Label: XL - 3 ALLERGY tablet

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

Drug Label Information

Updated April 10, 2024

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  • Active ingredient(s)

    Loratadine 10mg

  • Purpose

     Antihistamine

  • Use(s)

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

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

    Do not use

    if you have ever had an allergic reaction to this product or any of its ingredients

    Ask a doctor before use if

    you have liver or kidney disease. Your doctor should determine if you need a different dose.

    When using this product

    do not take more than directed. Taking more than directed may cause drowsiness.

    Stop use and ask a doctor if

    if an allergic reaction to this product occurs. Seek medical help right away.

    If pregnant or breastfeeding,

    ask a health professional before use.

    Keep out of reach of children

    In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) right away.

  • Directions

    Adults and children 6 years and over: 1 tablet daily; not more than 1 tablet in 24 hours

    Children under 6 years of age: ask a doctor

    Consumers with liver or kidney disease: ask a doctor

  • Other information

    • store between 20° to 25°C (68° to 77°F)
    • protect from excessive moisture
    • do not use if blister unit is torn or open
  • Inactive ingredients

    lactose monohydrate, magnesium stearate, pregelatinized starch, sodium starch glycolate

  • Questions/Comments

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

  • Principal Display Panel

    XL - 3 Allergy

    XL - 3 Allergy

  • INGREDIENTS AND APPEARANCE
    XL - 3 ALLERGY 
    xl - 3 allergy tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63654-415
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code G;10
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63654-415-101 in 1 CARTON04/10/2024
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21072204/10/2024
    Labeler - Selder, S.A. de C.V. (824413629)
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