Label: LEVOCETIRIZINE DIHYDROCHLORIDE tablet, coated

  • NDC Code(s): 43598-669-22, 43598-669-35, 43598-669-80, 43598-735-22, view more
    43598-735-35, 43598-735-79, 43598-735-80
  • Packager: Dr. Reddy's Laboratories Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated September 5, 2019

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

  • Active ingredient (in each tablet)

    Levocetirizine dihydrochloride USP, 5 mg

  • Purpose

    Antihistamine

  • 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

    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 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-feding: 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

    adults 65 years of age and older
    • ask a doctor
    adults and children 12-64 years of age
    • take 1 tablet (5 mg) once daily in the evening
    • do not take more than 1 tablet (5 mg) in 24 hours
    • 1/2 tablet (2.5 mg) once daily in the evening may be appropriate for less severe symptoms
    children 6-11 years of age
    • take 1/2 tablet (2.5 mg) once daily in the evening
    • do not take more than 1/2 tablet (2.5 mg) in 24 hours
    children under 6 years of age
    • do not use
    consumers with kidney disease
    • do not use

  • Other information

    • store between 20° and 25°C (68° and 77°F)
    • (bottles only) safety sealed: do not use if carton was opened or if printed foil inner seal on bottle is torn or missing
    • (blister only) safety sealed: do not use if seal is broken or if individual blister unit is open or torn

  • Inactive ingredients

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

  • Questions or comments?

    Call 1-888-375-3784

  • Levocetirizine Dihydrochloride Tablets, USP 5 mg carton label

    Dr. Reddy's
    NDC 43598-735-35

    Original Prescription Strength

    Levocetirizine
    Dihydrochloride
    Tablets USP, 5 mg

    Antihistamine

    ALLERGY

    24 HOUR

    Relief of:

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

    35 Tablets

    carton735


  • Levocetirizine Dihydrochloride Tablets USP, 5 mg bottle label

    NDC 43598-735-35
    Dr.Reddy's

    Original Prescription Strength
    Levocetirizine
    Dihydrochloride Tablets USP, 5 mg
    Antihistamine

    ALLERGY

    24 HOUR

    35 Tablets

    bottle735

  • INGREDIENTS AND APPEARANCE
    LEVOCETIRIZINE DIHYDROCHLORIDE 
    levocetirizine dihydrochloride tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43598-669
    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
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Polyethylene Glycol, Unspecified (UNII: 3WJQ0SDW1A)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeOVALSize9mm
    FlavorImprint Code L;L
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43598-669-351 in 1 CARTON03/12/201809/06/2019
    135 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:43598-669-221 in 1 CARTON03/12/201809/06/2019
    255 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:43598-669-801 in 1 CARTON03/12/201809/06/2019
    380 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21037503/12/201809/06/2019
    LEVOCETIRIZINE DIHYDROCHLORIDE 
    levocetirizine dihydrochloride tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43598-735
    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
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Polyethylene Glycol, Unspecified (UNII: 3WJQ0SDW1A)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeOVALSize9mm
    FlavorImprint Code L
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43598-735-351 in 1 CARTON03/12/2018
    135 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:43598-735-221 in 1 CARTON03/12/2018
    255 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:43598-735-801 in 1 CARTON03/12/2018
    380 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:43598-735-792 in 1 CARTON04/17/2018
    45 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21037503/12/2018
    Labeler - Dr. Reddy's Laboratories Inc. (802315887)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dr.Reddy's Laboratories Limited-FTO 3918608162analysis(43598-669, 43598-735) , manufacture(43598-669, 43598-735)
    Establishment
    NameAddressID/FEIBusiness Operations
    Reed-Lane, Inc.001819879pack(43598-669, 43598-735)