Label: EQUATE ALLERGY RELIEF- cetirizine hydrochloride tablet

  • NDC Code(s): 49035-458-75, 49035-458-95
  • Packager: Wal-Mart Stores 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 05/09

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

  • Active ingredient (in each tablet)

    Cetirizine HCl 10 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.

    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

    adults and children 6 years and over one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms.
    adults 65 years and over ask a doctor
    children under 6 years of age ask a doctor
    consumers with liver or kidney disease ask a doctor
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  • Other information

    • do not use if printed foil under cap is broken or missing
    • store between 20° to 25°C (68° to 77°F)
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  • Inactive ingredients

    corn starch, FD&C blue no. 1 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, polydextrose, polyethylene glycol, povidone, titanium dioxide, triacetin

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  • Questions or comments?

    1-888-287-1915

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  • Principal Display Panel

    Compare to Zyrtec® Active Ingredient

    Allergy Relief

    Cetirizine Hydrochloride Tablets, 10 mg/Antihistamine

    Indoor and Outdoor Allergies

    24 Hour Relief of:

    Sneezing

    Runny nose

    Itchy, watery eyes

    Itchy throat or nose

    24 HOUR SYMPTOM RELIEF

    Original Prescription Strength

    10 mg

    Actual Size

    Allergy Relief Carton Image 1

    Allergy Relief Carton Image 1

    Allergy Relief Carton Image 2

    Allergy Relief Carton Image 2

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  • INGREDIENTS AND APPEARANCE
    EQUATE ALLERGY RELIEF 
    cetirizine hydrochloride tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:49035-458
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CETIRIZINE HYDROCHLORIDE (CETIRIZINE) CETIRIZINE HYDROCHLORIDE 10 mg
    Inactive Ingredients
    Ingredient Name Strength
    STARCH, CORN  
    HYPROMELLOSES  
    LACTOSE MONOHYDRATE  
    MAGNESIUM STEARATE  
    POLYDEXTROSE  
    POVIDONE  
    TITANIUM DIOXIDE  
    TRIACETIN  
    POLYETHYLENE GLYCOLS  
    Product Characteristics
    Color WHITE Score no score
    Shape OVAL Size 10mm
    Flavor Imprint Code 4H2
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49035-458-95 1 in 1 CARTON
    1 45 in 1 BOTTLE
    2 NDC:49035-458-75 1 in 1 CARTON
    2 90 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA078336 01/09/2008
    Labeler - Wal-Mart Stores Inc (051957769)
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