Label: MEDLINE- cetirizine hcl tablet

  • NDC Code(s): 53329-033-33, 53329-033-38
  • Packager: Medline Industries, LP
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated September 27, 2022

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

View All Sections
  • Active ingredient (in each tablet)

    Cetirizine HCl, USP 10 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 ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.

    Ask a doctor before use if you have

    liver or kidney disease. Your doctor should determine if you need a different dose.

    Ask a doctor or pharmacist before use

    if you are taking tranquilizers or sedatives.

    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

    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 and children 6 years and overone 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms
    adults 65 years and overask a doctor
    children under 6 years of ageask a doctor
    consumers with liver or kidney diseaseask a doctor

  • Other information

    store between 20º -25ºC (68º -77ºF)

  • Inactive ingredients

    colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, opadry white OY-58900, purified water

  • Questions or comments?

    Call toll free 1-800-MEDLINE (633-5463)

    Monday-Friday 9AM-5PM CST

  • Manufacturing Information

    Manufactrued for:

    Medline Industries, LP

    Three Lakes Drive, Northfield, IL 60093 USA

    www.medline.com

    1-800-MEDLINE (633-5463)

    REF: OTCM00015

    V1 RE22HND

  • Package Label

    Label V1 RE22HND

  • INGREDIENTS AND APPEARANCE
    MEDLINE 
    cetirizine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-033
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    WATER (UNII: 059QF0KO0R)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    Product Characteristics
    Colorwhite ((to off white)) Scoreno score
    ShapeRECTANGLE ((rounded off rectangular shaped)) Size9mm
    FlavorImprint Code G;4
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53329-033-3330 in 1 BOTTLE; Type 0: Not a Combination Product05/01/2020
    2NDC:53329-033-3890 in 1 BOTTLE; Type 0: Not a Combination Product05/01/2020
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20927405/01/2020
    Labeler - Medline Industries, LP (025460908)
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!