Label: LEVOCETIRIZINE DIHYDROCHLORIDE tablet, coated

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

Drug Label Information

Updated July 26, 2019

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

  • 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 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
    • 1/2 tablet (2.5 mg) once daily in the evening may be appropriate for less severe symptoms
    children 6-11 years of age
    • take 1/2 tablet (2.5 mg) once daily in the evening
    • do not take more than 1/2 tablet (2.5 mg) in 24 hours
    children under 6 years of age
    • do not use
    consumers with kidney disease
    • do not use

  • Other information

    • store between 20° and 25°C (68° and 77°F)
    • safety sealed: Bottle: do not use if carton was opened or if printed foil inner seal on bottle is torn or missing Blister: Do not use if seal is broken or if individualblister unit is open or torn

  • Inactive ingredients

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

  • Questions or comments?

    Call 1-888-375-3784

  • Carton Label

    Placeholder image

  • INGREDIENTS AND APPEARANCE
    LEVOCETIRIZINE DIHYDROCHLORIDE 
    levocetirizine dihydrochloride tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-126
    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
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeOVALSize9mm
    FlavorImprint Code L
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37808-126-351 in 1 BOTTLE06/15/2019
    135 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:37808-126-102 in 1 BLISTER PACK06/15/2019
    25 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21037506/15/2019
    Labeler - HEB (007924756)