Label: ALLERGY RELIEF- cetirizine hcl tablet

  • NDC Code(s): 72090-028-20
  • Packager: Pioneer Life Sciences, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 27, 2023

If you are a consumer or patient please visit this version.

  • Active Ingredient (in each caplet)

    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 DOCTOR

    Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.

  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

  • WHEN USING

    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

    Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding:
    • if breast-feeding: not recommended
    • if pregnant: ask a health professional before use

  • KEEP OUT OF REACH OF CHILDREN

    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 older: 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 lnfonnation

    • Store between 20°Cto 25°C(68°F to 77°F)
  • Inactive Ingredients

    Lactose, Povidone, Maize Starch, Magnesium Stearate, Opadry White, Titanium Dioxide, Hypromellose, Polyethylene Glycol

  • Questions or Comments?

    Call 1-732-698-5070 Mon-Fri, 9am-5pm EST.

  • Package Label

    PL0151 Rev 00 Cetirizine HCL 10mg 200ct-Unique-09.08.23

  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF 
    cetirizine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72090-028
    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)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POVIDONE (UNII: FZ989GH94E)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeBULLET (Barrel shape) Size8mm
    FlavorImprint Code CTN;10
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72090-028-20200 in 1 BOTTLE; Type 0: Not a Combination Product10/26/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07782910/26/2023
    Labeler - Pioneer Life Sciences, LLC (014092742)