Label: CLARITIN CHEWABLE GRAPE AND BUBBLEGUM- loratadine kit

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated August 17, 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 ●itchy, watery eyes ●sneezing ●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

    • chew or crush tablets completely before swallowing.
    adults and children 6 years and overchew 2 tablets daily; not more than 2 chewable tablets in 24 hours
    children 2 to under 6 years of agechew 1 tablet daily; not more than 1 chewable tablet in 24 hours
    children under 2 years of ageask a doctor
    consumers with liver or kidney diseaseask a doctor

  • Other Information

    phenylketonurics:

    • grape flavor contains phenylalanine 1.4 mg per chewable tablet
    • bubblegum flavor contains phenylalanine 1.9 mg per chewable 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

    Grape chewable tablets

    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 aicd

    Bubblegum chewable tablets

    aspartame, carmine, citric acid, colloidal silicon dioxide, flavor, magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate, stearic acid

  • Questions or comments?

    1-800-CLARITIN (1-800-252-7484)

  • PRINCIPAL DISPLAY PANEL - 40 Chewable Tablet Blister Pack Carton

    VARIETY PACK

    ages
    2 +

    years

    Non-Drowsy*

    Children's
    Claritin ®

    Chewables

    loratadine chewable tablets

    5 mg/antihistamine


    24 Hour

    Non-Drowsy* Relief of:

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

    Indoor & Outdoor Allergies

    20 Grape Flavored

    20 Bubblegum Flavored

    *When taken as directed. See Drug Facts Panel.

    40 CHEWABLE TABLETS

    Childrens Chewables 5mg

  • INGREDIENTS AND APPEARANCE
    CLARITIN CHEWABLE GRAPE AND BUBBLEGUM 
    loratadine kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-0123
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11523-0123-11 in 1 CARTON; Type 0: Not a Combination Product09/01/2023
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 1 20 
    Part 2 20 
    Part 1 of 2
    CLARITIN 
    loratadine tablet, chewable
    Product Information
    Item Code (Source)NDC:11523-4330
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    ASPARTAME (UNII: Z0H242BBR1)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    CARMINIC ACID (UNII: CID8Z8N95N)  
    MANNITOL (UNII: 3OWL53L36A)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    Colorpink (light to medium pink with a slightly and/or mottled appearance) Scoreno score
    ShapeROUND (round (flat faced beveled edge)) Size10mm
    FlavorBUBBLE GUMImprint Code C
    Contains    
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02189109/15/2015
    Part 2 of 2
    CLARITIN 
    loratadine tablet, chewable
    Product Information
    Item 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
    ASPARTAME (UNII: Z0H242BBR1)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    MANNITOL (UNII: 3OWL53L36A)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    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    
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02189108/23/2006
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02189108/23/2006
    Labeler - Bayer HealthCare LLC. (112117283)
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