Label: ALLERGY- loratadine tablet

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

Drug Label Information

Updated December 22, 2016

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  • Active ingredient

    Loratadine 10mg

  • Purpose

    Antihistamine

  • Uses

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

    ■ sneezing

    ■ runny nose

    ■ itchy, watery eyes

    ■ 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

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

    Pregnancy/Breastfeeding

     If pregnant or breast-feeding, ask a health professional before use. 

    Keep out of reach of children

    Keep out of reach of children. In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) immediately.

  • 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 packaging is torn or open

  • Inactive ingredients

    croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, silicon dioxide

  • Questions or comments?

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

  • Principal Display Panel

    XL-3 Allergy Relief

    XL-3 Allergy Relief

     

  • INGREDIENTS AND APPEARANCE
    ALLERGY 
    loratadine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63654-309
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeOVALSize6mm
    FlavorImprint Code LOR;10;APO
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63654-309-101 in 1 CARTON12/16/2014
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07647112/16/2014
    Labeler - Selder, S.A. de C.V. (824413629)
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