Label: XYZAL ALLERGY 24HR- levocetirizine dihydrochloride tablet

  • NDC Code(s): 41167-3510-0, 41167-3510-1, 41167-3510-2, 41167-3510-3, view more
    41167-3510-4
  • Packager: Chattem, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated March 14, 2017

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

  • SPL UNCLASSIFIED SECTION

    Xyzal Allergy 24HR Tablet

    Drug Facts

  • Active ingredient

    (in each tablet)

    Levocetirizine dihydrochloride 5 mg

  • Purpose

    Antihistamine

  • Uses

    temporarily relieves these symptoms due to hay fever or other respiratory allergies:

    • runny nose
    • sneezing
    • itchy, watery eyes
    • itching of the nose or throat
  • Warnings

    Do not use

    • if you have kidney disease
    • if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing cetirizine

    Ask a doctor before use if you have

    • ever had trouble urinating or emptying your bladder

    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

    • you have trouble urinating or emptying your bladder
    • 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 65 years of age and older■ ask a doctor
    adults and children 12-64 years of age ■ take 1 tablet (5 mg) once daily in the evening
    ■ do not take more than 1 tablet (5 mg) in 24 hours
    ■ ½ tablet (2.5 mg) once daily in the evening may be appropriate for less severe symptoms
    children 6-11 years of age■ take ½ tablet (2.5 mg) once daily in the evening
    ■ do not take more than ½ tablet (2.5 mg) in 24 hours
    children under 6 years of age■ do not use
    consumers with kidney disease■ do not use

    (Note: Age ranges are bolded in the draft container labeling for tablet bottle)

  • Other information

    • store between 20° and 25°C (68° and 77°F)
    • (if blister) safety sealed: do not use if carton was opened or if individual blister unit is open or torn

    (if bottled) safety sealed: do not use if carton was opened or if printed foil inner seal on bottle is torn or missing

    (if stretch card) safety sealed: do not use if sealed package was torn or opened, or if printed foil inner seal on bottle is torn or missing

  • Inactive ingredients

    Colloidal anhydrous silica, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, titanium dioxide

  • Questions or comments?

    call 1-800-633-1610

  • PRINCIPAL DISPLAY PANEL

    NDC 41167-3510-0
    XYZAL
    Allergy 24HR
    5 mg
    10 Tablets

    PRINCIPAL DISPLAY PANEL
NDC 41167-3510-0
XYZAL
Allergy 24HR
5 mg
10 Tablets

  • PRINCIPAL DISPLAY PANEL

    NDC 41167-3510-1
    XYZAL
    Allergy 24HR
    5 mg
    35 Tablets

    PRINCIPAL DISPLAY PANEL
NDC 41167-3510-1
XYZAL
Allergy 24HR
5 mg
35 Tablets

  • INGREDIENTS AND APPEARANCE
    XYZAL ALLERGY 24HR 
    levocetirizine dihydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-3510
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LEVOCETIRIZINE DIHYDROCHLORIDE (UNII: SOD6A38AGA) (LEVOCETIRIZINE - UNII:6U5EA9RT2O) LEVOCETIRIZINE DIHYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITEScore2 pieces
    ShapeOVALSize8mm
    FlavorImprint Code X;X
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41167-3510-01 in 1 CARTON03/10/2017
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:41167-3510-11 in 1 CARTON03/10/2017
    235 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:41167-3510-21 in 1 CARTON03/10/2017
    355 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:41167-3510-31 in 1 CARTON03/10/2017
    480 in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:41167-3510-42 in 1 CARTON03/10/2017
    555 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA20908903/10/2017
    Labeler - Chattem, Inc. (003336013)