FDA Label for Topcare All Day Allergy

View Indications, Usage & Precautions

Topcare All Day Allergy Product Label

The following document was submitted to the FDA by the labeler of this product Topco Associates Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient (In Each Tablet)



Levocetirizine dihydrochloride 5 mg


Purpose



Antihistamine


Uses



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

  • •runny nose
  • •itchy, watery eyes
  • •sneezing
  • •itching of the nose or throat

Do Not Use



  • •if you have kidney disease
  • •if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing cetirizine

Ask A Doctor Before Use If You Have



  • •ever had trouble urinating or emptying your bladder

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



  • •you have trouble urinating or emptying your bladder
  • •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



ask a doctortake 1 tablet (5 mg) once daily in the evening
  • do not take more than 1 tablet (5 mg) in 24 hours
  • ½ tablet (2.5 mg) once daily in the evening may be appropriate for less severe symptomstake ½ tablet (2.5 mg) once daily in the evening
  • do not take more than ½ tablet (2.5 mg) in 24 hoursdo not usedo not use

    adults 65 years of age and older

    adults and children 12-64 years of age

    children 6-11 years of age

    children under 6 years of age

    consumers with kidney disease


    Other Information



    • •store between 20° and 25°C (68° and 77°F)
    • •do not use if blister unit is broken or torn

    Inactive Ingredients



    hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide


    Questions Or Comments?



    1-888-423-0139


    Package/Label Principal Display Panel



    COMPARE TO XYZAL® ALLERGY 24HR ACTIVE INGREDIENT

    ORIGINAL PRESCRIPTION STRENGTH

    All Day Allergy

    LEVOCETIRIZINE DIHYDROCHLORIDE TABLETS, 5 mg

    ANTIHISTAMINE

    OUR PHARMACISTS RECOMMEND

    INDOOR & OUTDOOR ALLERGIES

    24 HOUR

    RELIEF OF:

    Sneezing

    Runny Nose

    Itchy Nose or throat

    Itchy, Watery Eyes

    10 TABLETS

    actual size


    * Please review the disclaimer below.