Childrens Xyzal Allergy Solution
FDA Label NDC 41167-3533

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Chattem, Inc. for the product Childrens Xyzal Allergy (NDC 41167-3533). 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 5 ml), purpose, uses, warnings, 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 5 Ml)

Levocetirizine dihydrochloride 2.5 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

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).

Directions

  • use only with enclosed dosing cup
    • adults 65 years of age and older■ ask a doctor
    adults and children 12-64 years of age■ take 5 mL or 10 mL once daily in the evening depending upon severity of symptoms
    ■ do not take more than 10 mL in 24 hours
    children 6-11 years of age■ take 5 mL once daily in the evening
    ■ do not take more than 5 mL in 24 hours
    children 2-5 years of age■ take 2.5 mL once daily in the evening
    ■ do not take more than 2.5 mL in 24 hours
    children under 2 years of age■ do not use
    consumers with kidney disease■ do not use
    Note: mL = milliliters

Other Information

  • each 5 mL contains: sodium 3 mg
  • store between 20° and 25°C (68° and 77°F)
  • safety sealed: do not use if carton was opened or if printed foil inner seal on bottle is torn or missing

Inactive Ingredients

flavor, glacial acetic acid, glycerin, maltitol solution, methylparaben, propylparaben, purified water, saccharin sodium, sodium acetate trihydrate

Questions Or Comments?

call 1-800-633-1610

Principal Display Panel

NDC 41167-3530-1
Children’s
XYZAL
Allergy 24HR
5 fl. oz.
(148 mL)
Tutti Frutti Flavor

Ndc 41167-3530-1children’sxyzalallergy 24hr5 Fl. Oz.(148 mL)tutti Frutti Flavor (Childrens Xyzal Allergy 01)

Ndc 41167-3530-1children’sxyzalallergy 24hr5 Fl. Oz.(148 mL)tutti Frutti Flavor (Childrens Xyzal Allergy 01)

Ndc 41167-3530-1children’sxyzalallergy 24hr5 Fl. Oz.(148 mL)tutti Frutti Flavor (Childrens Xyzal Allergy 01)

Ndc 41167-3530-1children’sxyzalallergy 24hr5 Fl. Oz.(148 mL)tutti Frutti Flavor (Childrens Xyzal Allergy 01)

     

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