Label: CETIRIZINE capsule, liquid filled

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

Drug Label Information

Updated February 3, 2021

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
    • 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 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 20° to 25°C (68° to 77°F)
    • avoid high humidity and excessive heat above 40°C (104°F)
    • 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 1-800-706-5575 Monday to Friday 9 AM to 5 PM EST

  • Principal Display Panel

    Cetirizine HCl Capsules 10 mg

    ­Antihistamine

    65 Liquid Filled Capsules/10 mg each

    Indoor & Outdoor Allergies

    24 Hour Relief of:

    • Sneezing
    • Runny Nose
    • Itchy, Watry Eyes
    • Itchy Throat or Nose

    carton65s.jpg

  • Principal Display Panel

    Cetirizine HCl Capsules 10 mg

    Antihistamine

    65 Liquid Filled Capsules/10 mg each

    Indoor & Outdoor Allergies

    ­24 Hour Relief of:

    • Sneezing
    • Runny Nose
    • Itchy, Watry Eyes
    • Itchy Throat or Nose

      Label65s

  • INGREDIENTS AND APPEARANCE
    CETIRIZINE 
    cetirizine capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60505-4668
    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
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    SORBITOL (UNII: 506T60A25R)  
    MANNITOL (UNII: 3OWL53L36A)  
    WATER (UNII: 059QF0KO0R)  
    1,4-SORBITAN (UNII: AV0YTZ4E6J)  
    SHELLAC (UNII: 46N107B71O)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    AMMONIA N-13 (UNII: 9OQO0E343Z)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Product Characteristics
    ColorYELLOW (natural) Scoreno score
    ShapeOVALSize13mm
    FlavorImprint Code 10
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60505-4668-61 in 1 CARTON04/18/201805/31/2022
    165 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20723504/18/201805/31/2022
    Labeler - Apotex Corp. (845263701)
    Registrant - Apotex Inc. (209429182)