Label: CETIRIZINE- cetirizine hydrochloride tablet, film coated

  • NDC Code(s): 0904-6717-40, 0904-6717-41, 0904-6717-43, 0904-6717-46, view more
    0904-6717-60, 0904-6717-72, 0904-6717-86
  • Packager: Major Pharmaceuticals
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 7, 2020

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

  • Active ingredient (in each tablet)

    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 a doctor or pharmacist before use if you are

    taking tranquilizers or sedatives.

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

  • Directions

    adults and children 6 years and over

    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 information

    store between 20-25°C (68-77°F)
    do not use if printed foil under cap is broken or missing
  • Inactive ingredients

    corn starch, FD&C blue no. 1 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, polydextrose, polyethylene glycol, povidone, titanium dioxide, triacetin

  • Questions or comments?

    1-800-616-2471

  • Principal Display Panel

    Compare to active ingredient in Zyrtec®

    Original Prescription Strength

    Cetirizine

    Hydrochloride Tablets, 10 mg/Antihistamine

    All Day Allergy Relief

    INDOOR & OUTDOOR ALLERGIES

    24 HOUR RELIEF OF:

    Sneezing

    Runny Nose

    Itchy, Watery Eyes

    Itchy Throat or Nose

    Actual Size

    30 TABLETS 10 mg EACH

    all day allergy relief

  • INGREDIENTS AND APPEARANCE
    CETIRIZINE 
    cetirizine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-6717
    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
    STARCH, CORN (UNII: O8232NY3SJ)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeOVALSize10mm
    FlavorImprint Code 4H2
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0904-6717-4114 in 1 CARTON06/29/2018
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:0904-6717-431 in 1 CARTON07/03/2018
    245 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:0904-6717-40500 in 1 BOTTLE; Type 0: Not a Combination Product07/03/2018
    4NDC:0904-6717-721 in 1 CARTON07/03/2018
    4300 in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:0904-6717-601 in 1 CARTON07/03/2018
    5100 in 1 BOTTLE; Type 0: Not a Combination Product
    6NDC:0904-6717-861 in 1 CARTON07/03/2018
    690 in 1 BOTTLE; Type 0: Not a Combination Product
    7NDC:0904-6717-461 in 1 CARTON07/03/2018
    730 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07833606/29/2018
    Labeler - Major Pharmaceuticals (191427277)