Label: ALLERGY RELIEF- cetirizine hcl 10 mg tablet

  • NDC Code(s): 33992-3962-8
  • Packager: Greenbrier International
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated September 23, 2019

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  • Active ingredient

    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 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 drivinga motor vehicle or operating machinery

    Stop use and ask doctor if

    an allergic reaction to this product occurs. Seek medical help right away.

    If pregnant or breast-feeding

    If pregnant or breast-feeding, ask a health professional before use.

  • Keep out of reach of children

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

  • Directions

    • Adults and children 6 years and over:
    • one 10mg tablet once daily; do not take more than one 10mg tablet in 24 hours. A 5mg 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 20°C to 25°C (68°F to 77°F )
    • do not use if blister unit is broken or torn 
  • Inactive Ingredients

    colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide

  • Questions or comments?

    Call toll free 1-888-952-0050

    Manufactured for

    A&Z Pharmaceutical, Inc.
    Hauppauge, NY 11788

  • Package/Label Principal Display Panel

    Allergy Relief

    Allergy Relief

  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF 
    cetirizine hcl 10 mg tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-3962
    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
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    Product Characteristics
    ColorWHITEScore2 pieces
    ShapeRECTANGLE (pillow-shaped) Size9mm
    FlavorImprint Code G;4
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:33992-3962-81 in 1 CARTON12/16/2014
    114 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07831712/16/2014
    Labeler - Greenbrier International (610322518)