WESTERN FAMILY CHILDRENS ALLERGY RELIEF (LORATADINE) SOLUTION [WESTERN FAMILY FOODS INC]

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WESTERN FAMILY CHILDRENS ALLERGY RELIEF (LORATADINE) SOLUTION [WESTERN FAMILY FOODS INC]
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NDC 55312-092-08
Set ID 2ac0d97a-35a9-4656-a614-1c8c06a89650
Category HUMAN OTC DRUG LABEL
Packager Western Family Foods Inc
Generic Name
Product Class
Product Number
Application Number ANDA076805
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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

    • safety sealed: do not use if imprinted safety seal is torn or missing
    • store between 20° and 25°C (68° and 77°F)
  • Inactive ingredients

    glycerin, grape flavor, maltitol solution, masking agent, noncrystallizing sorbitol solution, phosphoric acid, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium metabisulfite, sodium phosphate monobasic dihydrate, sucralose powder.

  • Questions?

    Call 1-866-923-4914

  • SPL UNCLASSIFIED SECTION

    Proudly Distributed by
    Western Family Foods, Inc.
    P.O. Box 4057, Portland, OR 97208 U.S.A.

  • PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton

    WESTERN FAMILY®

    INDOOR & OUTDOOR ALLERGIES

    Children's
    Allergy
    RELIEF

    24 HOUR
    Non-Drowsy†

    LORATADINE
    ORAL SOLUTION 5 mg / 5 mL
    Antihistamine

    2 years
    and older

    sugar free
    Grape
    flavored
    syrup

    24 HOUR RELIEF OF:
    ✓SNEEZING
    ✓RUNNY NOSE
    ✓ITCHY, WATERY EYES
    ✓ITCHY THROAT OR NOSE

    †When taken as directed. See Drug Facts Panel.

    4 FL OZ (120 mL)

    COMPARE TO THE ACTIVE INGREDIENT IN CHILDREN'S CLARITIN®*

    Principal Display Panel - 120 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    WESTERN FAMILY   CHILDRENS ALLERGY RELIEF
    loratadine solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55312-092
    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
    glycerin (UNII: PDC6A3C0OX)  
    sorbitol (UNII: 506T60A25R)  
    phosphoric acid (UNII: E4GA8884NN)  
    polyethylene glycols (UNII: 3WJQ0SDW1A)  
    propylene glycol (UNII: 6DC9Q167V3)  
    water (UNII: 059QF0KO0R)  
    sodium benzoate (UNII: OJ245FE5EU)  
    sodium metabisulfite (UNII: 4VON5FNS3C)  
    sodium phosphate, monobasic, dihydrate (UNII: 5QWK665956)  
    Product Characteristics
    ColorYELLOW (colorless to slightly yellow) Score    
    ShapeSize
    FlavorGRAPE (sugar free) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55312-092-081 in 1 CARTON
    1120 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07680502/27/2010
    Labeler - Western Family Foods Inc (192166072)
    Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
    Establishment
    NameAddressID/FEIBusiness Operations
    Taro Pharmaceuticals Inc.206263295MANUFACTURE(55312-092)
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