Label: CURIST ALLERGY RELIEF- levocetirizine dihydrochloride tablet

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

Drug Label Information

Updated October 15, 2019

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

  • SPL UNCLASSIFIED SECTION

    Read directions and warnings before use. Keep carton as it contains important information.

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient (in each tablet)

    Levocetirizine dihydrochloride USP 5 mg

  • PURPOSE

    Purpose

    Antihistamine

  • INDICATIONS & USAGE

    Uses

    temporarily relieves these symptoms due to hay fever or other respiratory allergies:

    • runny nose
    • sneezing
    • itchy, watery eyes
    • itching of the nose or throat
  • WARNINGS

    Warnings

    Do not use

    • if you have kidney disease
    • if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing cetirizine

    Ask a doctor before use if you have ever had trouble urinating or emptying your bladder.

    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

    • you have trouble urinating or emptying your bladder
    • 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.

  • DOSAGE & ADMINISTRATION

    Directions

    adults 65 years and older

    ask a doctor

    adults and children 12-64 years
    • take 1 tablet (5 mg) once daily in the evening
    • do not take more than 1 tablet (5 mg) in 24 hours
    • ½ tablet (2.5 mg) once daily in the evening may be appropriate for less severe symptoms
    children 6-11 years
    • take ½ tablet (2.5 mg) once daily in the evening
    • do not take more than ½ tablet (2.5 mg) in 24 hours
    children under 6 yearsdo not use
    consumers with kidney diseasedo not use
  • STORAGE AND HANDLING

    Other information

    • ​store between 20° and 25°C (68° and 77°F)
    • safety sealed: do not use if carton was opened or torn

  • INACTIVE INGREDIENT

    Inactive ingredients hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, silicon dioxide, titanium dioxide

  • QUESTIONS

    Questions? call 1-855-243-1241

  • SPL UNCLASSIFIED SECTION

    Distributed by:

    Little Pharma, Inc. New York, NY 10023

    Made in India

  • PRINCIPAL DISPLAY PANEL

    curist

    Allergy Relief

    Levocetirizine Dihydrochloride Tablets, USP 5 mg

    Antihistamine

    24 Hour Relief of Runny Nose; Sneezing; Itchy, Watery Eyes; Itchy Nose or Throat

    90 Tablets

    Curist Levocetirizine Dihydrochloride Box-10-OL

  • INGREDIENTS AND APPEARANCE
    CURIST ALLERGY RELIEF 
    levocetirizine dihydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72559-007
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LEVOCETIRIZINE DIHYDROCHLORIDE (UNII: SOD6A38AGA) (LEVOCETIRIZINE - UNII:6U5EA9RT2O) LEVOCETIRIZINE DIHYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeOVALSize8mm
    FlavorImprint Code LI
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72559-007-051 in 1 CARTON10/15/2019
    190 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21155110/15/2019
    Labeler - Little Pharma, Inc. (074328189)