Label: SIMPLY RIGHT  CHILDRENS CETIRIZINE- cetirizine hydrochloride solution 

  • 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 01/13

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)

    Cetirizine HCl 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 or to an antihistamine containing hydroxyzine.

    Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.

    Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.

    When using this product

    • drowsiness may occur
    • avoid alcoholic drinks
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • be careful when driving a motor vehicle or operating machinery

    Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

    If pregnant or breast-feeding:

    • if breast-feeding: not recommended
    • if pregnant: 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 1 teaspoonful (5 mL) or 2 teaspoonfuls (10 mL) once daily depending upon severity of symptoms; do not take more than 2 teaspoonfuls (10 mL) in 24 hours.
    adults 65 years and older 1 teaspoonful (5 mL) once daily; do not take more than 1 teaspoonful (5 mL) in 24 hours.
    children 2 to under 6 years of age ½ teaspoonful (2.5 mL) once daily. If needed, dose can be increased to a maximum of 1 teaspoonful (5 mL) once daily or ½ teaspoonful (2.5 mL) every 12 hours. Do not give more than 1 teaspoonful (5 mL) 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

    • store between 20° to 25°C (68° to 77°F)
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  • Inactive ingredients

    artificial grape flavor, glacial acetic acid, glycerin, methylparaben, natural and artificial banana flavor, propylene glycol, propylparaben, purified water, sodium acetate (anhydrous), sucralose

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  • Questions?

    Call 1-866-923-4914

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  • SPL UNCLASSIFIED SECTION

    Distributed by:
    SAM'S West, Inc.
    Bentonville, AR 72716

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  • PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton

    TWIN PACK

    NDC 68196-102-02
    24 hour relief

    SIMPLY RIGHT
    Health Care

    Original prescription strength

    children's
    cetirizine

    hydrochloride
    oral solution 1 mg/mL

    antihistamine

    Compare to Children's Zyrtec®
    active ingredient*

    allergy

    24 hour relief of:
    sneezing; runny nose;
    itchy, watery eyes;
    itchy throat or nose

    indoor &
    outdoor
    allergies

    2 yrs. & older

    grape flavor

    4 FL OZ (120 mL)
    Dosing cup included

    Principal Display Panel - 120 mL Bottle Carton
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  • INGREDIENTS AND APPEARANCE
    SIMPLY RIGHT   CHILDRENS CETIRIZINE
    cetirizine hydrochloride solution
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:68196-102
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Cetirizine Hydrochloride (Cetirizine) Cetirizine Hydrochloride 5 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    acetic acid  
    glycerin  
    methylparaben  
    propylene glycol  
    propylparaben  
    water  
    sodium acetate anhydrous  
    sucralose  
    Product Characteristics
    Color YELLOW (colorless to slightly yellow) Score     
    Shape Size
    Flavor GRAPE (sugar free) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68196-102-02 2 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 ANDA090182 09/08/2011
    Labeler - Sam's West Inc (051957769)
    Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
    Establishment
    Name Address ID/FEI Business Operations
    Taro Pharmaceutical Industries Ltd. 600072078 MANUFACTURE(68196-102)
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