Label: ALLERGY RELIEF- levocetirizine dihydrochloride tablet, film coated

  • NDC Code(s): 41250-488-01, 41250-488-27
  • Packager: Meijer Distribution Inc
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated March 9, 2020

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  • Active ingredient (in each tablet)

    Levocetirizine dihydrochloride 5 mg

  • Purpose

    Antihistamine

  • Uses

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

    •
    runny nose
    •
    itchy, watery eyes
    •
    sneezing
    •
    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 12-64 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 6-11 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)
    •
    do not use if printed foil under cap is broken or missing
  • Inactive ingredients

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

  • Questions or comments?

    1-800-719-9260

  • Package/Label Principal Display Panel

    Compare to XYZAL® Allergy 24HR active ingredient

    ORIGINAL PRESCRIPTION STRENGTH

    allergy relief

    Levocetirizine

    Dihydrochloride Tablets, 5 mg

    Antihistamine

    24 HOUR RELIEF OF:

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

    35 Tablets

    actual size

    2416E-allergy-relief.jpg
  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF 
    levocetirizine dihydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41250-488
    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
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITEScore2 pieces
    ShapeOVALSize8mm
    FlavorImprint Code L9CZ;5
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41250-488-011 in 1 CARTON02/08/2020
    135 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:41250-488-271 in 1 CARTON02/06/2020
    280 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21198302/06/2020
    Labeler - Meijer Distribution Inc (006959555)
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