Label: ALLERGY RELIEF- cetirizine hydrochloride tablet

  • NDC Code(s): 21130-712-03, 21130-712-09, 21130-712-12, 21130-712-46, view more
    21130-712-58, 21130-712-81
  • Packager: BETTER LIVING BRANDS, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 2, 2023

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  • Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient (in each tablet)

    Cetirizine HCl 10 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

    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 DOCTOR

    Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.

  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.

  • WHEN USING

    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

    Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding

    • if breast-feeding: Not recommended
    • if pregnant: Ask a health professional before use
  • KEEP OUT OF REACH OF CHILDREN

    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 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 over

    ask a doctor
    children under 6 years of age

    ask a doctor
    consumers with liver or kidney disease

    ask 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?1-877-290-4008

  • PRINCIPAL DISPLAY PANEL

    692R-alb-cetrizine-120ct-label692R-alb-cetrizine-120ct-ifc692R-Alb-Cetirizine-180s-label692R-Alb-Cetirizine-180s-ifc692R-Alb-Cetirizine-14s-ifc692R_Cetirizine Tablets 10mg_45ct_Lbl692R_Cetirizine Tablets 10mg_45ct_IFC692R_Cetirizine Tablets 10mg_30ct_Lbl692R_Cetirizine Tablets 10mg_30ct_IFC

  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF 
    cetirizine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-712
    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
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    Colorwhite (White to off white) Scoreno score
    ShapeRECTANGLE (Rounded-off, rectangular shaped tablet) Size9mm
    FlavorImprint Code J;220
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21130-712-581 in 1 CARTON05/31/2023
    145 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:21130-712-031 in 1 CARTON05/31/2023
    230 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:21130-712-461 in 1 CARTON06/26/2023
    314 in 1 BLISTER PACK; Type 0: Not a Combination Product
    4NDC:21130-712-812 in 1 CARTON06/23/2023
    4NDC:21130-712-0990 in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:21130-712-121 in 1 CARTON08/30/2023
    5120 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07893305/31/2023
    Labeler - BETTER LIVING BRANDS, LLC (009137209)
    Registrant - TIME CAP LABORATORIES, INC. (037052099)
    Establishment
    NameAddressID/FEIBusiness Operations
    MARKSANS PHARMA LIMITED925822975manufacture(21130-712)
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