Label: CETIRIZINE- cetirizine hydrochloride tablet, film coated

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 26, 2019

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  • 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?

    1-800-719-9260

  • Repackaging Information

    Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:

    Count10 mg
    9071610-123-60

    Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.

    Repackaged by:
    Aphena Pharma Solutions - TN
    Cookeville, TN 38506

    20180905JH

  • PRINCIPAL DISPLAY PANEL - 10 mg

    NDC 71610-123 - Cetirizine HCl 10 mg - Rx Only
    Bottle Label 10 mg

  • INGREDIENTS AND APPEARANCE
    CETIRIZINE 
    cetirizine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71610-123(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:71610-123-6090 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/17/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07833606/29/2018
    Labeler - Aphena Pharma Solutions - Tennessee, LLC (128385585)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aphena Pharma Solutions - Tennessee, LLC128385585REPACK(71610-123)
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