Medicine guide

Levocetirizine Dihydrochloride

5 mg · Tablet, Coated

  • Available without prescription
  • Histamine-1 Receptor Antagonist
Made by
Chain Drug Marketing Association INC

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 · 2025-12-10

What it is

Antihistamine

Used for
  • Runny nose sneezing itchy, watery eyes itching of the nose or throat
How to take it

Take 1 tablet (5 mg) once daily in the evening

do not take more than 1 tablet (5 mg) in 24 hours 1/2 tablet (2.5 mg) once daily in the evening may be appropriate for less severe symptoms

Full directions ↓
Do not take it if

If you have kidney disease

All warnings ↓
Good to know
  • Sold without a prescription
  • 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

temporarily relieves these symptoms due to hay fever or other respiratory allergies:

  • runny nose sneezing itchy, watery eyes itching of the nose or throat

From the official label · 2025-12-10 · DailyMed

How it works

From the US prescribing label for the same active substance (levocetirizine dihydrochloride). It describes the substance, not this exact product.

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 · 2026-08-13

Do not take it if

  • if you have kidney disease
  • if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing cetirizine

Quoted from the official label, section “OTC — Do Not Use”.

How to take it

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

  • adults 65 years of age and older
  • ask a doctor
  • adults and children 12-64 years of age
  • take 1 tablet (5 mg) once daily in the evening
  • do not take more than 1 tablet (5 mg) in 24 hours 1/2 tablet (2.5 mg) once daily in the evening may be appropriate for less severe symptoms
  • children 6-11 years of age
  • take 1/2 tablet (2.5 mg) once daily in the evening
  • do not take more than 1/2 tablet (2.5 mg) in 24 hours
  • children under 6 years of age
  • do not use consumers with kidney disease
  • do not use

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

Ask a doctor first if

ever had trouble urinating or emptying your bladder

Quoted from the official label, section “OTC — Ask Doctor”.

Stop and get help if

  • and ask doctor
  • if you have trouble urinating or emptying your bladder an allergic reaction to this product occurs. Seek medical help right away.

Quoted from the official label, section “OTC — Stop Use”.

Other warnings

  • Do not use
  • Ask a doctor before use
  • if you have ever had trouble urinating or emptying your bladder
  • When using this product drowsiness may occur
  • avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery
  • Stop use and ask doctor
  • Seek medical help right away.
  • Keep out of reach of children.
  • drowsiness may occur
  • avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

  • If pregnant or breast-feeding:
  • if breast-feding:
  • not recommended if pregnant:
  • ask a health professional before use

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

Keep away from children

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Quoted from the official label, section “OTC — Keep Out of Reach of Children”.

What kind of medicine it is

Antihistamine

Quoted from the official label, section “OTC — Purpose”.

Other ingredients

Relevant if you react to a dye, a preservative, lactose or gluten.

colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide

Quoted from the official label, section “Inactive Ingredients”.

Questions about this product

Call 1-888-375-3784

Quoted from the official label, section “OTC — Questions”.

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)

The same active substance, strength and kind of form, from every company that sells it — with what each label lists.

Hide versions whose label lists:

Showing 57 of 57

Details

Made byChain Drug Marketing Association INC
Active substanceLevocetirizine Dihydrochloride
Used inBreathing, airways, allergies and cough
Strength5 mg
FormTablet, Coated
RouteOral
Packs1 BOTTLE in 1 CARTON / 35 TABLET, COATED in 1 BOTTLE
NDC63868-473

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).

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.