Label: CHILDRENS ALLERGY RELIEF- cetirizine hydrochloride solution

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

Drug Label Information

Updated December 13, 2020

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  • Drug Facts

    Active ingredient (in each 5 mL teaspoonful)

    Cetirizine Hydrochloride USP 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
    • mL=milliliter
    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 daily. 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 20° to 25° C (68° to 77°F)

  • Inactive ingredients

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

  • Questions?

    call 1-855-274-4122

    Distributed by:
    Fred's, Inc.
    4300 NEW GETWELL RD, MEMPHIS, TN 38118
    www.fredsinc.com


    fred’s Promise Not Happy With This Product? Just Bring It Back For a Refund!


  • PACKAGE LABEL- PRINCIPAL DISPLAY PANEL 4 FL OZ (120 mL Bottle)

    NDC 55315-354-31

    fred*s
    KIDS®
    2 yrs & older

    Children's
    Allergy
    Relief
    Indoor & Outdoor
    Allergies

    Cetirizine Hydrochloride
    Oral Solution, USP 1mg/mL
    Antihistamine
    Grape Flavored Syrup

    24 Hour Relief of:
    Sneezing
    Runny Nose
    Itchy, Watery Eyes
    Itchy Nose or Throat
    Dosing Cup
    Included

    4     FL OZ (120 mL)
    Compare to
    *Children's ZYRTEC®
    PACKAGE LABEL- PRINCIPAL DISPLAY PANEL 4 FL OZ (120 mL Bottle)

  • INGREDIENTS AND APPEARANCE
    CHILDRENS ALLERGY RELIEF 
    cetirizine hydrochloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55315-354
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE1 mg  in 1 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
    ColorYELLOW (Colorless to Pale Yellow) Score    
    ShapeSize
    FlavorBANANA, GRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55315-354-311 in 1 CARTON01/31/2015
    1120 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09075001/31/2015
    Labeler - Fred's, Inc. (005866116)
    Registrant - Aurohealth LLC (078728447)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aurobindo Pharma Limited918917642MANUFACTURE(55315-354)
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