Label: CLARITIN- loratadine tablet, chewable

  • NDC Code(s): 11523-4330-1, 11523-4330-3, 11523-4330-4
  • Packager: Bayer HealthCare LLC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated February 17, 2021

If you are a consumer or patient please visit this version.

  • Drug Facts

  • Active Ingredients

    Loratadine 5 mg

  • Purpose

    Antihistamine

  • INDICATIONS & USAGE

    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
  • Do Not Use

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

  • AS a doctor before use if you have

    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 and ask a doctor if

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

  • PREGNANCY 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.

  • Directions

    adults and children 6 years and over

    chew 2 tablets daily; not more than 2 tablets in 24 hours

    children 2 to under 6 years of age

    chew 1 tablet daily; not more than 1 tablet in 24 hours
    children under 2 years of age

    ask a doctor

    consumers with liver or kidney disease

    ask a doctor

  • Other information

    • phenylketonurics: contains phenylalanine 1.9 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 INGREDIENT

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

  • QUESTIONS

    1-800-CLARITIN

  • WARNINGS

  • PRINCIPAL DISPLAY PANEL

    ages

    2 years®

    and older

    Children's

    Claritin®

    Chewables

    loratadine 5 mg/antihistamine

    Indoor & Outdoor

    Allergies

    *When taken as directed.

    See Drug Facts Panel

    Non-Drowsy*

    24 Hour Relief of:

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

    Bubblegum

    Flavored

    10

    Chewable Tablets

    10-count carton

  • INGREDIENTS AND APPEARANCE
    CLARITIN 
    loratadine tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem 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
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ASPARTAME (UNII: Z0H242BBR1)  
    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    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11523-4330-11 in 1 CARTON09/25/2015
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:11523-4330-33 in 1 CARTON09/25/2015
    210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:11523-4330-44 in 1 CARTON09/25/2015
    310 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02189109/25/2015
    Labeler - Bayer HealthCare LLC. (112117283)