Label: SIMPLY RIGHT CHILDRENS CETIRIZINE- cetirizine hydrochloride solution

  • NDC Code(s): 68196-102-01, 68196-102-02, 68196-102-07
  • Packager: Sam's West Inc
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated July 20, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each 5 mL)

    Cetirizine HCl 5 mg

  • Purpose

    Antihistamine

  • Uses

    temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

    • runny nose
    • sneezing
    • itchy, watery eyes
    • 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 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)

  • Directions

    • use only with enclosed dosing cup
    • find right dose on chart below
    • mL = milliliter
    adults and children 6 years and over5 mL or 10 mL once daily depending upon severity of symptoms; do not take more than 10 mL in 24 hours.
    adults 65 years and over5 mL once daily; do not take more than 5 mL in 24 hours.
    children 2 to under 6 years of age2.5 mL once daily. If needed, dose can be increased to a maximum of 5 mL once daily or 2.5 mL every 12 hours. Do not give more than 5 mL in 24 hours.
    children under 2 years of ageask a doctor
    consumers with liver or kidney diseaseask a doctor
  • Other information

    • do not use if carton is opened or if imprinted safety seal is broken or missing
    • see bottom panel for lot number and expiration date
    • store between 20° to 25°C (68° to 77°F)
  • Inactive ingredients

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

  • Questions?

    Call 1-866-923-4914

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY:
    SAM'S WEST, INC.
    BENTONVILLE, AR 72716

  • PRINCIPAL DISPLAY PANEL - 2 x 240 mL Bottle Carton

    Twin Pack – 2 X 8 FL OZ

    Compare to Children's Zyrtec® active ingredient*

    NDC 68196-102-07

    Member's Mark™

    24 hour relief

    original prescription strength

    children's
    cetirizine

    hydrochloride oral solution
    1 mg/mL antihistamine
    allergy

    24 hour relief of:

    • Sneezing; runny nose; itchy,
    watery eyes; itchy throat or nose
    • Indoor & outdoor allergies
    • Sugar free • Dye free
    2 years and older

    Grape flavor
    Dosing cup included

    Contains 2 bottles of 8 FL OZ (240 mL)
    each/total 16 FL OZ (480mL)

    PRINCIPAL DISPLAY PANEL - 2 x 240 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    SIMPLY RIGHT   CHILDRENS CETIRIZINE
    cetirizine hydrochloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68196-102
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Cetirizine Hydrochloride (UNII: 64O047KTOA) (Cetirizine - UNII:YO7261ME24) Cetirizine Hydrochloride5 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    acetic acid (UNII: Q40Q9N063P)  
    glycerin (UNII: PDC6A3C0OX)  
    methylparaben (UNII: A2I8C7HI9T)  
    propylene glycol (UNII: 6DC9Q167V3)  
    propylparaben (UNII: Z8IX2SC1OH)  
    water (UNII: 059QF0KO0R)  
    sodium acetate anhydrous (UNII: NVG71ZZ7P0)  
    sucralose (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorYELLOW (colorless to slightly yellow) Score    
    ShapeSize
    FlavorGRAPE (sugar free) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68196-102-022 in 1 CARTON09/08/2011
    1120 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:68196-102-012 in 1 CARTON09/08/2011
    2240 mL in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:68196-102-072 in 1 CARTON09/08/2011
    3240 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09018209/08/2011
    Labeler - Sam's West Inc (051957769)
    Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
    Establishment
    NameAddressID/FEIBusiness Operations
    Taro Pharmaceutical Industries Ltd.600072078MANUFACTURE(68196-102)
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