Label: ALLERGY RELIEF- levocetirizine dihydrochloride tablet

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

Drug Label Information

Updated April 15, 2021

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 upper 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

    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
  • Other information

    • store between 20-25°C (68-77°F)
    • safety sealed: do not use if carton was opened or if printed foil inner seal on bottle is torn or missing
  • Inactive ingredients

    colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide

  • Questions?

    CALL 1-866-933-6337

  • PRINCIPAL DISPLAY PANEL

    01b LBL_Allergy Relief_180mg_PDP

    01b LBL_Allergy Relief_180mg_DF1

    01b LBL_Allergy Relief_180mg_DF2

  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF 
    levocetirizine dihydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73581-201
    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)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVALSize8mm
    FlavorImprint Code LL;H
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73581-201-801 in 1 BOX06/30/2020
    1180 in 1 BOTTLE; Type 0: Not a Combination Product
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21351306/30/2020
    Labeler - YYBA CORP (006339772)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hetero Labs Limited676162024manufacture(73581-201)