Label: LEVOCETIRIZINE DIHYDROCHLORIDE- levocetirizine dihydrochloride tablet

  • NDC Code(s): 42571-312-11, 42571-312-18, 42571-312-32, 42571-312-53, view more
    42571-312-90
  • Packager: Micro Labs Limited
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 7, 2019

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  • Active ingredient (in each tablet)

    Levocetirizine dihydrochloride USP 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).

  • 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 OR PHARMACIST BEFORE USE IF

  • KEEP OUT OF REACH OF CHILDREN

  • 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 than1 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


  • STORAGE

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

  • Inactive ingredients

    hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, silicon dioxide, and titanium dioxide

  • Questions or comments?

    call 1-855-839-8195



  • PRINCIPAL DISPLAY PANEL


    MICRO LABS LIMITED
    Container

    NDC- 42571-312-90
    Levocetirizine dihydrochloride Tablets USP
    5mg
    Antihistamine

    90 Tablets    MICRO LABS
    micro container label
    Container-Carton



    NDC- 42571-312-90
    Levocetirizine dihydrochloride Tablets USP
    5mg
    Antihistamine

    90 Tablets    MICRO LABS
    micro carton label

    INVATECH PHARMA SOLUTIONS LLC
    Container




    NDC- 42571-312-90
    Levocetirizine dihydrochloride Tablets USP
    5mg
    Antihistamine

    90 Tablets    MICRO LABS
    invatech container label
    Container-Carton



    NDC- 42571-312-90
    Levocetirizine dihydrochloride Tablets USP
    5mg
    Antihistamine

    90 Tablets    MICRO LABS
    invatech carton label

  • INGREDIENTS AND APPEARANCE
    LEVOCETIRIZINE DIHYDROCHLORIDE  
    levocetirizine dihydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42571-312
    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
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    Product Characteristics
    Colorwhite (White to off-white) Score2 pieces
    ShapeOVALSize8mm
    FlavorImprint Code LI
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42571-312-532500 in 1 POUCH; Type 0: Not a Combination Product02/01/2019
    2NDC:42571-312-901 in 1 CARTON02/01/2019
    290 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:42571-312-11100 in 1 CARTON02/01/2019
    3NDC:42571-312-3210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    4NDC:42571-312-181 in 1 CARTON02/01/2019
    410 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21155102/01/2019
    Labeler - Micro Labs Limited (862174955)
    Establishment
    NameAddressID/FEIBusiness Operations
    InvaTech Pharma Solutions LLC078602180manufacture(42571-312)
    Establishment
    NameAddressID/FEIBusiness Operations
    Micro Labs Limited915793658manufacture(42571-312)
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