Label: TOPCARE CHILDRENS ALL DAY ALLERGY- cetirizine hcl solution

  • NDC Code(s): 36800-475-00, 36800-475-26
  • Packager: Topco Associates LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated March 8, 2022

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  • Active ingredient (in each 5 mL)

    Cetirizine HCl 5 mg

  • Purpose

    Antihistamine

  • Uses

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

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

    Do not use

    if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.

    Ask a doctor before use if you have

    liver or kidney disease. Your doctor should determine if you need a different dose.

    Ask a doctor or pharmacist before use if you are

    taking tranquilizers or sedatives.

    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

    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
    •
    find right dose on chart below
    •
    mL = milliliter

    adults and children 6 years and over

    5 mL or 10 mL once daily depending upon severity of symptoms; do not take more than 10 mL in 24 hours.

    adults 65 years and over

    5 mL once daily; do not take more than 5 mL in 24 hours.

    children 2 to under 6 years of age

    2.5 mL once daily. If needed, dose can be increased to a maximum of 5 mL once daily or 2.5 mL every 12 hours. Do not give more than 5 mL in 24 hours.

    children under 2 years of age

    ask a doctor

    consumers with liver or kidney disease

    ask a doctor
  • Other information

    •
    store between 20° to 25°C (68° to 77°F)
    •
    do not use if carton is opened, or if printed neckband is broken or missing
    •
    see bottom panel for lot number and expiration date
  • Inactive ingredients

    anhydrous citric acid, artificial grape flavor, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose

  • Questions or comments?

    1-888-423-0139

  • Package/Label Principal Display Panel

    50% MORE FREE

    TopCare® health

    COMPARE TO CHILDREN’S ZYRTEC® ACTIVE INGREDIENT

    children’s

    All-Day Allergy

    CETIRIZINE HYDROCHLORIDE ORAL SOLUTION 1 mg/mL

    ANTIHISTAMINE

    INDOOR & OUTDOOR ALLERGIES

    24 HOUR

    RELIEF OF:

    ● Sneezing

    ● Runny Nose

    ● Itchy, Watery Eyes

    ● Itchy Throat or Nose

    Dye Free & Sugar Free

    2 Years & older

    GRAPE FLAVOR

    4 + 4 FL OZ (120 mL) =

    8 FL OZ (240 mL)

    Dosing cup included

    A899888-all-day-allergy
  • INGREDIENTS AND APPEARANCE
    TOPCARE CHILDRENS ALL DAY ALLERGY 
    cetirizine hcl solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-475
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE5 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-475-261 in 1 CARTON02/02/2016
    1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:36800-475-001 in 1 CARTON11/01/2021
    2240 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20422602/02/2016
    Labeler - Topco Associates LLC (006935977)
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