Label: CHILDRENS LORATADINE- loratadine solution

  • NDC Code(s): 51672-2085-1, 51672-2085-4, 51672-2085-5, 51672-2085-8
  • Packager: Taro Pharmaceuticals U.S.A., Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated January 24, 2020

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  • SPL UNCLASSIFIED SECTION

    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
    • 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. (1-800-222-1222)

  • Directions

    • use only with enclosed dosing cup
    adults and children 6 years and over2 teaspoonfuls (tsp) daily; do not take more than 2 teaspoonfuls (tsp) in 24 hours
    children 2 to under 6 years of age1 teaspoonful (tsp) daily; do not take more than 1 teaspoonful (tsp) in 24 hours
    children under 2 years of ageask a doctor
    consumers with liver or kidney diseaseask a doctor
  • Other information

    • do not use if carton is opened, or if imprinted safety seal is broken or missing
    • see bottom panel for expiration date
    • store between 20° to 25°C (68° to 77°F)
  • Inactive ingredients

    artificial grape flavor, citric acid monohydrate, glycerin, propylene glycol, purified water, sodium benzoate, sodium metabisulfite, sucrose

  • Questions?

    Call 1-866-923-4914

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Taro Pharmaceuticals U.S.A., Inc.
    Hawthorne, NY 10532

  • PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton

    NDC xxxxx-xxxx-x

    Compare to the
    active ingredient
    in Children's Claritin®*

    GRAPE
    FLAVOR

    Original
    Prescription Strength

    Ages two years and older

    Children's
    Loratadine
    Syrup
    (Loratadine
    Oral Solution)
    5 mg/5 mL
    Antihistamine

    Grape Flavored Syrup

    24 Hour Non-Drowsy†
    Allergy Relief

    Indoor &
    Outdoor
    Allergies

    Relief of:
    Sneezing; Runny Nose,
    Itchy, Watery Eyes,
    Itchy Throat or Nose

    4 FL OZ (120 mL)

    † When taken as directed. See Drug Facts Panel.

    PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    CHILDRENS LORATADINE 
    loratadine solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51672-2085
    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
    citric acid monohydrate (UNII: 2968PHW8QP)  
    glycerin (UNII: PDC6A3C0OX)  
    propylene glycol (UNII: 6DC9Q167V3)  
    water (UNII: 059QF0KO0R)  
    sodium benzoate (UNII: OJ245FE5EU)  
    sodium metabisulfite (UNII: 4VON5FNS3C)  
    sucrose (UNII: C151H8M554)  
    Product Characteristics
    ColorYELLOW (colorless to slightly yellow) Score    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51672-2085-81 in 1 CARTON08/20/2004
    1120 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:51672-2085-41 in 1 CARTON08/20/2004
    260 mL in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:51672-2085-51 in 1 CARTON08/20/2004
    3180 mL in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:51672-2085-11 in 1 CARTON08/20/2004
    4240 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07680508/20/2004
    Labeler - Taro Pharmaceuticals U.S.A., Inc. (145186370)
    Establishment
    NameAddressID/FEIBusiness Operations
    Taro Pharmaceutical Industries Ltd.600072078MANUFACTURE(51672-2085)
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