Levocetirizine Dihydrochloride is an over-the-counter medicine. The sections below reproduce one FDA label for it, named under "Label". Products in other forms, strengths or from other makers have their own labels, which can differ.
- Type
- Over the counter (OTC)
- Taken
- Oral
- Label
- Chattem, Inc., revised March 11, 2026 · full label on DailyMed
Purpose
Antihistamine
What it is used 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
Active ingredient
Levocetirizine dihydrochloride 5 mg
Do not use
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
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 a doctor if
you have trouble urinating or emptying your bladder an allergic reaction to this product occurs. Seek medical help right away.
Warnings
Do not use 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 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 a doctor if you have trouble urinating or emptying your bladder an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding: if breast-feeding: not recommended if pregnant: ask a health professional before use Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Pregnancy or breastfeeding
If pregnant or breast-feeding: if breast-feeding: not recommended if pregnant: ask a health professional before use
Keep out of reach of children
. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Dosage:
we do not reproduce dosing instructions. The right dose depends on the person and the condition and is set by the prescriber or pharmacist. Dosage section of the full label.
Levocetirizine in the news
We have not covered this medicine yet. Latest news
Recalls
No recalls matched to this medicine in FDA enforcement reports from the last 3 years (or older ones still open). Search all recalls
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Source: FDA structured product labeling, retrieved through openFDA. Label text is shown as published by the FDA, without editing; long sections are shortened, marked […]. openFDA data are not validated for clinical use — always check the current label and ask a doctor or pharmacist about your own treatment. Set ID 8be45c2a-1eca-4a00-81b9-f7babdbdcd41.