Label: ALLERY RELIEF 24HR tablet, film coated

  • NDC Code(s): 69168-451-06, 69168-451-60
  • Packager: Allegiant Health
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated April 2, 2024

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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

    • 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 breastfeeding,

    • 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 at room temperature 20°– 25°C (68°– 77°F)
    • do not use if imprinted seal under safety cap is broken or missing
  • Inactive ingredients

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

  • Questions/Comments

    Call 1-888-952-0050 Monday through Friday 9AM - 5PM

  • Principal Display Panel

    Allergy Relief 24HR

    Allergy Relief 24HR

  • INGREDIENTS AND APPEARANCE
    ALLERY RELIEF 24HR 
    allery relief 24hr tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-451
    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
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeOVALSize8mm
    FlavorImprint Code H;LL
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69168-451-06120 in 1 BOTTLE; Type 0: Not a Combination Product04/02/2024
    2NDC:69168-451-6060 in 1 BOTTLE; Type 0: Not a Combination Product04/02/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21351304/02/2024
    Labeler - Allegiant Health (079501930)
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