Label: ALLERGY RELIEF- cetirizine hcl capsule

  • NDC Code(s): 33992-0811-2
  • Packager: ASSURED / DOLLAR TREE (Greenbrier International, Inc.)
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated September 21, 2022

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

View All Sections
  • Active ingredient (in each capsule)

    Cetirizine HCl USP10 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
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • avoid alcoholic drinks
    • 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 (1800-222-1222) right away.

  • Directions

    adults and children 6 years and overone 10 mg capsule once daily; do not take more than one 10 mg capsule 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 at 20º-25°C (68º-77°F)
    • avoid high humidity and excessive heat above 40ºC (104ºF)
    • protect from light
  • Inactive ingredients

    gelatin, medium-chain triglycerides, polyethylene glycol 400, printing ink white (isopropyl alcohol, propylene glycol, shellac resins, sodium lauryl sulphate, titanium dioxide), purified water, sodium hydroxide, sorbitan, sorbitol solution

  • Questions or comments?

    Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

  • Principal Display Panel

    COMPARE TO THE ACTIVE INGREDIENTS IN ZYRTEX®*

    ALL DAY

    Allergy Relief

    24-hour relief of indoor /outdoor allergy symptoms including:

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

    Antihistamine • Cetirizine HCI, 10 mg

    softgels**

    (**Liquid-Filled Capsules)

    *This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Zyrtec®.

    TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

    DISTRIBUTED BY

    GREENBRIER INTERNATIONAL, INC.

    500 VOLVO PARKWAY, CHESAPEAKE , VA 23320

  • Package Labeling

    Cetirizine HCI USP 10 mg

    ASSURED All Day Allergy Relief

  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF 
    cetirizine hcl capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-0811
    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
    GLYCERIN (UNII: PDC6A3C0OX)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SORBITAN (UNII: 6O92ICV9RU)  
    SORBITOL (UNII: 506T60A25R)  
    GELATIN (UNII: 2G86QN327L)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHELLAC (UNII: 46N107B71O)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeOVALSize13mm
    FlavorImprint Code 291
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:33992-0811-21 in 1 BOX09/30/2018
    112 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20529109/30/2018
    Labeler - ASSURED / DOLLAR TREE (Greenbrier International, Inc.) (610322518)
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!