloride 1.25 mg twice daily was evaluated in one 2-week clinical trial in 114 pediatric patients 1 to 5 years of age and the safety of levocetirizine dihydrochloride 1.25 mg once daily was evaluated in one 2-week clinical trial in 45 pediatric patients 6 to 11 months of age [see Adverse Reactions ( 6.1 )] .
  • The effectiveness of levocetirizine dihydrochloride 1.25 mg once daily (6 months to 5 years of age) and 2.5 mg once daily (6 to 11 years of age) for the treatment of the symptoms of perennial allergic rhinitis and chronic idiopathic urticaria is supported by the extrapolation of demonstrated efficacy of levocetirizine dihydrochloride 5 mg once daily in patients 12 years of age and older based on the pharmacokinetic comparison between
  • adults and children.
  • Cross-study comparisons indicate that administration of a 5 mg dose of levocetirizine dihydrochloride to 6 to 12 year old pediatric patients resulted in about 2-fold the systemic exposure (AUC) observed when 5 mg of levocetirizine dihydrochloride was administered to healthy
  • adults.
  • Therefore, in
  • children 6 to 11 years of age the recommended dose of 2.5 mg once daily should not be exceeded.
  • In a population pharmacokinetics study the administration of 1.25 mg once daily in
  • children 6 months to 5 years of age resulted in systemic exposure comparable to 5 mg once daily in
  • adults. [see Dosage and Administration ( 2.2 ), Clinical Studies ( 14 ), and Clinical Pharmacology ( 12.3 )] .

Quoted from the official label, section “Pediatric Use”.

Use in older people

  • Clinical studies of levocetirizine dihydrochloride for each approved indication did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently than younger patients.
  • Other reported clinical experience has not identified differences in responses between the elderly and younger patients.
  • In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy.

Quoted from the official label, section “Geriatric Use”.

