Label: ALLERGY RELIEF- loratadine solution

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

Drug Label Information

Updated October 23, 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 peach flavor, citric acid monohydrate, glycerin, propylene glycol, purified water, sodium benzoate, sodium metabisulfite, sucrose

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Medicine Shoppe International, Inc.
    St. Louis, Missouri 63132

  • PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton

    The Medicine
    Shoppe    ®

    †COMPARE TO
    ACTIVE INGREDIENT
    IN CHILDREN'S
    CLARITIN    ®

    NDC 49614-174-26

    NON-DROWSY*

    Allergy
    Relief
    for
    kids
    Loratadine Oral Solution 5 mg/5 mL
    Antihistamine

    RELIEF OF:

    ▶
    SNEEZING
    ▶
    RUNNY NOSE
    ▶
    ITCHY, WATERY EYES
    ▶
    ITCHY THROAT OR NOSE

    FRUIT FLAVORED
    SYRUP

    Ages two years
    and older

    ALCOHOL FREE

    DYE FREE

    *When taken as directed.
    See Drug Facts Panel.

    24
    Hour

    4 FL OZ
    (120 mL)

    PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF 
    loratadine solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49614-174
    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
    FlavorFRUITImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49614-174-261 in 1 CARTON
    1120 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07680508/20/2004
    Labeler - Medicine Shoppe International Inc (071997654)
    Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
    Establishment
    NameAddressID/FEIBusiness Operations
    Taro Pharmaceutical Industries Ltd.600072078MANUFACTURE(49614-174)
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