Label: CHILDRENS LORATADINE- loratadine solution

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

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 09/12

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient (in each 5 mL)

    Loratadine 5 mg

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  • Purpose

    Antihistamine

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  • 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
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  • 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.

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  • Directions

     adults and children 6 years and over  2 teaspoonfuls daily; do not take more than 2 teaspoonfuls in 24 hours
     children 2 to under 6 years of age  1 teaspoonful daily; do not take more than 1 teaspoonful in 24 hours
     consumers with liver or kidney disease  ask a doctor
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  • 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)
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  • Inactive ingredients

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

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  • SPL UNCLASSIFIED SECTION

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

    Repackaged By:
    Aidarex Pharmaceuticals, LLC.
    Corona, CA 92880

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  • PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton

    NDC 33261-908-01

    Compare to the
    active ingredient
    in 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

    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.

    Image Label
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  • INGREDIENTS AND APPEARANCE
    CHILDRENS LORATADINE 
    loratadine solution
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:33261-908(NDC:51672-2085)
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    LORATADINE (LORATADINE) LORATADINE 5 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    CITRIC ACID MONOHYDRATE  
    GLYCERIN  
    PROPYLENE GLYCOL  
    WATER  
    SODIUM BENZOATE  
    SODIUM METABISULFITE  
    SUCROSE  
    Product Characteristics
    Color YELLOW (colorless to slightly yellow) Score     
    Shape Size
    Flavor GRAPE Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:33261-908-01 5 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA076805 08/20/2004
    Labeler - Aidarex Pharmaceuticals LLC (801503249)
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