Label: ALLERGY- loratadine tablet

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 22, 2016

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • 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)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials

More Info on this Drug

Get Label RSS Feed, View NDC Code(s)NEW!