Label: GOOD SENSE CHILDRENS ALL DAY ALLERGY- cetirizine hcl solution

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

Drug Label Information

Updated March 25, 2016

If you are a consumer or patient please visit this version.

  • Active ingredient (in each 5 mL)

    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
    sneezing
    itchy, watery eyes
    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.
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  • 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
    find right dose on chart below
    mL = milliliter

    adults and children 6 years and over

    5 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 over

    5 mL once daily; do not take more than 5 mL in 24 hours.

    children 2 to under 6 years of age

    2.5 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 age

    ask a doctor

    consumers with liver or kidney disease

    ask a doctor

    Other information

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

    anhydrous citric acid, artificial grape flavor, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose

    Questions or comments?

    1-800-719-9260

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  • Package/Label Principal Display Panel

    2 Yrs. & Older

    Children’s All Day Allergy

    Cetirizine Hydrochloride Oral Solution 1 mg/mL

    Antihistamine

    24 Hour Relief of:

    Sneezing

    Itchy, Watery Eyes

    Runny Nose

    Itchy Throat or Nose

    Indoor & Outdoor Allergies

    Dye-Free

    Sugar-Free

    Dosing Cup Included

    Grape Flavor

    Compare to active ingredient of Children’s Zyrtec®

    4 FL OZ (118 mL)

    Good Sense Children's All Day Allergy image
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  • INGREDIENTS AND APPEARANCE
    GOOD SENSE CHILDRENS ALL DAY ALLERGY 
    cetirizine hcl solution
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0113-0503
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE 5 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor GRAPE Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0113-0503-26 1 in 1 CARTON
    1 118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA204226 01/11/2016
    Labeler - L. Perrigo Company (006013346)
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