Label: INDOOR OUTDOOR ALLERGIES- cetirizine hcl tablet

  • NDC Code(s): 63548-0739-3
  • Packager: PLD Acquisitions LLC DBA Avéma Pharma Solutions
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated February 9, 2023

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  • Active Ingredient (in each tablet)

    Cetirizine HCl 10 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, sedative, 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 pregnant: ask a health professional before use
    • If breast-feeding: not recommended

    Keep out of reach of children

    In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

     adults and children 6 years and over Take one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms.
     Adults 65 years and over  ask a doctor.
     Children under 6 years of age  ask a doctor
     Consumers with liver or kidney disease  ask a doctor
  • Other Information

    •  store between 20º to 25°C (68º to 77°F)
  • Inactive Ingredients

    corn starch, hypromellose, lactose monohydrate, macrogol, magnesium stearate,  povidone, titanium dioxide.

  • Questions or comments?


  • Principal Display Panel

    *Compare to the active ingredient in Zyrtec®

    Cetirizine HCL Tablets, USP 10 mg

    Antihistamine

    Indoor & Outdoor allergies

    24 hour relief of

    • sneezing
    • Runny nose
    • Itchy, watery eyes
    • Itchy throat or nose

    Tablets

    *This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Zyrtec®

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

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.


  • Product Label

    Cetirizine HCL 10 mg

    Cetirizine HCL Tablets

  • INGREDIENTS AND APPEARANCE
    INDOOR OUTDOOR ALLERGIES 
    cetirizine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63548-0739
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code 432
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63548-0739-31 in 1 BOX07/01/2019
    1300 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07794607/01/2019
    Labeler - PLD Acquisitions LLC DBA Avéma Pharma Solutions (804087794)
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