Label: PREMIER VALUE  CHILDRENS LORATADINE- loratadine solution 

  • Label RSS
  • NDC Code(s): 68016-164-01
  • Packager: Chain Drug Constortium
  • 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 03/14

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 teaspoonful)

    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.

    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)

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  • Directions

    • use only with enclosed dosing cup
    adults and children 6 years and over 2 teaspoonfuls (tsp) daily; do not take more than 2 teaspoonfuls (tsp) in 24 hours
    children 2 to under 6 years of age 1 teaspoonful (tsp) daily; do not take more than 1 teaspoonful (tsp) in 24 hours
    children under 2 years of age ask a doctor
    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 20° and 25°C (68° and 77°F)
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  • 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.

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  • Questions?

    Call 1-866-923-4914

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  • SPL UNCLASSIFIED SECTION

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

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  • 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
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  • INGREDIENTS AND APPEARANCE
    PREMIER VALUE   CHILDRENS LORATADINE
    loratadine solution
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:68016-164
    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
    glycerin  
    sorbitol  
    phosphoric acid  
    polyethylene glycols  
    propylene glycol  
    water  
    sodium benzoate  
    sodium metabisulfite  
    sodium phosphate, monobasic, dihydrate  
    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:68016-164-01 1 in 1 CARTON
    1 120 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA076805 02/27/2010
    Labeler - Chain Drug Constortium (101668460)
    Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
    Establishment
    Name Address ID/FEI Business Operations
    Taro Pharmaceutical Industries Ltd. 600072078 MANUFACTURE(68016-164)
    Establishment
    Name Address ID/FEI Business Operations
    Taro Pharmaceuticals Inc. 206263295 MANUFACTURE(68016-164)
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