Levocetirizine Dihydrochloride Tablet
FDA Label NDC 42571-312

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Micro Labs Limited for the product Levocetirizine Dihydrochloride (NDC 42571-312). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient (in each tablet), purpose, uses, do not use, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredient (in Each Tablet)

→ Purpose

→ Uses

→ Do Not Use

→ Ask A Doctor Before Use If You Have

→ When Using This Product

→ Stop Use And Ask A Doctor If

→ If Pregnant Or Breast-feeding:

→ Keep Out Of Reach Of Children.

→ Directions

→ Storage

→ Inactive Ingredients

→ Questions Or Comments?

→ Principal Display Panel

Active Ingredient (In Each Tablet)

Levocetirizine dihydrochloride USP 5 mg

Purpose

Antihistamine

Uses

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

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

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

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).

Directions

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 than1 tablet (5 mg) in 24 hours ½ tablet (2.5 mg) once daily in the evening may be appropriate for less severe symptoms
children 6-11 years of age	take ½ tablet (2.5 mg) once daily in the evening do not take more than ½ tablet (2.5 mg) in 24 hours
children under 6 years of age	do not use
consumers with kidney disease	do not use