Label: CLARITIN- loratadine tablet tablet

  • NDC Code(s): 66715-9742-1, 66715-9742-2
  • Packager: Lil' Drug Store Products, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 28, 2022

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  • Drug Facts

    Drug Facts

  • Active Ingredient

    ​Active Ingredient (in each tablet)

    Loratadine, USP 10 mg

  • Purpose

    ​Purpose

    Antihistamine

  • Uses

    Uses

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

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

    Do not use

    ​Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

    Ask a doctor before use

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

    If pregnant or breast-feeding, 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).

  • DOSAGE & ADMINISTRATION

    Directions

    adults and children 6 years and over1 tablet daily; not more than 1 tablet in 24 hours
    children under 6 years of ageask a doctor

    consumers with liver or kidney disease

    		ask a doctor

  • SPL UNCLASSIFIED SECTION

    Other information

    • store at 20º -25º C (68º -77º F) (see USP Controlled Room Temperature)
  • INACTIVE INGREDIENT

    Inactive ingredients

    lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

  • QUESTIONS

    Questions or comments?

    1-800-CLARITIN (1-800-252-7484) or www.claritin.com

  • PRINCIPAL DISPLAY PANEL

    Original Prescription Strength

    Non-Drowsy* ®

    Claritin ®

    loratadine tablets 10 mg/antihistamine

    24

    Hour

    Relief of:

    • Sneezing
    • Runny Nose
    • Itchy,

    Watery Eyes

    • Itchy Throat

    or nose

    Indoor & Outdoor

    Allergies

    [Bayer cross] *When takenas directed.

    See Drug Facts Panel.

    1

    Tablet [tablet image] [Lil' Drug Store logo]

    PDP/Package

  • INGREDIENTS AND APPEARANCE
    CLARITIN 
    loratadine tablet tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66715-9742
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code CLARITIN10;458
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66715-9742-11 in 1 CARTON06/01/2022
    11 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:66715-9742-22 in 1 CARTON06/01/2022
    21 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07520906/01/2022
    Labeler - Lil' Drug Store Products, Inc. (093103646)
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