Levocetirizine 5 mg Tablets — Generic For Xyzal — Glenmark

These highlights do not include all the information needed to use LEVOCETIRIZINE DIHYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for LEVOCETIRIZINE DIHYDROCHLORIDE TABLETS.

LEVOCETIRIZINE DIHYDROCHLORIDE tablets, for oral use

Initial U.S. Approval: 1995

Recent Major Changes

Warnings and Precautions, Risk of New Onset Pruritus After Discontinuation

Of Levocetirizine Dihydrochloride Tablets (5.3) 04/2025

Indications And Usage

Levocetirizine dihydrochloride tablets are a histamine H1-receptor antagonist indicated for:

Dosage And Administration

Chronic Idiopathic Urticaria (2.2)

Adjust the dose in patients 12 years of age and older with decreased renal function (12.3)

Dosage Forms And Strengths

Contraindications

Warnings And Precautions

• , Risk of New Onset Pruritus After Discontinuation Of Levocetirizine Dihydrochloride Tablets (5.3) 04/2025 INDICATIONS AND USAGE Levocetirizine dihydrochloride tablets are a histamine H1-receptor antagonist indicated for:
• The relief of symptoms associated with perennial allergic rhinitis (1.1)
• The treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria (1.2) DOSAGE AND ADMINISTRATION 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) DOSAGE FORMS AND STRENGTHS
• Immediate release breakable (scored) tablets, 5 mg (3) CONTRAINDICATIONS
• Patients with a known hypersensitivity to levocetirizine or any of the ingredients of levocetirizine dihydrochloride tablets or to cetirizine (4.1)

• , Risk of New Onset Pruritus After Discontinuation Of Levocetirizine Dihydrochloride Tablets (5.3) 04/2025 INDICATIONS AND USAGE Levocetirizine dihydrochloride tablets are a histamine H1-receptor antagonist indicated for:
• The relief of symptoms associated with perennial allergic rhinitis (1.1)
• The treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria (1.2) DOSAGE AND ADMINISTRATION 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) DOSAGE FORMS AND STRENGTHS
• Immediate release breakable (scored) tablets, 5 mg (3) CONTRAINDICATIONS
• Patients with a known hypersensitivity to levocetirizine or any of the ingredients of levocetirizine dihydrochloride tablets or to cetirizine (4.1)

Adverse Reactions

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 Glenmark Pharmaceuticals Inc., USA at 1 (888) 721-7115 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Use In Specific Populations

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).

Do not exceed the recommended dose of 2.5 mg once daily in children 6 to 11 years of age. Systemic exposure with these doses in respective pediatric age groups is comparable to that from a 5 mg once daily dose in adults. (12.3).

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 8/2025