Label: CETIRIZINE HYDROCHLORIDE tablet

  • NDC Code(s): 70985-001-01, 70985-001-02
  • Packager: Drug Ocean LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 23, 2023

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  • Active Ingredients

    Active Ingredient (in each tablet)                                                        Purpose
    Cetirizine HCl USP 5 mg.....................................................................................Antihistimine

  • 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

    • drowsines may occur
    • avoid alcoholic drinks
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • be careful when driving a motor vehicle or operating machinary.
  • STOP USE

    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 Poison Control Center right away. (1-800-222-1222)

  • Directions

    Adults and children 6
     years and over
    		1 to 2 tablets once daily depending upon severity of symptoms; do not take more than 2 tablets in 24 hours.
    Adults 65 years and over1 tablet1 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 Information

    Store between 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature.]

  • Inactive Ingredients

    hypromellose, lactose, magnesium stearate, maize starch, polyethylene glycol, povidone, titanium dioxide.

  • Questions?

    Call 1-866-562-4597

  • SPL UNCLASSIFIED SECTION

    Manufactured for:

    Drug Ocean, LLC
    1 Bridge Plaza, North Central Road,

    6th Floor, Suite 675,

    Fort Lee, NJ 07024

    Manufactured by:

    Unique Pharmaceutical Laboratories
    (A Div. of J. B. Chemicals &Pharmaceuticals Ltd.),
    Mumbai 400 030, India

    M.L. G/1430

    Rev. 12/2023

  • Cetirizine Hydrochloride Tablets 5 mg Container Label

    DRUG OCEAN NDC 70985-001-01

    Original Prescription Strength

    Cetirizine Hydrochloride

    Tablets USP

    5 mg

    100 Tablets

    100 tablets

    DRUG OCEAN NDC 70985-001-02

    Original Prescription Strength

    Cetirizine Hydrochloride

    Tablets USP

    5 mg

    500 Tablets

    500 tablets

  • INGREDIENTS AND APPEARANCE
    CETIRIZINE HYDROCHLORIDE 
    cetirizine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70985-001
    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
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colorwhite (White) Scoreno score
    ShapeBULLET (Barrel Shaped) Size7mm
    FlavorImprint Code CTN;5
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70985-001-01100 in 1 BOTTLE; Type 0: Not a Combination Product11/08/2016
    2NDC:70985-001-02500 in 1 BOTTLE; Type 0: Not a Combination Product11/08/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07782911/08/2016
    Labeler - Drug Ocean LLC (080381835)
    Registrant - Unique Pharmaceutical Laboratories (917165052)
    Establishment
    NameAddressID/FEIBusiness Operations
    Unique Pharmaceutical Laboratories650434645manufacture(70985-001)
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