Label: CETIRIZINE HYDROCHLORIDE capsule, liquid filled

  • NDC Code(s): 59556-894-12, 59556-894-77, 59556-894-78, 59556-894-79
  • Packager: Strides Pharma, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated August 24, 2026

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  • Active ingredient (in each capsule)

    Cetirizine HCl 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 useif 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 haveliver or kidney disease. Your doctor should determine if you need a different dose.

    Ask a doctor or pharmacist before use if you aretaking 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
    • in rare cases, you may experience itching after stopping cetirizine. Consult your healthcare provider if this happens.

    Stop use and ask a doctor ifan 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

    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 overask a doctor
    children under 6 years of ageask a doctor
    consumers with liver or kidney diseaseask 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 Tamper-Evident seal under cap imprinted with "Sealed for your Protection" is broken or missing.
  • Inactive ingredients

    gelatin, medium chain triglyceride, polyethylene glycol 400, printing ink white (isopropyl alcohol, propylene glycol, shellac resins, sodium lauryl sulphate, titanium dioxide) purified water, sodium hydroxide, sorbitol-sorbitan solution.

  • QUESTIONS

    Questions or comments?

    call 1-877-244-9825

    Distributed by:
    Strides Pharma, Inc
    Bridgewater, NJ 08807.


    Revised: 08/2026

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Cetirizine HCL
    Capsules, 10mg
    Antihistamine Allergy
    -Original Prescription Strength
    -24 Hour Relief of
    Runny nose
    Sneezing
    Itchy, watery eyes
    Itching of the nose or throat
    -INDOOR & OUTDOOR ALLERGIES

    12 Liquid Filled Capsules -Carton Label

    carton-12s

    12 Liquid Filled Capsules -Container Label

    container-12s-part-1-top

    container-12s-part-1-back

    container-12s-part-2-top

    container-12s-part-2-back

    container-12s-base-label

    25 Liquid Filled Capsules -Carton Label

    carton-25s

    25 Liquid Filled Capsules -Container Label

    container-25s-part-1-top

    container-25s-part-1-back

    container-25s-part-2-top

    container-25s-part-2-back

    container-25s-base-label

    40 Liquid Filled Capsules -Carton Label

    carton-40s

    40 Liquid Filled Capsules -Container Label

    container-40s-top

    container-40s-base-label

    7000 Liquid Filled Capsules -Carton Label (Transit Pack)

    carton-7000s-bulk-label

  • INGREDIENTS AND APPEARANCE
    CETIRIZINE HYDROCHLORIDE 
    cetirizine hydrochloride capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59556-894
    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
    GELATIN (UNII: 2G86QN327L)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHELLAC (UNII: 46N107B71O)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SORBITAN (UNII: 6O92ICV9RU)  
    SORBITOL (UNII: 506T60A25R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Coloryellow (colorless to pale yellow) Scoreno score
    ShapeOVALSize14mm
    FlavorImprint Code 291
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59556-894-121 in 1 CARTON07/21/2017
    140 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:59556-894-771 in 1 CARTON07/21/2017
    212 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:59556-894-797000 in 1 BAG; Type 0: Not a Combination Product07/21/2017
    4NDC:59556-894-781 in 1 CARTON07/21/2017
    425 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20529107/21/2017
    Labeler - Strides Pharma, Inc. (078868278)
    Registrant - Onesource Softgels Pte. Ltd. (599465138)
    Establishment
    NameAddressID/FEIBusiness Operations
    Strides Pharma Science Limited918513263analysis(59556-894) , manufacture(59556-894) , pack(59556-894)
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