Label: CETIRIZINE HYDROCHLORIDE (ALLERGY)- cetirizine hydrochloride capsule

  • NDC Code(s): 21130-099-97
  • Packager: Better Living Brands, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 22, 2023

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

View All Sections
  • SPL UNCLASSIFIED SECTION

    Cetirizine HCl Capsules 10 mg (Allergy)
    Drug Facts

  • Active ingredient (in each capsule)

    Cetirizine HCI USP 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 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 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 over
    		one 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 over
    		ask a doctor
    children under 6 years of age
    		ask a doctor
    consumers with liver or
    kidney disease
    		ask a doctor


  • Other information

    • store at 20°-25°C (68°-77°F)
    • avoid high humidity and excessive heat above 40°C (104°F)
    • protect from light
    • do not use if seal imprinted with SEALED for YOUR PROTECTION under the bottle cap is broken or missing.

  • Inactive ingredients

    black iron oxide, gelatin, glycerin, hypromellose, polyethylene glycol, propylene glycol, purified water, sodium hydroxide, sorbitol sorbitan solution

  • Questions or comments?

    call 1-855-274-4122 (Monday - Friday 8:30 AM to 5:00 PM EST)


    DISTRIBUTED BY:
    BETTER LIVING BRANDS LLC
    P.O.BOX 99, PLEASANTON
    CA 94566-0009
    ‡1-888-723-3929


    Made in India 
    Code: TS/DRUGS/22/2009

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (25's Capsule Container Label)

    NDC 21130-099-97

    Signature
    care®
    Quality
    Guaranteed

    Original Prescription Strength
    Allergy

    CETIRIZINE HCl capsules 10 mg
    Antihistamine

    Indoor + Outdoor Allergies

    25 Liquid Gels**
    **liquid-filled capsules

    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (25's Capsule Container Label)

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -10 mg (25's Capsule Container Carton Label)

    Signature
    care®
    Quality
    Guaranteed

    COMPARE TO Zyrtec®
    Active Ingredient*

    NDC 21130-099-97
    Original Prescription Strength
    Allergy

    CETIRIZINE HCl capsules    10 mg
    Antihistamine

    Indoor + Outdoor Allergies
    24 Hour Relief of:

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

    Actual Size

    25 LIQUID GELS**
    **liquid-filled capsules


    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -10 mg (25's Capsule Container Carton Label)

  • INGREDIENTS AND APPEARANCE
    CETIRIZINE HYDROCHLORIDE (ALLERGY) 
    cetirizine hydrochloride capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-099
    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
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorYELLOW (Clear colourless to pale yellow viscous liquid) Scoreno score
    ShapeOVALSize13mm
    FlavorImprint Code CZ10
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21130-099-971 in 1 CARTON11/15/2023
    125 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20910711/15/2023
    Labeler - Better Living Brands, LLC (009137209)
    Registrant - Aurohealth LLC (078728447)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aurobindo Pharma Limited650381903ANALYSIS(21130-099) , MANUFACTURE(21130-099)
    Establishment
    NameAddressID/FEIBusiness Operations
    APL HEALTHCARE LIMITED650844777ANALYSIS(21130-099) , MANUFACTURE(21130-099)
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!