Label: ALLERGY RELIEF- cetirizine hcl capsule

  • NDC Code(s): 56062-064-25
  • Packager: Publix Supermarkets, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 8, 2022

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  • Active Ingredient (in each capsule)

    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
  • Warning

  • 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
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • avoid alcoholic drinks
    • 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 capsule once daily; do not take more than one 10 mg capsule 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 at 20ºto 25oC (68o to 77o F)
    • avoid high humidity and excessive heat above 40o C (104o F)
    • protect from light
  • Inactive Ingredients

    Butylated hydroxytolene, gelatin, glycerin, pharmaceutical ink*, polyethylene glycol 400, purified water, sodium hydroxide, sorbitan, sorbitol

    *may contain this ingredient

  • Principal Display Panel

    *Compare to the active ingredient in Zyrtec®

    allergy relief

    CETIRIZINE HCL CAPSULES 10 mg

    ANTIHISTAMINE

    24-hour relief of:

    • Sneezing
    • Runny nose
    • Itchy, watery eyes
    • Itchy throat or nose
    • Indoor & outdoor allergies

    SOFTGELS**

    **LIQUID-FILLED CAPSULES

    *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 CARD FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

    DISTRIBUTED BY

    PUBLIX SUPER MARKETS, INC.,

    3300 PUBLIX CORPORATE PARKWAY,

    LAKELAND, FL 33811

    1-888-267-3037

  • Product Label

    Cetirizine HCl 10 mg

    PUBLIX Allergy Relief

  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF 
    cetirizine hcl capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56062-064
    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
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MANNITOL (UNII: 3OWL53L36A)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SORBITAN (UNII: 6O92ICV9RU)  
    SORBITOL (UNII: 506T60A25R)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    Product Characteristics
    Coloryellow (light) Scoreno score
    ShapeOVALSize13mm
    FlavorImprint Code C10
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:56062-064-251 in 1 BOX10/08/2021
    125 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21310510/08/2021
    Labeler - Publix Supermarkets, Inc. (006922009)
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