Allergy Relief Tablet
FDA Label NDC 73581-201

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Yyba Corp for the product Allergy Relief (NDC 73581-201). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient (in each tablet), purpose, uses, warnings, otc - keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

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