Label: CHILDRENS CETIRIZINE HYDROCHLORIDE- cetirizine hcl solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 12, 2024

If you are a consumer or patient please visit this version.

View All Sections
  • 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?

    1-800-616-2471

    DISTRIBUTED BY:

    ATLANTIC BIOLOGICALS CORP.

    MIAMI, FL 33179

  • Package/Label Principal Display Panel

    Children’s Cetirizine Hydrochloride Oral Solution 1 mg/mL

    Antihistamine

    ALLERGY

    INDOOR & OUTDOOR ALLERGIES

    24 HOUR RELIEF OF:

    Sneezing / Runny Nose

    Itchy, Watery Eyes / Itchy Throat or Nose

    2yrs & older

    Dosing Cup Included

    Dye-Free

    Sugar-Free

    Grape Flavored Syrup

    image description

    image description

  • INGREDIENTS AND APPEARANCE
    CHILDRENS CETIRIZINE HYDROCHLORIDE 
    cetirizine hcl solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17856-6765(NDC:0904-6765)
    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:17856-6765-172 in 1 BOX, UNIT-DOSE12/12/2024
    1NDC:17856-6765-25 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20422608/22/2018
    Labeler - ATLANTIC BIOLOGICALS CORP. (047437707)
    Establishment
    NameAddressID/FEIBusiness Operations
    UNIT DOSE SOLUTION360804194repack(17856-6765)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!