Label: LEVOCETIRIZINE DIHYDROCHLORIDE tablet, film coated

  • NDC Code(s): 71309-112-18
  • Packager: Safrel Pharmaceuticals LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated February 14, 2023

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  • ACTIVE INGREDIENT(S)

    Levocetirizine dihydrochloride USP 5 mg


  • PURPOSE

    Antihistamine

  • USE(S)

    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 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 right away (1-800-222-1222).

  • DIRECTIONS

                   

     adults 65 years of age and older
          		 
    • ask a doctor
     
     adults and children 12 to 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 
    • ½ tablet (2.5 mg) once daily in the evening may be appropriate for less severe symptoms
     
     children 6 to 11 years of age
          		 
    • 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 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)
    • safety sealed: do not use if carton was opened or if printed foil inner seal on bottle is torn or missing
    • safety sealed: do not use if carton was opened or if individual blister unit is open or torn



  • INACTIVE INGREDIENTS


    colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide.

  • QUESTIONS or COMMENTS?

    call 1-844-384-3723.


    Distributed by:
    Safrel Pharmaceuticals, LLC

    Bridgewater, NJ 08807

    www.safrel.com

  • PRINCIPAL DISPLAY PANEL

    Levocetirizine Dihydrochloride Tablets USP 5 mg-180 Tablets



    Compare to XYZAL ® Allergy 24HR Active Ingredient*

    Allergy Relief

    Levocetirizine Dihydrochloride

    Tablets, USP

    5 mg

    Antihistamine

    24 HOUR Relief of

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

    Original Prescription Strength

    180 TABLETS

    levo

  • INGREDIENTS AND APPEARANCE
    LEVOCETIRIZINE DIHYDROCHLORIDE 
    levocetirizine dihydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71309-112
    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
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    Product Characteristics
    Colorwhite (White to off white) Score2 pieces
    ShapeOVALSize8mm
    FlavorImprint Code H;LL
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71309-112-18180 in 1 BOTTLE; Type 0: Not a Combination Product10/28/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21351310/28/2022
    Labeler - Safrel Pharmaceuticals LLC (080566287)
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