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  5. Label Information: Allergy Relief

FDA Label for Allergy Relief

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH TABLET)
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. OTC - KEEP OUT OF REACH OF CHILDREN
    6. DIRECTIONS
    7. OTHER INFORMATION
    8. INACTIVE INGREDIENTS
    9. QUESTIONS?
    10. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Allergy Relief Product Label

The following document was submitted to the FDA by the labeler of this product Yyba Corp. 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 USP 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 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

Otc - Keep Out Of Reach Of Children



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



ADULTS 65 YEARS OF AGE AND OLDER  

  • ASK A DOCTOR

    • ADULTS AND CHILDREN 12-64 YEARS OF AGE

    • take 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 symptoms

      • CHILDREN 6-11 YEARS OF AGE

      • take ½ tablet (2.5 mg) once daily in the evening
      • do not take more than ½ tablet (2.5 mg) in 24 hours

        • CHILDREN UNDER 6 YEARS OF AGE

        • DO NOT USE

          • CONSUMERS WITH KIDNEY DISEASE

          • DO NOT USE

Other Information



  • store between 20-25°C (68-77°F)
  • safety sealed: do not use if carton was opened or if printed foil inner seal on bottle is torn or missing

Inactive Ingredients



colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide


Questions?



CALL 1-866-933-6337


Package Label.Principal Display Panel




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