Label: CETIRIZINE HYDROCHLORIDE - cetirizine hydrochloride solution 

  • Label RSS
  • NDC Code(s): 54838-552-40, 54838-559-40
  • Packager: Silarx Pharmaceuticals, Inc
  • 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 06/14

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

  • Drug Facts

    Active ingredient (in each 5 mL (teaspoonful(tsp)): Cetirizine HCl 5 mg

    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 (tsp)(5 mL) or 2 teaspoonfuls (tsp)(10 mL) once daily depending upon severity of symptoms; do not take more than 2 teaspoonfuls (tsp)(10 mL) in 24 hours.
    adults 65 years and over
    1 teaspoonful (tsp)(5 mL) once daily; do not take more than 1 teaspoonful (tsp)(5 mL) in 24 hours.
    children 2 to under 6 years of age
    1/2 teaspoonful (tsp)(2.5 mL) once daily. If needed, dose can be increased to a maximum of 1 teaspoonful (tsp)(5 mL) once daily or 1/2 teaspoonful (tsp)(2.5 mL) every 12 hours. Do not give more than 1 teaspoonful (tsp)(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 20º to 25ºC (68º to 77ºF)

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  • Inactive ingredients

    calcium acetate, grape flavor, glacial acetic acid, glycerin, methylparaben, propylene glycol, propylparaben, purified water.

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  • Questions?

    Call 1-888-974-5279

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  • Cetirizine Hydrochloride Oral Solution - Hives Relief
  • Drug Facts

    Active ingredient (in each 5 mL (teaspoonful)): Cetirizine HCl 5 mg

    Purpose: Antihistamine

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  • Uses

    relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring.

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  • Warnings

    Severe Allergy Warning: Get emergency help immediately if you have hives along with any of the following symptoms:

    • trouble swallowing
    • dizziness or loss of consciousness
    • swelling of tongue
    • swelling in or around mouth
    • trouble speaking
    • drooling
    • wheezing or problems breathing

    These symptoms may be signs of anaphylactic shock. This condition can be life threatening if not treated by health professional immediately. Symptoms of anaphylactic shock may occur when hives first appear or up to a few hours later.
    Not a Substitute for Epinephrine. If your doctor has prescribed an epinephrine injector for “anaphylaxis” or severe allergy symptoms that could occur with your hives, never use this product as a substitute for the epinephrine injector. If you have been prescribed an epinephrine injector, you should carry it with you at all times.

    Do not use

    • to prevent hives from any known cause such as:
    • foods
    • insect stings
    • medicines
    • latex or rubber gloves because this product will not stop hives from occurring. Avoiding the cause of your hives is the only way to prevent them. Hives can sometimes be serious. If you do not know the cause of your hives, see your doctor for a medical exam. Your doctor may be able to help you find a cause.
    • 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
    • hives that are an unusual color, look bruised or blistered
    • hives that do not itch

    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.
    • symptoms do not improve after 3 days of treatment
    • the hives have lasted more than 6 weeks

    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.

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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 over
    1 teaspoonful (5 mL) once daily; do not take more than 1 teaspoonful (5 mL) in 24 hours
    children under 6 years of age
    ask a doctor
    consumers with liver or kidney disease
    ask a doctor

    Other information
    Store between 20º to 25ºC (68º to 77ºF)

    Close
  • Inactive ingredients

    calcium acetate, grape flavor, glacial acetic acid, glycerin, methylparaben, propylene glycol, propylparaben, purified water

    Close
  • Questions?

    Call 1-888-974-5279

    Close
  • SPL UNCLASSIFIED SECTION

    Dosing Cup Included

    Dosing cup should be washed and left to air dry after each use.

    Do not use if carton is open; or if safety seal printed with “SEALED FOR YOUR PROTECTION” around cap of the bottle is broken or missing.

    SAVE THIS CARTON FOR FULL LABELING INFORMATION

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  • INGREDIENTS AND APPEARANCE
    CETIRIZINE HYDROCHLORIDE 
    cetirizine hydrochloride solution
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:54838-552
    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
    calcium acetate  
    acetic acid  
    glycerin  
    methylparaben  
    propylene glycol  
    propylparaben  
    water  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor GRAPE (Grape Flavor) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54838-552-40 120 mL in 1 CARTON
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA091130 05/02/2011
    CETIRIZINE HYDROCHLORIDE 
    cetirizine hydrochloride solution
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:54838-559
    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
    calcium acetate  
    acetic acid  
    glycerin  
    methylparaben  
    propylene glycol  
    propylparaben  
    water  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor GRAPE (Grape Flavor) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54838-559-40 120 mL in 1 CARTON
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA091130 05/06/2011
    Labeler - Silarx Pharmaceuticals, Inc (161630033)
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