Label: QUALITY CHOICE  CHILDRENS ALLERGY RELIEF- loratadine solution 

  • Label RSS
  • NDC Code(s): 63868-156-04
  • Packager: Chain Drug Marketing Association
  • 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 10/12

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

    Close
  • Active ingredient (in each 5 mL)

    Loratadine 5 mg

    Close
  • Purpose

    Antihistamine

    Close
  • 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
    Close
  • 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.

    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.

    Close
  • 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
    Close
  • 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)
    Close
  • Inactive ingredients

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

    Close
  • Questions?

    call 1-800-935-2362

    Close
  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY QUALITY CHOICE 43157 WEST NINE MILE ROAD
    NOVI, MI 48376-0995

    Close
  • PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

    Compare to the
    active ingredient in
    Claritin®

    QC
    QUALITY
    CHOICE®

    NDC 63868-156-04

    NON-DROWSY*

    Children's
    ALLERGY
    RELIEF

    (Loratadine
    Oral Solution)
    5 mg/5 mL
    Antihistamine

    Ages two years
    and older

    24 Hour
    Allergy Relief

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

    Grape Flavored
    Syrup

    4 FL OZ
    (118 mL)

    *When taken as directed. See Drug Facts Panel.

    PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton
    Close
  • INGREDIENTS AND APPEARANCE
    QUALITY CHOICE   CHILDRENS ALLERGY RELIEF
    loratadine solution
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:63868-156
    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:63868-156-04 1 in 1 CARTON
    1 118 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 - Chain Drug Marketing Association (011920774)
    Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
    Establishment
    Name Address ID/FEI Business Operations
    Taro Pharmaceutical Industries Ltd. 600072078 MANUFACTURE(63868-156)
    Close