Label: CLARITIN- loratadine tablet

  • NDC Code(s): 11523-0007-1, 11523-0007-2, 11523-0007-3, 11523-0007-4, view more
    11523-0007-5, 11523-0007-7, 11523-0007-8, 11523-0007-9
  • Packager: Bayer HealthCare LLC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated March 24, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • SPL UNCLASSIFIED SECTION

  • ACTIVE INGREDIENT

    Active ingredient (in each tablet)

    Loratadine, 10 mg USP

  • PURPOSE

    Purpose

    Antihistamine

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

    Ask a doctor

    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

    When using this product do not take more than directed. Taking more than directed may cause drowsiness.

    Stop use

    Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

    If pregnant or breast-feeding

    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 overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

  • Directions

    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 diseaseask a doctor

  • 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

  • Carton label 10 count tablets

    Original Prescription Strength

    Non-Drowsy*

    Claritin®

    loratadine tablets 10 mg/antihistamine

    Indoor & Outdoor

    Allergies

    24

    Hour

    Relief of:

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

    *When taken as directed.

    See Drug Facts Panel

    Carton label 10 count

  • INGREDIENTS AND APPEARANCE
    CLARITIN 
    loratadine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-0007
    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)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code Claritin;10;458
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11523-0007-11 in 1 CARTON12/01/2020
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:11523-0007-22 in 1 CARTON12/01/2020
    210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:11523-0007-330 in 1 BOTTLE; Type 0: Not a Combination Product12/01/2020
    4NDC:11523-0007-785 in 1 BOTTLE; Type 0: Not a Combination Product12/01/2020
    5NDC:11523-0007-440 in 1 BOTTLE; Type 0: Not a Combination Product12/01/2020
    6NDC:11523-0007-545 in 1 BOTTLE; Type 0: Not a Combination Product12/01/2020
    7NDC:11523-0007-82 in 1 CARTON07/30/2021
    7115 in 1 BOTTLE; Type 0: Not a Combination Product
    8NDC:11523-0007-960 in 1 BOTTLE; Type 0: Not a Combination Product03/16/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07520912/01/2020
    Labeler - Bayer HealthCare LLC. (112117283)
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