Label: MEMBERS MARK CETIRIZINE- cetirizine hydrochloride tablet, film coated

  • NDC Code(s): 68196-458-03, 68196-458-07, 68196-458-39, 68196-458-79, view more
    68196-458-82
  • Packager: Sam's West Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated May 29, 2019

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

  • Active ingredient (in each tablet)

    Cetirizine HCl 10 mg

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  • Purpose

    Antihistamine

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  • 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
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  • 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)

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  • 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

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  • Other information

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

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

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  • Questions or comments?

    1-800-809-0469

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  • Principal Display Panel

    Compare to Zyrtec® active ingredient

    Original Prescription Strength

    Cetirizine Hydrochloride Tablets 10 mg

    Antihistamine

    Indoor & Outdoor Allergies

    24 Hour Relief of:

    Sneezing - Runny nose - Itchy, Watery Eyes - Itchy Throat or Nose

    actual size

    400 Tablets

    Allergy

    cetirizine image
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  • INGREDIENTS AND APPEARANCE
    MEMBERS MARK CETIRIZINE 
    cetirizine hydrochloride tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:68196-458
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE 10 mg
    Inactive Ingredients
    Ingredient Name Strength
    STARCH, CORN (UNII: O8232NY3SJ)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    Color WHITE Score no score
    Shape OVAL Size 10mm
    Flavor Imprint Code 4H2
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68196-458-03 1 in 1 PACKAGE 08/11/2009 08/01/2013
    1 350 in 1 BOTTLE; Type 0: Not a Combination Product
    2 NDC:68196-458-79 400 in 1 PACKAGE; Type 0: Not a Combination Product 03/24/2008
    3 NDC:68196-458-07 370 in 1 BOTTLE; Type 0: Not a Combination Product 03/24/2008
    4 NDC:68196-458-39 30 in 1 BOTTLE; Type 0: Not a Combination Product 03/24/2008
    5 NDC:68196-458-82 200 in 1 BOTTLE; Type 0: Not a Combination Product 12/30/2015
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA078336 03/24/2008
    Labeler - Sam's West Inc (051957769)
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