Label: ALLERGY RELIEF- cetirizine hcl 10 mg tablet

  • NDC Code(s): 50066-396-09, 50066-396-30, 50066-396-45, 50066-396-82
  • Packager: Genomma Labs USA, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated September 20, 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 doctor 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 octor 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
    • do not use if imprinted safety seal under cap is broken or missing
  • Inactive Ingredients

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

  • Questions or Comments

    Call toll free 1-877-994-3666
    Monday to Friday, 8 am to 6 pm

  • Package/Label Principal Display Panel

    Cetirizine 10mg Front

    Cetirizine 10mg Front

    Cetirizine 10mg Back

    Cetirizine 10mg back

  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF 
    cetirizine hcl 10 mg tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50066-396
    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
    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)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeRECTANGLE (pillow-shaped) Size9mm
    FlavorImprint Code G;4
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50066-396-8290 in 1 BOTTLE; Type 0: Not a Combination Product11/06/2020
    2NDC:50066-396-3030 in 1 BOTTLE; Type 0: Not a Combination Product11/06/2020
    3NDC:50066-396-453 in 1 CARTON09/20/201910/26/2022
    315 in 1 BLISTER PACK; Type 0: Not a Combination Product
    4NDC:50066-396-091 in 1 CARTON09/20/201910/26/2022
    410 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20927412/22/2017
    Labeler - Genomma Labs USA, Inc (832323534)
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