Label: LORATADINE- loratadine oral solution

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

Drug Label Information

Updated April 19, 2021

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

View All Sections
  • Drug Facts

    Active ingredient (in each 5 mL teaspoonful)
    Loratadine USP 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 (1-800-222-1222) right away.

  • 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 information

    • each teaspoonful contains: sodium 6 mg
    • do not use if carton is opened, or if cap safety seal is broken or missing.
    • store at 20° to 25°C (68° to 77°F)
  • Inactive ingredients

    artificial flavors, ascorbic acid, glycerin, maltitol, monobasic sodium phosphate monohydrate, phosphoric acid, propylene glycol, purified water, sodium benzoate, sodium metabisulfite, sorbitol, sucralose.

  • Questions or comments?

    1-800-632-6900

    DISTRIBUTRD BY THE KROGER CO.
    CINCINNATI, OHIO 45202
    MADE IN INDIA

     Code:TS/DRUGS/19/1993

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg/5 mL  (120 mL Bottle)

    NDC 30142-062-24
    Kroger®
    Ages 2 Years & Older

    children's
    Allergy Relief

    Loratadine Oral
    Solution USP,
    5 mg/5 mL
    Antihistamine
    INDOOR & OUTDOOR
    ALLERGIES     

    24 HOUR
    DYE-FREE
    Grape Flavor
    4 FL OZ (120 mL)

    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg/5 mL (60 mL Bottle)

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg/5 mL Carton (120 mL)

    COMPARE TO the active ingredient of
    CHILDRENS'S CLARITIN® **See side panel
    NDC 30142-062-24

    Kroger®
    Ages     2 Years & Older
    Non-Drowsy*
    children's
    Allergy Relief
    Loratadine Oral
    Solution USP, 5 mg/5 mL
    Antihistamine
    INDOOR & OUTDOOR ALLERGIES
    24 HOUR RELIEF OF:


    Sneezing; Runny Nose;
    Itchy,watery Eyes &
    Itchy Throat or Nose
    Contains sodium metabisulfite,
    a sulfite that may cause
    allergic-type reactions.

    Dosing
    Cup Included


    DYE-FREE
    Grape Flavor

     4 FL OZ (120 mL)

     * When taken as directed.

    See Drug Facts Panel.

    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg/5 mL Carton (60 mL)


  • INGREDIENTS AND APPEARANCE
    LORATADINE 
    loratadine oral solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-062
    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
    GRAPE (UNII: 6X543N684K)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MALTITOL (UNII: D65DG142WK)  
    SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)  
    PHOSPHORIC ACID (UNII: E4GA8884NN)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorYELLOW (colorless to light yellow) Score    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:30142-062-241 in 1 CARTON03/15/2021
    1120 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20893103/15/2021
    Labeler - KROGER COMPANY (006999528)
    Registrant - Aurohealth LLC (078728447)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aurobindo Pharma Limited918917642ANALYSIS(30142-062) , MANUFACTURE(30142-062)
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!