Label: LEVOCETIRIZINE DIHYDROCHLORIDE tablet, coated

  • NDC Code(s): 0363-5528-10, 0363-5528-35, 0363-5528-55, 0363-5528-80
  • Packager: Walgreens Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 11, 2019

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

View All Sections
  • 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-feding: 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)
    • (bottles only) safety sealed: do not use if carton was opened or if printed foil inner seal on bottle is torn or missing
    • (blister only) safety sealed: do not use if seal is broken or if individual blister 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

    ORIGINAL PRESCRIPTION STRENGTH
    Compare to Xyzal®Allergy 24HR active ingredient    ‡‡

    0363-5528-35

    NEW Well at Walgreens
    WALGREENS PHARMACIST RECOMMENDED‡

    ORIGINAL
    PRESCRIPTION
    STRENGTH

    Levocetirizine
    24-Hour Allergy

    Levocetirizine Dihydrochloride
    Tablets, 5 mg / Antihistamine

    Relief of:

    • Sneezing
    • Runny nose
    • Itchy nose or throat
    • Itchy, watery eyes

    24 HOUR

    35 TABLETS

    carton

  • Bottle Label

    Well at Walgreens

    NDC 0363-5528-35

    ORIGINAL
    PRESCRIPTION STRENGTH

    Levocetirizine
    24-Hour Allergy

    Levocetirizine Dihydrochloride
    Tablets, 5 mg / Antihistamine

    35 TABLETS

    bottle

  • INGREDIENTS AND APPEARANCE
    LEVOCETIRIZINE DIHYDROCHLORIDE 
    levocetirizine dihydrochloride tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-5528
    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;L
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-5528-351 in 1 CARTON03/12/201809/06/2019
    135 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:0363-5528-551 in 1 CARTON03/12/201809/06/2019
    255 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:0363-5528-801 in 1 CARTON03/12/201809/06/2019
    380 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:0363-5528-102 in 1 CARTON04/17/201809/06/2019
    45 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21037503/12/2018
    Labeler - Walgreens Company (008965063)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!