Label: CHILDRENS ALLERGY- cetirizine hcl liquid

  • NDC Code(s): 55910-878-04
  • Packager: Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 24, 2022

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  • Active ingredient (in each 5 mL teaspoonful)

    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
     adults and children 6 years and over 1 teaspoonful (5 mL) or 2 teaspoonfuls (10 mL) once daily depending upon severity of symptoms; do not take more than 2 teaspoonfuls (10 mL) in 24 hours.
     adults 65 years and over 1 teaspoonful (5 mL) once daily; do not take more than 1 teaspoonful (5 mL) in 24 hours
     children 2 to under 6 years of age 1/2 teaspoonful (2.5 mL) once dailly. If needed, dose can be increased to a maximum of 1 teaspoonful (5 mL) once daily or 1/2 teaspoonful (2.5 mL) every 12 hours. Do not give more than 1 teaspoonful (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 20º-25ºC (68º-77ºF)
  • Inactive ingredients

    glacial acetic acid, glycerin, grape flavor, methylparaben, propylene glycol, propylparaben, purified water, sodium acetate, sucrose

  • Questions or comments?

    Call 1-888-309-9030

  • Principal Display Panel

    Compare to the active ingredient of children's Zyrtec®**

    For Ages 2 years & older

    Children's Allergy

    Cetirizine Oral Solution 1 mg/mL Anthistamine

    • Dye-Free
    • Gluten Free
    • Indoor & Outdoor Allergies

    Fast, effective, relief of children's allergy

    Dosing cup should be washed and left to air dry after each use.

    Grape Flavor

    FL OZ (mL)

    TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

    DISTRIBUTED BY OLD EAST MAIN CO.

    100 MISSION RIDGE,

    GOODLETTSVILLE, TN 37072

  • Package Label

    Cetirizine HCl 5 mg

    DOLLAR GENERAL HEALTH Children's Allergy Grape Flavor

  • INGREDIENTS AND APPEARANCE
    CHILDRENS ALLERGY 
    cetirizine hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-878
    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
    ACETIC ACID (UNII: Q40Q9N063P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM ACETATE (UNII: 4550K0SC9B)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55910-878-04118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/30/201801/31/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09047404/30/201801/31/2025
    Labeler - Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) (068331990)
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