Label: CHILDRENS ALLERGY RELIEF- loratadine solution

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

Drug Label Information

Updated November 27, 2012

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each 5 mL)

    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.
    • side effects occur. You may report side effects to FDA at 1-800-FDA-1088.

    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.

  • Directions

    adults and children 6 years and over2 teaspoonfuls daily; do not take more than 2 teaspoonfuls in 24 hours
    children 2 to under 6 years of age1 teaspoonful daily; do not take more than 1 teaspoonful in 24 hours
    consumers with liver or kidney diseaseask a doctor
  • Other information

    • safety sealed: do not use if imprinted safety seal is torn or missing
    • store between 2° and 25°C (36° and 77°F)
  • Inactive ingredients

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

  • SPL UNCLASSIFIED SECTION

    Distributed by: CVS Pharmacy, Inc., Woonsocket, RI 02895

  • PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton

    CVS®
    pharmacy

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

    Ages
    two years
    and older

    CVS PHARMACIST
    RECOMMENDED

    CHILDREN'S
    ALLERGY
    RELIEF

    LORATADINE ORAL SOLUTION
    5mg/5ml ANTIHISTAMINE

    GRAPE FLAVORED SYRUP

    24 hour Non-Drowsy*
    Allergy

    Relief of:
    Sneezing,
    Runny Nose,
    Itchy, Watery
    Eyes, Itchy
    throat or Nose

    Dye free

    * When taken as directed.
    See Drug Facts Panel.

    4 FL OZ
    (120 mL)

    PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    CHILDRENS ALLERGY RELIEF 
    loratadine solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-446
    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:59779-446-041 in 1 CARTON
    160 mL in 1 BOTTLE
    2NDC:59779-446-081 in 1 CARTON
    2120 mL in 1 BOTTLE
    3NDC:59779-446-011 in 1 CARTON
    3240 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07680508/20/2004
    Labeler - CVS Pharmacy (062312574)
    Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
    Establishment
    NameAddressID/FEIBusiness Operations
    Taro Pharmaceutical Indutries Ltd.600072078MANUFACTURE(59779-446)
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