Label: CETIRIZINE HYDROCHLORIDE 10 MG tablet, film coated

  • NDC Code(s): 10267-3579-1, 10267-3579-3, 10267-3579-4, 10267-3579-6, view more
    10267-3579-7
  • Packager: Contract Pharmacal Corp.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated May 28, 2025

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  • Drug Facts

    Active ingredient (in each tablet)

    Cetirizine Hydrochloride 10 mg

  • PURPOSE

    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 sedatives or tranquilizers.

    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 (1-800-222-1222) right away.

  • Directions

    Adults and children 6 years and overone 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 overask a doctor
    Children under 6 years of ageask a doctor
    Consumers with liver or kidney diseaseask a doctor

  • Other information

    store between 20° to 25°C (68° to 77°F).

  • INACTIVE INGREDIENT

    hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, polysorbate, povidone, pregelatinized starch, and titanium dioxide.

  • QUESTIONS

    1-800-231-4670

  • SPL UNCLASSIFIED SECTION

    DO NOT USE IF SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

    Manufactured by:
    Contract Pharmacal Corp.
    165 Oser Avenue
    Hauppauge, NY 11788 USA
    www.cpc.com

    * This product is not manufactured or distributed by Kenvue Brands LLC., the owner of the registered trademark Zyrtec®.

  • PRINCIPAL DISPLAY PANEL

    NDC 10267-3579-6
    *Compares to Zyrtec®Allergy Original Prescription Strength

    Allergy

    Cetirizine HCl Tablets, USP

    10mg/ Antihistamine

    Indoor & Outdoor Allergies

    24 Hour

    RELIEF OF
    • Sneezing
    • Runny Nose
    • Itchy, Watery Eyes
    • Itchy Throat or Nose

    365 Tablets

    10 mg each

    CPC label

  • INGREDIENTS AND APPEARANCE
    CETIRIZINE HYDROCHLORIDE 10 MG 
    cetirizine hydrochloride 10 mg tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10267-3579
    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)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POVIDONE K30 (UNII: U725QWY32X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUND (Biconvex) Size8mm
    FlavorImprint Code C;2
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10267-3579-31 in 1 CARTON12/31/2025
    130 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:10267-3579-71 in 1 CARTON12/31/2025
    260 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:10267-3579-11 in 1 CARTON12/31/2025
    3100 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:10267-3579-6365 in 1 BOTTLE; Type 0: Not a Combination Product04/16/2025
    5NDC:10267-3579-4100 in 1 BOTTLE; Type 0: Not a Combination Product05/31/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07604704/16/2025
    Labeler - Contract Pharmacal Corp. (057795122)
    Registrant - Contract Pharmacal Corp. (057795122)
    Establishment
    NameAddressID/FEIBusiness Operations
    Contract Pharmacal Corp.057795122pack(10267-3579) , label(10267-3579)
    Establishment
    NameAddressID/FEIBusiness Operations
    Contract Pharmacal Corp.968335112manufacture(10267-3579)
    Establishment
    NameAddressID/FEIBusiness Operations
    Contract Pharmacal Corp.968334974manufacture(10267-3579)
    Establishment
    NameAddressID/FEIBusiness Operations
    Contract Pharmacal Corp.079157508manufacture(10267-3579)
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