Label: CETIRIZINE HYDROCHLORIDE tablet

  • NDC Code(s): 49483-682-01
  • Packager: TIME CAP LABORATORIES, INC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated May 24, 2022

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  • DRUG FACTS

  • ACTIVE INGREDIENT

    Active ingredient (in each tablet)

    Cetirizine HCl 5 mg

  • PURPOSE

    Purpose
    Antihistamine

  • INDICATIONS & USAGE

    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

    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).

  • DOSAGE & ADMINISTRATION

    Directions

    adults and children 6 years and over1 or 2 tablets once daily depending upon severity of symptoms; do not take more than 2 tablets in 24 hours.
    adults 65 years and over1 tablet once a day; do not take more than 1 tablet in 24 hours.
    children under 6 years of ageask a doctor
    consumers with liver or kidney diseaseask a doctor

  • OTHER SAFETY INFORMATION

    Other information

    • store between 20° to 25°C (68° to 77°F).

  • INACTIVE INGREDIENT

    Inactive ingredients corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, titanium dioxide

  • QUESTIONS

    Questions or comments?

    Call 1-877-290-4008

  • PRINCIPAL DISPLAY PANEL

    682R-timely-cetirizine10mg-100ct-label

  • INGREDIENTS AND APPEARANCE
    CETIRIZINE HYDROCHLORIDE 
    cetirizine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49483-682
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POVIDONE K30 (UNII: U725QWY32X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    Product Characteristics
    Colorwhite (White to off white) Scoreno score
    ShapeRECTANGLE (Rounded-off rectangular shaped) Size7mm
    FlavorImprint Code J;219
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49483-682-01100 in 1 BOTTLE; Type 0: Not a Combination Product05/30/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07893305/30/2022
    Labeler - TIME CAP LABORATORIES, INC. (037052099)
    Registrant - TIME CAP LABORATORIES, INC. (037052099)
    Establishment
    NameAddressID/FEIBusiness Operations
    MARKSANS PHARMA LIMITED925822975manufacture(49483-682)
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