Label: LORATADINE- loratadine oral solution

  • NDC Code(s): 68001-449-98
  • Packager: BluePoint Laboratories
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated July 31, 2020

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  • 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?

    Call 1-855-274-4122



    Manufactured by:

    Aurobindo Pharma Limited

    Hyderabad-500 090,

    India

    For BluePoint Laboratories



    Made in India


    Code:TS/DRUGS/19/1993

    Issued: 06/2020

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

    NDC 68001-449-98



    Ages

    2 years

    and older

    Loratadine

    Oral Solution USP

    5 mg/5 mL



    Antihistamine

    Non-Drowsy*



    24 Hour Relief of:

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

    Do not use if carton is opened,

    or if cap safety seal is broken

    or missing.

    • Dye-Free
    • Sugar-Free
    • Alcohol Free

    Indoor & Outdoor Allergies

    Contains sodium metabisulfite,

    a sulfite that may cause

    allergic-type reactions.

    * When taken as directed. See Drug Facts Panel.



    Grape Flavor



    4FL OZ (120 mL)

    Loratadine OS Label

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

    NDC 68001-449-98

    #Compare to the

    active ingredient in

    children’s Claritin®



    Ages

    2years

    and older



    Loratadine

    Oral Solution USP

    5 mg/5 mL



    Antihistamine



    Non-Drowsy*



    24 Hour Relief of:

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

    Indoor & Outdoor Allergies



    Dosing Cup Included

    • Dye-Free

    Contains sodium

    metabisulfite, a sulfite

    that may cause

    allergic-type reactions.

    * When taken as directed.

    See Drug Facts Panel.



    Grape

    Flavor



    4 FL OZ (120 mL)

    Loratadine OS Carton





  • INGREDIENTS AND APPEARANCE
    LORATADINE 
    loratadine oral solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68001-449
    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:68001-449-981 in 1 CARTON07/31/2020
    1120 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20893107/31/2020
    Labeler - BluePoint Laboratories (985523874)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aurobindo Pharma Limited918917642analysis(68001-449) , manufacture(68001-449)
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