Side effects

  • The following clinically significant adverse reactions are described elsewhere in the labeling:
  • Somnolence [see Warnings and Precautions ( 5.1 )]
  • Urinary Retention [see Warnings and Precautions ( 5.2 )]
  • Risk of New Onset Pruritus After Discontinuation of Levocetirizine Dihydrochloride [see Warnings and Precautions ( 5.3 )] The most common adverse reactions (rate ≥2% and > placebo) were somnolence, nasopharyngitis, fatigue, dry mouth, and pharyngitis in subjects 12 years of age and older, and pyrexia, somnolence, cough, and epistaxis in
  • children 6 to 12 years of age. In subjects 1 to 5 years of age, the most common adverse reactions (rate ≥2% and > placebo) were pyrexia, diarrhea, vomiting, and otitis media. In subjects 6 to 11 months of age, the most common adverse reactions (rate ≥3% and > placebo) were diarrhea and constipation. ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Hetero Labs Limited at 1-866-495-1995 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety data described below reflect exposure to levocetirizine dihydrochloride in 2,708 patients with allergic rhinitis or chronic idiopathic urticaria in 14 controlled clinical trials of 1 week to 6 months duration. The short-term (exposure up to 6 weeks) safety data for
  • adults and adolescents are based upon eight clinical trials in which 1,896 patients (825 males and 1,071 females aged 12 years and older) were treated with levocetirizine dihydrochloride 2.5, 5, or 10 mg once daily in the evening. The short-term safety data from pediatric patients are based upon two clinical trials in which 243 children with allergic rhinitis (162 males and 81 females 6 to 12 years of age) were treated with levocetirizine dihydrochloride 5 mg once daily for 4 to 6 weeks, one clinical trial in which 114 children (65 males and 49 females 1 to 5 years of age) with allergic rhinitis or chronic idiopathic urticaria were treated with levocetirizine dihydrochloride 1.25 mg twice daily for 2 weeks, and one clinical trial in which 45 children (28 males and 17 females 6 to 11 months of age) with symptoms of allergic rhinitis or chronic urticaria were treated with levocetirizine dihydrochloride 1.25 mg once daily for 2 weeks. The long-term (exposure of 4 or 6 months) safety data in
  • adults and adolescents are based upon two clinical trials in which 428 patients (190 males and 238 females) with allergic rhinitis were exposed to treatment with levocetirizine dihydrochloride 5 mg once daily. Long term safety data are also available from an 18-month trial in 255 levocetirizine dihydrochloride-treated subjects 12 to 24 months of age. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trial of another drug and may not reflect the rates observed in practice.
  • Adults and Adolescents 12 years of Age and Older In studies up to 6 weeks in duration, the mean age of the adult and adolescent patients was 32 years, 44% of the patients were men and 56% were women, and the large majority (more than 90%) was Caucasian. In these trials 43% and 42% of the subjects in the levocetirizine dihydrochloride 2.5 mg and 5 mg groups, respectively, had at least one adverse event compared to 43% in the placebo group. In placebo-controlled trials of 1 to 6 weeks in duration, the most common adverse reactions were somnolence, nasopharyngitis, fatigue, dry mouth, and pharyngitis, and most were mild to moderate in intensity. Somnolence with levocetirizine dihydrochloride showed dose ordering between tested doses of 2.5, 5 and 10 mg and was the most common adverse reaction leading to discontinuation (0.5%). Table 1 lists adverse reactions that were reported in greater than or equal to 2% of subjects aged 12 years and older exposed to levocetirizine dihydrochloride 2.5 mg or 5 mg in eight placebo-controlled clinical trials and that were more common with levocetirizine dihydrochloride than placebo. Table 1:
  • Adverse Reactions Reported in ≥ 2%* of Subjects Aged 12 Years and Older Exposed to Levocetirizine Dihydrochloride 2.5 mg or 5 mg Once Daily in Placebo-Controlled Clinical Trials 1 to 6 Weeks in Duration Adverse Reactions Levocetirizine dihydrochloride 2.5 mg (n = 421) Levocetirizine dihydrochloride 5 mg (n = 1,070) Placebo (n = 912) Somnolence 22 (5%) 61 (6%) 16 (2%) Nasopharyngitis 25 (6%) 40 (4%) 28 (3%) Fatigue 5 (1%) 46 (4%) 20 (2%) Dry Mouth 12 (3%) 26 (2%) 11 (1%) Pharyngitis 10 (2%) 12 (1%) 9 (1%) * Rounded to the closest unit percentage Additional adverse reactions of medical significance observed at a higher incidence than in placebo in
  • adults and adolescents aged 12 years and older exposed to levocetirizine dihydrochloride are syncope (0.2%) and weight increased (0.5%). Pediatric Patients 6 to 12 Years of Age A total of 243 pediatric patients 6 to 12 years of age received levocetirizine dihydrochloride 5 mg once daily in two short-term placebo controlled double-blind trials. The mean age of the patients was 9.8 years, 79 (32%) were 6 to 8 years of age, and 50% were Caucasian. Table 2 lists adverse reactions that were reported in greater than or equal to 2% of subjects aged 6 to 12 years exposed to levocetirizine dihydrochloride 5 mg in placebo-controlled clinical trials and that were more common with levocetirizine dihydrochloride than placebo. Table 2:
