Label: CLARITIN CHEWABLE COOL MINT FLAVOR- loratadine tablet, chewable

  • NDC Code(s): 11523-4364-1, 11523-4364-2, 11523-4364-3, 11523-4364-4, view more
    11523-4364-5, 11523-4364-6, 11523-4364-7
  • Packager: Bayer HealthCare LLC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated December 13, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Loratadine

  • PURPOSE

    Purpose

    Antihistamine

  • Uses

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

    • runny nose

    • itchy, watery eyes

    • sneezing

    • itching of the nose or throat

  • WARNINGS

    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

    Directions

    • chew or crush tablets completely before swallowing

    adults and children 6 years and overchew 1 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

    Other information

    • phenylketonurics: contains phenylalanine 3 mg per tablet

    • safety sealed: do not use if the individual blister unit imprinted with Claritin® is open or torn

    • store between 20° to 25°C (68° to 77°F)

  • INACTIVE INGREDIENT

    Inactive ingredients

    anhydrous citric acid;aspartame;fd&c blue no. 1--aluminum lake;magnesium

    stearate;mannitol;menthol;microcrystalline cellulose;silicon dioxide;sodium starch glycolate type a corn;stearic acid

  • Questions or comments

    Questions or comments?

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

  • Carton 8 count

    New Cool Mint

    10 mg Chewable

    Non-Drowsy*

    Claritin®

    Chewables

    loratadine chewable tablets

    10 mg/antihistamine

    24 Hour Relief of:

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

    Indoor & Outdoor

    Allergies

    Cool Mint

    Flavored

    *When taken as directed.

    See Drug Facts Panel.

    8 Chewable Tablets

    Carton label 8 count

  • INGREDIENTS AND APPEARANCE
    CLARITIN CHEWABLE  COOL MINT FLAVOR
    loratadine tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-4364
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    FD&C BLUE NO. 1--ALUMINUM LAKE (UNII: J9EQA3S2JM)  
    MENTHOL (UNII: L7T10EIP3A)  
    ASPARTAME (UNII: Z0H242BBR1)  
    MANNITOL (UNII: 3OWL53L36A)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorblueScoreno score
    ShapeROUNDSize11mm
    FlavorMINTImprint Code CA
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11523-4364-13 in 1 CARTON12/09/2019
    18 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:11523-4364-21 in 1 CARTON12/09/2019
    22 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:11523-4364-31 in 1 CARTON12/09/2019
    34 in 1 BLISTER PACK; Type 0: Not a Combination Product
    4NDC:11523-4364-58 in 1 CARTON12/09/2019
    48 in 1 BLISTER PACK; Type 0: Not a Combination Product
    5NDC:11523-4364-61 in 1 CARTON12/09/2019
    58 in 1 BLISTER PACK; Type 0: Not a Combination Product
    6NDC:11523-4364-71 in 1 POUCH12/09/2019
    62 in 1 BLISTER PACK; Type 0: Not a Combination Product
    7NDC:11523-4364-47 in 1 CARTON12/09/2019
    78 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02189112/09/2019
    Labeler - Bayer HealthCare LLC. (112117283)
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