Label: PREMIER VALUE CHILDRENS LORATADINE- loratadine solution

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

Drug Label Information

Updated March 21, 2014

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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

    DISTRIBUTED BY
    CHAIN DRUG CONSORTIUM
    3301 NW BOCA RATON BLVD
    SUITE 101, BOCA RATON, FL 33431

  • PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton

    NDC 68016-164-01

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

    Premier
    Value

    Ages
    two years
    and older

    Children's
    Loratadine
    Oral Solution
    5 mg/5 mL
    Antihistamine

    SUGAR FREE
    GRAPE     flavor

    Non-Drowsy†

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

    INDOOR & OUTDOOR
    ALLERGIES

    †When taken as directed.
    See Drug Facts Panel.

    INDEPENDENTLY TESTED
    P
    V
    SATISFACTION GUARANTEED

    4 FL OZ
    (120 mL)

    PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    PREMIER VALUE   CHILDRENS LORATADINE
    loratadine solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-164
    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
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68016-164-011 in 1 CARTON
    1120 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07680502/27/2010
    Labeler - Chain Drug Constortium (101668460)
    Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
    Establishment
    NameAddressID/FEIBusiness Operations
    Taro Pharmaceutical Industries Ltd.600072078MANUFACTURE(68016-164)
    Establishment
    NameAddressID/FEIBusiness Operations
    Taro Pharmaceuticals Inc.206263295MANUFACTURE(68016-164)
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