  • Adverse Reactions Reported in ≥2%* of Subjects Aged 6 to 12 Years Exposed to Levocetirizine Dihydrochloride 5 mg Once Daily in Placebo-Controlled Clinical Trials 4 and 6 Weeks in Duration Adverse Reactions Levocetirizine Dihydrochloride 5 mg (n = 243) Placebo (n = 240) Pyrexia 10 (4%) 5 (2%) Cough 8 (3%) 2 (<1%) Somnolence 7 (3%) 1 (<1%) Epistaxis 6 (2%) 1 (<1%) * Rounded to the closest unit percentage Pediatric Patients 1 to 5 Years of Age A total of 114 pediatric patients 1 to 5 years of age received levocetirizine dihydrochloride 1.25 mg twice daily in a two week placebo-controlled double-blind safety trial. The mean age of the patients was 3.8 years, 32% were 1 to 2 years of age, 71% were Caucasian and 18% were Black. Table 3 lists adverse reactions that were reported in greater than or equal to 2% of subjects aged 1 to 5 years exposed to levocetirizine dihydrochloride 1.25 mg twice daily in the placebo-controlled safety trial and that were more common with levocetirizine dihydrochloride than placebo. Table 3:
  • Adverse Reactions Reported in ≥2%* of Subjects Aged 1 to 5 Years Exposed to Levocetirizine Dihydrochloride 1.25 mg Twice Daily in a 2-Week Placebo-Controlled Clinical Trial Adverse Reactions Levocetirizine Dihydrochloride 1.25 mg Twice Daily (n = 114) Placebo (n = 59) Pyrexia 5 (4%) 1 (2%) Diarrhea 4 (4%) 2 (3%) Vomiting 4 (4%) 2 (3%) Otitis Media 3 (3%) 0 (0%) * Rounded to the closest unit percentage Pediatric Patients 6 to 11 Months of Age A total of 45 pediatric patients 6 to 11 months of age received levocetirizine dihydrochloride 1.25 mg once daily in a two week placebo-controlled double-blind safety trial. The mean age of the patients was 9 months, 51% were Caucasian and 31% were Black. Adverse reactions that were reported in more than 1 subject (i.e. greater than or equal to 3% of subjects) aged 6 to 11 months exposed to levocetirizine dihydrochloride 1.25 mg once daily in the placebo-controlled safety trial and that were more common with levocetirizine dihydrochloride than placebo included diarrhea and constipation which were reported in 6 (13%) and 1 (4%) and 3 (7%) and 1 (4%) children in the levocetirizine dihydrochloride and placebo-treated groups, respectively. Long-Term Clinical Trials Experience In two controlled clinical trials, 428 patients (190 males and 238 females) aged 12 years and older were treated with levocetirizine dihydrochloride 5 mg once daily for 4 or 6 months. The patient characteristics and the safety profile were similar to that seen in the short-term studies. Ten (2.3%) patients treated with levocetirizine dihydrochloride discontinued because of somnolence, fatigue or asthenia compared to 2 (<1%) in the placebo group. There are no long term clinical trials in children below 12 years of age with allergic rhinitis or chronic idiopathic urticaria. Laboratory Test Abnormalities Elevations of blood bilirubin and transaminases were reported in <1% of patients in the clinical trials. The elevations were transient and did not lead to discontinuation in any patient. 6.2 Postmarketing Experience In addition to the adverse reactions reported during clinical trials and listed above, the following adverse reactions have also been identified during post-approval use of levocetirizine dihydrochloride. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
  • Cardiac disorders : palpitations, tachycardia
  • Ear and labyrinth disorders : vertigo
  • Eye disorders : blurred vision, visual disturbances
  • Gastrointestinal disorders : nausea, vomiting
  • General disorders and administration site conditions : edema
  • Hepatobiliary disorders : hepatitis
  • Immune system disorders : anaphylaxis and hypersensitivity
  • Metabolism and nutrition disorders : increased appetite
  • Musculoskeletal, connective tissues, and bone disorders : arthralgia, myalgia
  • Nervous system disorders :
  • dizziness, dysgeusia, febrile seizure, movement disorders (including dystonia and oculogyric crisis), paresthesia, seizure (reported in subjects with and without a known seizure disorder), tremor
  • Psychiatric disorders :
  • aggression and agitation, depression, hallucinations, insomnia, nightmare, suicidal ideation
  • Renal and urinary disorders : dysuria, urinary retention
  • Respiratory, thoracic, and mediastinal disorders :
  • dyspnea Skin and subcutaneous tissue disorders:
  • angioedema, fixed drug eruption, pruritus, rash, urticaria, and new onset pruritus within a few days after discontinuation of levocetirizine dihydrochloride, usually after long-term use (e.g., few months to years) of levocetirizine dihydrochloride. Besides these reactions reported under treatment with levocetirizine dihydrochloride, other potentially severe adverse reactions have been reported from the post-marketing experience with cetirizine. Since levocetirizine is the principal pharmacologically active component of cetirizine, one should take into account the fact that the following adverse reactions could also potentially occur under treatment with levocetirizine dihydrochloride.
  • Cardiac disorders : severe hypotension
  • Gastrointestinal disorders : cholestasis
  • Nervous system disorders : extrapyramidal symptoms, myoclonus, orofacial dyskinesia, tic
  • Pregnancy, puerperium and perinatal conditions : stillbirth
  • Renal and urinary disorders : glomerulonephritis
  • Skin and subcutaneous tissue disorders :
  • acute generalized exanthematous pustulosis (AGEP)

