Label: CLARITIN- loratadine tablet, chewable

  • NDC Code(s): 11523-4328-1, 11523-4328-2, 11523-4328-3, 11523-4328-4, view more
    11523-4328-5, 11523-4328-6, 11523-4328-7, 11523-4328-9, 11523-4331-1, 11523-4331-2, 11523-4331-6
  • Packager: Bayer HealthCare LLC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated June 28, 2023

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  • Active ingredient (in each tablet)

    Loratadine 5 mg

  • 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 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.

  • Directions

    adults and children 6 years and overchew 2 tablets daily; not more than 2 tablets in 24 hours
    children 2 to under 6 years of agechew 1 tablet daily; not more than 1 tablet in 24 hours
    children under 2 years of ageask a doctor
    consumers with liver or kidney diseaseask a doctor
  • Other information

    • phenylketonurics: contains phenylalanine 1.4 mg per tablet
    • safety sealed: do not use if the individual blister unit imprinted with Children's Claritin® is open or torn
    • store between 20° to 25°C (68° to 77°F)
  • Inactive ingredients

    aspartame, citric acid anhydrous, colloidal silicon dioxide, D&C red No. 27 aluminum lake, FD&C blue No. 2 aluminum lake, flavor, magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate, stearic acid

  • Questions or comments?

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

  • SPL UNCLASSIFIED SECTION

    Dist by: Bayer HealthCare LLC, Whippany, NJ 07981

    Product of Ireland

  • PRINCIPAL DISPLAY PANEL - 10 Chewable Tablet Blister Pack Carton

    NDC 11523-4328-1

    ages

    2 years

    and older

    Children's

    Claritin®

    Allergy

    loratadine 5 mg/antihistamine

    Indoor & Outdoor

    Allergies

    Non-Drowsy*

    24 Hour Relief of:

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

    10 CHEWABLE TABLETS

    Grape

    Flavored

    Chewables

    *When taken as directed. See Drug Facts Panel.

    Carton

    Carton 2

  • INGREDIENTS AND APPEARANCE
    CLARITIN 
    loratadine tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-4328
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    ASPARTAME (UNII: Z0H242BBR1)  
    Product Characteristics
    Colorpurple (light to medium purple with a slightly speckled and/or mottled appearance) Scoreno score
    ShapeROUND (flat faced beveled edge) Size10mm
    FlavorGRAPEImprint Code C
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11523-4328-11 in 1 CARTON08/23/2006
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:11523-4328-22 in 1 CARTON08/23/2006
    210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:11523-4328-33 in 1 CARTON08/23/2006
    310 in 1 BLISTER PACK; Type 0: Not a Combination Product
    4NDC:11523-4328-55 in 1 CARTON08/23/2006
    410 in 1 BLISTER PACK; Type 0: Not a Combination Product
    5NDC:11523-4328-41 in 1 POUCH08/23/2006
    52 in 1 BLISTER PACK; Type 0: Not a Combination Product
    6NDC:11523-4328-72.5 in 1 PACKAGE, COMBINATION08/23/2006
    610 in 1 BLISTER PACK; Type 0: Not a Combination Product
    7NDC:11523-4328-94 in 1 CARTON08/23/2006
    710 in 1 BLISTER PACK; Type 0: Not a Combination Product
    8NDC:11523-4328-650 in 1 BOX08/23/2006
    82 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02189108/23/2006
    CLARITIN 
    loratadine tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-4331
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MANNITOL (UNII: 3OWL53L36A)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    ASPARTAME (UNII: Z0H242BBR1)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    Product Characteristics
    Colorpurple (Light to medium purple with a slightly speckled and/or mottled appearance) Scoreno score
    ShapeROUND (Flat Faced Beveled Edge) Size10mm
    FlavorGRAPEImprint Code C
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11523-4331-14 in 1 CARTON08/23/2006
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:11523-4331-26 in 1 CARTON09/06/2019
    210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:11523-4331-68 in 1 CARTON08/23/2006
    310 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02189108/23/2006
    Labeler - Bayer HealthCare LLC. (112117283)
    Establishment
    NameAddressID/FEIBusiness Operations
    Patheon Manufacturing Services LLC079415560manufacture(11523-4328)
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