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Care One (American Sales Company)

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SOLUTION 1 BOTTLE in 1 CARTON (41520-092-08) > 120 mL in 1 BOTTLE Label Information

Complete Care One Information

  • 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 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

  • Other information

    • do not use if carton is opened, or if imprinted safety seal is broken or missing
    • see bottom panel for expiration date
    • 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


  • PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton

    NDC 41520-092-08

    Compare to the
    Active Ingredient
    in Children's
    Claritin®*

    CAREONE®

    24 HOUR/NON-DROWSY†
    SUGAR FREE

    CHILDREN'S
    ALLERGY RELIEF

    (Loratadine Oral Solution)
    5 mg/5 mL Antihistamine

    Indoor & Outdoor Allergies
    DYE FREE

    GRAPE FLAVORED
    SYRUP
    Ages two years and older

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

    Dosage Cup
    Enclosed

    4 FL OZ
    [120 mL]

    † When taken as directed.
    See Drug Facts Panel.

    Principal Display Panel - 120 mL Bottle Carton

  • INGREDIENTS AND APPEARANCE
    CARE ONE   CHILDRENS LORATADINE
    loratadine solution
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:41520-092
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Loratadine (UNII: 7AJO3BO7QN) (Loratadine - UNII:7AJO3BO7QN) Loratadine 5 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    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
    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:41520-092-08 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 - American Sales Company (809183973)
    Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
    Establishment
    Name Address ID/FEI Business Operations
    Taro Pharmaceutical Indutries Ltd. 600072078 MANUFACTURE(41520-092)
    Establishment
    Name Address ID/FEI Business Operations
    Taro Pharmaceuticals Inc. 206263295 MANUFACTURE(41520-092)