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

  • Somnolence Caution patients against engaging in hazardous occupations requiring complete mental alertness, and motor coordination such as operating machinery or driving a motor vehicle after ingestion of levocetirizine dihydrochloride [see Warnings and Precautions ( 5.1 )].
  • Concomitant Use of Alcohol and other Central Nervous System Depressants Instruct patients to
  • avoid concurrent use of levocetirizine dihydrochloride with alcohol or other central nervous system depressants because additional reduction in mental alertness may occur [see Warnings and Precautions ( 5.1 )].
  • Risk of New Onset Pruritus After Discontinuation of Levocetirizine Dihydrochloride Inform patients pruritus has occurred within a few days of discontinuing levocetirizine dihydrochloride among patients who used levocetirizine dihydrochloride long-term (e.g., few months to years).
  • Pruritus may improve with restarting or tapering levocetirizine dihydrochloride [see Warnings and Precautions ( 5.3 )] .
  • Advise patients to seek medical advice if pruritus occurs.
  • Dosing of Levocetirizine Dihydrochloride
  • Do not exceed the recommended daily dose in
  • adults and adolescents 12 years of age and older of 5 mg once daily in the evening.
  • In
  • children 6 to 11 years of age the recommended dose is 2.5 mg once daily in the evening.
  • Advise patients to not ingest more than the recommended dose of levocetirizine dihydrochloride because of the increased risk of somnolence at higher doses.
  • Manufactured for:
  • Camber Pharmaceuticals, Inc., Piscataway, NJ 08854 By:
  • HETERO TM Hetero Labs Limited Jeedimetla, Hyderabad-500055, India or By:
  • Annora Pharma Pvt.
  • Ltd Sangareddy - 502313, Telangana, India Revised: 08/2025 camberlogo

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

  • FORMS AND STRENGTHS Levocetirizine dihydrochloride tablets, USP are white film coated, scored, round, biconvex tablets, debossed with '161' on one side and 'H' on other side.
  • Immediate release breakable (scored) tablets, 5 mg ( 3 )

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

  • Levocetirizine dihydrochloride tablets, USP 5 mg are white film coated, scored, round, biconvex tablets, debossed with '161' on one side and 'H' on other side.
  • They are supplied in Bottles of 30 Tablets (NDC 51655-148-52) Storage:
  • Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Quoted from the official label, section “How Supplied”.

What is in it

  • Levocetirizine dihydrochloride, the active component of levocetirizine dihydrochloride tablets, is an orally active H 1 -receptor antagonist. The chemical name is (R)-[2-[4-[(4-chlorophenyl) phenylmethyl]-1-piperazinyl] ethoxy] acetic acid dihydrochloride. Levocetirizine dihydrochloride is the R enantiomer of cetirizine hydrochloride, a racemic compound with antihistaminic properties. The empirical formula of levocetirizine dihydrochloride is C 21 H 25 ClN 2 O 3
  • 2HCl. The molecular weight is 461.82 and the chemical structure is shown below:
  • Levocetirizine dihydrochloride USP is white to almost white powder and is freely soluble in water and in methanol. Levocetirizine dihydrochloride tablets, USP 5 mg are white film coated, scored, round, biconvex tablets for oral administration. Inactive ingredients are:
  • colloidal silicon dioxide, lactose monohydrate, magnesium stearate and microcrystalline cellulose and opadry white YS-1-7003 which contains hypromellose, polyethylene glycol, polysorbate 80 and titanium dioxide. levocitirizinestructure

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

  • Lactoselactose monohydrateMilk sugar: matters with lactose intolerance or a milk allergy.
  • Titanium dioxidetitanium dioxideA whitening agent no longer allowed in food in the EU (E171).

Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.

Every version of this medicine (57)

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Details

Made byNorthwind Health Company, LLC
Active substanceLevocetirizine Dihydrochloride
Used inBreathing, airways, allergies and cough
Strength5 mg
FormTablet
RouteOral
Packs30 TABLET in 1 BOTTLE, PLASTIC
NDC51655-148
NDC51655-564

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Other strengths and forms

46 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

24hr Allergy Relief5 mgWithout prescriptionTablet, Coated LEADER/ Cardinal Health 110, Inc. · Levocetirizine DihydrochlorideAllergy Relief5 mgWithout prescriptionTablet, Film Coated Walgreen Company · Levocetirizine DihydrochlorideAllergy Relief5 mgWithout prescriptionTablet, Film Coated Rite Aid Corporation · Levocetirizine DihydrochlorideAllergy Relief5 mgWithout prescriptionTablet, Coated Albertsons Companies · Levocetirizine DihydrochlorideAllergy Relief5 mgWithout prescriptionTablet, Film Coated Meijer Distribution Inc · Levocetirizine DihydrochlorideAllergy Relief5 mgWithout prescriptionTablet, Coated AMERISOURCEBERGEN DRUG CORPORATION · Levocetirizine Dihydrochloride

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