Label: ALLERGY RELIEF- cetirizine hcl capsule

  • NDC Code(s): 33992-0741-1
  • 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 March 16, 2018

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

  • Active ingredient (in each capsule)

    Cetirizine HCl 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
    • 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

    Butylated hydroxytoluene gelatin, glycerin, mannitol, pharmaceutical ink, polyethylene glycol 400, purified water, sodium hydroxide, sorbitan, sorbitol

  • Questions or comments?

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

  • 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 10 mg

    ASSURED All Day Allergy Relief

  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF 
    cetirizine hcl capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-0741
    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)  
    MANNITOL (UNII: 3OWL53L36A)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SORBITAN (UNII: 6O92ICV9RU)  
    SORBITOL (UNII: 506T60A25R)  
    GELATIN (UNII: 2G86QN327L)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    Product Characteristics
    ColorYELLOWScoreno score
    ShapeOVALSize13mm
    FlavorImprint Code 10
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:33992-0741-11 in 1 BOX01/31/2018
    110 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20723501/31/2018
    Labeler - ASSURED / DOLLAR TREE (Greenbrier International, Inc.) (610322518)