Label: CHILDREN CLARITIN ALLERGY- loratadine solution

  • NDC Code(s): 11523-4360-1, 11523-4360-2, 11523-4360-3, 11523-4360-4, view more
    11523-4360-5, 11523-4360-6, 11523-4360-7
  • Packager: Bayer HealthCare LLC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated November 30, 2023

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

View All Sections
  • Drug Facts

  • Active ingredient (in each 5 mL teaspoonful)

    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

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

  • ASK 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

    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.

  • 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.

  • ASK DOCTOR/PHARMACIST

  • Directions

    Use only with enclosed dosing cup

    • adults and children 6 years and over: 2 teaspoonfuls (tsp) daily; do not take more than 2 teaspoonfuls (tsp) in 24 hours
    • children 2 to under 6 years of age: 1 teaspoonful (tsp) daily; do not take more than 1 teaspoonful (tsp) in 24 hours
    • children under 2 years of age: ask a doctor
    • consumers with liver or kidney disease: ask a doctor
  • OTHER SAFETY INFORMATION

    • each teaspoonful contains: sodium 6 mg
    • do not use if tape imprinted with “SEALED FOR YOUR PROTECTION” on top and bottom flaps of carton is not intact.
    • store between 20° and 25°C (68° and 77°F)
  • INACTIVE INGREDIENT

    edetate disodium, flavor, glycerin, maltitol, monobasic sodium phosphate, phosphoric acid, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose

  • Questions or comments?

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

  • PRINCIPAL DISPLAY PANEL

    4 oz. carton label

  • INGREDIENTS AND APPEARANCE
    CHILDREN CLARITIN  ALLERGY
    loratadine solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-4360
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE5 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    MALTITOL (UNII: D65DG142WK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHOSPHORIC ACID (UNII: E4GA8884NN)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11523-4360-51 in 1 CARTON05/26/2015
    1240 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:11523-4360-21 in 1 CARTON09/25/2015
    2120 mL in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:11523-4360-61 in 1 CARTON10/05/2015
    3180 mL in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:11523-4360-41 in 1 CARTON11/01/2015
    430 mL in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:11523-4360-72 in 1 CARTON03/01/2016
    5180 mL in 1 BOTTLE; Type 0: Not a Combination Product
    6NDC:11523-4360-31 in 1 CARTON01/01/2016
    6150 mL in 1 BOTTLE; Type 0: Not a Combination Product
    7NDC:11523-4360-11 in 1 CARTON05/26/2015
    760 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02064105/26/2015
    Labeler - Bayer HealthCare LLC. (112117283)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!