Label: CETIRIZINE HYDROCHLORIDE (HIVES RELIEF)- cetirizine hydrochloride tablet

  • NDC Code(s): 58602-446-09, 58602-446-17, 58602-446-21, 58602-446-41, view more
    58602-446-47, 58602-447-09, 58602-447-17, 58602-447-21, 58602-447-41, 58602-447-47, 58602-813-04, 58602-813-09, 58602-813-17, 58602-813-23, 58602-813-39, 58602-813-41, 58602-813-83, 58602-813-99
  • Packager: Aurohealth LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 3, 2022

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  • SPL UNCLASSIFIED SECTION


    Drug Facts

  • Active ingredient (in each tablet)


    For 5 mg:

    Cetirizine hydrochloride USP 5 mg

    For 10 mg:

    Cetirizine hydrochloride USP 10 mg

  • Purpose


    Antihistamine

  • Uses


    relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring.

  • Warnings

    Severe Allergy Warning: Get emergency help immediately if you have hives along with any of the following symptoms:


    • trouble swallowing
    • dizziness or loss of consciousness
    • swelling of tongue
    • swelling in or around mouth
    • trouble speaking
    • drooling
    • wheezing or problems breathing

    These symptoms may be signs of anaphylactic shock. This condition can be life threatening if not treated by a health professional immediately. Symptoms of anaphylactic shock may occur when hives first appear or up to a few hours later.

    Not a Substitute for Epinephrine. If your doctor has prescribed an epinephrine injector for "anaphylaxis" or severe allergy symptoms that could occur with your hives, never use this product as a substitute for the epinephrine injector. If you have been prescribed an epinephrine injector, you should carry it with you at all times.


  • Do not use

    • to prevent hives from any known cause such as:
      • foods
      • insect stings
      • medicines
      • latex or rubber gloves

    because this product will not stop hives from occurring. Avoiding the cause of your hives is the only way to prevent them. Hives can sometimes be serious. If you do not know the cause of your hives, see your doctor for a medical exam. Your doctor may be able to help you find a cause.

    • 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.
    • hives that are an unusual color, look bruised or blistered
    • hives that do not itch
  • 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.
    • symptoms do not improve after 3 days of treatment.
    • the hives have lasted more than 6 weeks.
  • 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


    For  5 mg:

    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 over
    		1 tablet once a day; do not take more than 1 tablet in 24 hours.
    children under 6 years of age
    		ask a doctor
    consumers with liver or kidney disease
    		ask a doctor

    For 10 mg:

    adults and children 6 years and over
    		one 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 information

    • store between 20° to 25°C (68° to 77°F)
    • TAMPER EVIDENT: DO NOT USE IF SEAL OVER BOTTLE OPENING IS BROKEN OR MISSING.
  • Inactive ingredients


    colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide

  • Questions?


    call 1-855-274-4122

    Keep the carton. It contains important information.

    Manufactured for:
    AUROHEALTH LLC
    2572 Brunswick Pike
    Lawrenceville, NJ 08648

    Manufactured by:
    Aurobindo Pharma Limited
    Hyderabad-500 072, India

    M.L.No.: 19/HD/AP/95/F/R

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg (30's Tablet Container Carton Label)


    AUROHEALTH
    Original Prescription Strength                 NDC 58602-446-09
    Cetirizine
    Hydrochloride
    Tablets USP 5 mg
    Antihistamine  HIVES Relief

    24 hour                                         
    Relief of Itching                          
    Due to Hives                                

    30
    Tablets
    5 mg each

    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg (30's Tablet Container Carton Label)

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg (10 x 10 Blister Carton Label)

    AUROHEALTH
    NDC 58602-446-21
    Original Prescription Strength 
    Cetirizine
    Hydrochloride
    Tablets USP
    5 mg
    Antihistamine  
    HIVES Relief

    24 hour
    Relief of Itching Due to Hives                          

    100 (10 x 10) Unit-dose Tablets

    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg (10 x 10 Blister Carton Label)

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (30's Tablet Container Carton Label)

    AUROHEALTH
    Original Prescription Strength                 
    NDC 58602-447-09
    Cetirizine
    Hydrochloride
    Tablets USP 10 mg
    Antihistamine
    6 yrs & older
    HIVES Relief
    24 hour
    Relief of itching                             
    Due to Hives

    30
    Tablets
    10 mg each



    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (30's Tablet Container Carton Label)

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (10 x 10 Blister Carton Label)

    AUROHEALTH
    NDC 58602-447-21
    Original Prescription Strength
    Cetirizine
    Hydrochloride
    Tablets USP
    10 mg
    Antihistamine
    6 yrs & older                                
    HIVES Relief

    24 hour
    Relief of Itching Due to Hives              
    100 (10 x 10) Unit-dose Tablets

    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (10 x 10 Blister Carton Label)

  • INGREDIENTS AND APPEARANCE
    CETIRIZINE HYDROCHLORIDE (HIVES RELIEF) 
    cetirizine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-446
    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
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITE (White to Off-white) Scoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code X;35
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58602-446-091 in 1 CARTON08/05/2015
    130 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:58602-446-171 in 1 CARTON08/05/2015
    245 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:58602-446-4775 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product08/05/2015
    4NDC:58602-446-411000 in 1 BOTTLE; Type 0: Not a Combination Product08/05/2015
    5NDC:58602-446-2110 in 1 CARTON08/05/2015
    510 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09076008/05/2015
    CETIRIZINE HYDROCHLORIDE (HIVES RELIEF) 
    cetirizine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-447
    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
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITE (White to Off-white) Scoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code X;36
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58602-447-091 in 1 CARTON08/05/2015
    130 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:58602-447-171 in 1 CARTON08/05/2015
    245 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:58602-447-4775 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product08/05/2015
    4NDC:58602-447-411000 in 1 BOTTLE; Type 0: Not a Combination Product08/05/2015
    5NDC:58602-447-2110 in 1 CARTON08/05/2015
    510 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09076008/05/2015
    CETIRIZINE HYDROCHLORIDE (HIVES RELIEF) 
    cetirizine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-813
    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
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITE (White to Off-white) Score2 pieces
    ShapeRECTANGLE (off-rectangular) Size9mm
    FlavorImprint Code X;2;0
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58602-813-091 in 1 CARTON08/05/2015
    130 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:58602-813-171 in 1 CARTON08/05/2015
    245 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:58602-813-9975 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product08/05/2015
    4NDC:58602-813-231 in 1 CARTON08/05/2015
    4120 in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:58602-813-391 in 1 CARTON08/05/2015
    5365 in 1 BOTTLE; Type 0: Not a Combination Product
    6NDC:58602-813-411000 in 1 BOTTLE; Type 0: Not a Combination Product08/05/2015
    7NDC:58602-813-0410 in 1 CARTON; Type 0: Not a Combination Product08/05/2015
    8NDC:58602-813-8310 in 1 BLISTER PACK; Type 0: Not a Combination Product08/05/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09076008/05/2015
    Labeler - Aurohealth LLC (078728447)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aurobindo Pharma Limited918917642ANALYSIS(58602-446, 58602-447, 58602-813) , MANUFACTURE(58602-446, 58602-447, 58602-813)
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