Label: ALLERGY RELIEF- cetirizine hcl tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated April 16, 2021

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

  • Active ingredient (in each tablet)

    Cetirizine HCl 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 a doctor before use if you have

    liver or kidney disease. Your doctor should determine if you need a different dose.

    Ask a doctor or pharmacist before use if you are

    taking tranquilizers or sedatives.

    When using this product

    • drowsiness may occur
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • avoid alcoholic drinks
    • 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 (1-800-222-1222) right away.

  • Directions

    adults and children 6 years and over Take 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 20º to 25ºC (68º to 77ºF)
    • contains no ingredient made from a gluten-containing grain(wheat, barley or rye)
  • Inactive ingredients

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

  • Questions or comments?

    Call 1-888-588-1418 Monday-Friday 9AM-5PM EST

  • Principal Display Panel

    *Compare to the active ingredient in Zyrtec®

    Allergy Relief

    Cetirizine HCl Tablets USP, 10 mg/Antihistamine

    Indoor & Outdoor Allergies

    24 hour relief of

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

    Original Prescription Strength

    Tablets

    *This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Zyrtec®.

    TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

    Distributed by:

    Camber Consumer Care Inc, Piscataway, NJ 08854, USA

  • HOW SUPPLIED

    Product: 50090-3906

    NDC: 50090-3906-1 30 TABLET in a BOTTLE

    NDC: 50090-3906-2 100 TABLET in a BOTTLE

    NDC: 50090-3906-3 90 TABLET in a BOTTLE

    NDC: 50090-3906-0 14 TABLET in a BOTTLE

  • Cetirizine HCl

    Label Image
  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF 
    cetirizine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50090-3906(NDC:69230-304)
    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
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorWHITEScore2 pieces
    ShapeOVALSize9mm
    FlavorImprint Code G;4
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50090-3906-130 in 1 BOTTLE; Type 0: Not a Combination Product12/31/2018
    2NDC:50090-3906-2100 in 1 BOTTLE; Type 0: Not a Combination Product12/31/2018
    3NDC:50090-3906-390 in 1 BOTTLE; Type 0: Not a Combination Product12/31/2018
    4NDC:50090-3906-014 in 1 BOTTLE; Type 0: Not a Combination Product12/31/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20927412/31/2018
    Labeler - A-S Medication Solutions (830016429)
    Establishment
    NameAddressID/FEIBusiness Operations
    A-S Medication Solutions830016429RELABEL(50090-3906) , REPACK(50090-3906)