Label: APTRIZINE 24-HOUR ALL DAY ALLERGY- cetirizine hydrochloride tablet

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

Drug Label Information

Updated February 21, 2013

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  • active ingredient

    CETIRIZINE HYDROCHLORIDE
  • Purpose

    Antihistamine
  • 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.
  • Indications and Usage

    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.
  • Warning

    If you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.
  • Dosage and Administration

    Adults and children 6years andover 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 65years and over: ask a doctor.

    Children under 4-6 years of age: ask a doctor
     
    Children under 4 years of age: ask a doctor

    Consumers with liver or kidney disease: ask a doctor
  • Inactive Ingredient

    LACTOSE MONOHYDRATE
  • Inactive Ingredient

    STARCH, CORN

  • Inactive Ingredient

    GELATIN
  • Inactive Ingredient

    METHYLPARABEN
  • Inactive Ingredient

    TITANIUM DIOXIDE
  • Inactive Ingredient

    MAGNESIUM STEARATE
  • Inactive Ingredient

    TALC
  • Inactive Ingredient

    SODIUM STARCH GLYCOLATE TYPE A POTATO
  • DISPLAY PANEL

    product
  • INGREDIENTS AND APPEARANCE
    APTRIZINE  24-HOUR ALL DAY ALLERGY
    cetirizine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46084-012
    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) 21.66 mg
    STARCH, CORN (UNII: O8232NY3SJ) 85.32 mg
    GELATIN (UNII: 2G86QN327L) 2.4 mg
    METHYLPARABEN (UNII: A2I8C7HI9T) .2 mg
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) .1 mg
    MAGNESIUM STEARATE (UNII: 70097M6I30) 1.3 mg
    TALC (UNII: 7SEV7J4R1U) 3.9 mg
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) 3.9 mg
    Product Characteristics
    Colorwhite (white) Scoreno score
    ShapeROUND (no score) Size7mm
    FlavorImprint Code 10mg
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:46084-012-15120 in 1 BLISTER PACK
    2NDC:46084-012-1460 in 1 BLISTER PACK
    3NDC:46084-012-1345 in 1 BLISTER PACK
    4NDC:46084-012-1230 in 1 BLISTER PACK
    5NDC:46084-012-1115 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA01983502/21/2013
    Labeler - A P J Laboratories Limited (677378339)
    Registrant - A P J Laboratories Limited (677378339)
    Establishment
    NameAddressID/FEIBusiness Operations
    A P J Laboratories Limited677378339manufacture(46084-012)
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