Levocetirizine Dihydrochloride Tablet, Coated
FDA Label NDC 43598-735

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dr. Reddy's Laboratories Inc. for the product Levocetirizine Dihydrochloride (NDC 43598-735). 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, do not use, ask a doctor before use if you have, when using this product, stop use and ask doctor if, 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 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 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-feding: 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

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
  • 1/2 tablet (2.5 mg) once daily in the evening may be appropriate for less severe symptoms
children 6-11 years of age
  • take 1/2 tablet (2.5 mg) once daily in the evening
  • do not take more than 1/2 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° and 25°C (68° and 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, titanium dioxide

Questions Or Comments?

Call 1-888-375-3784

Levocetirizine Dihydrochloride Tablets, Usp 5 Mg Carton Label

Dr. Reddy's
NDC 43598-669-35

Original Prescription Strength

Levocetirizine
Dihydrochloride
Tablets USP, 5 mg
Antihistamine

ALLERGY

24 HOUR

Relief of:

  • Sneezing
  • Runny Nose
  • Itchy Nose or Throat
  • Itchy, Watery Eyes

    • 35 Tablets


    Dr. Reddy's
    NDC 43598-735-35

    Original Prescription Strength

    Levocetirizine
    Dihydrochloride
    Tablets USP, 5 mg
    Antihistamine

    ALLERGY

    24 HOUR

    Relief of:

    • Sneezing
    • Runny Nose
    • Itchy Nose or Throat
    • Itchy, Watery Eyes

      • 35 Tablets

      Carton735 (Carton735)

      Carton735 (Carton735)


Levocetirizine Dihydrochloride Tablets Usp, 5 Mg Bottle Label

NDC 43598-669-35
Dr.Reddy's

Original Prescription Strength
Levocetirizine
Dihydrochloride Tablets USP, 5 mg
Antihistamine

ALLERGY

24 HOUR

35 Tablets

NDC 43598-735-35
Dr.Reddy's

Original Prescription Strength
Levocetirizine
Dihydrochloride Tablets USP, 5 mg
Antihistamine

ALLERGY

24 HOUR

35 Tablets

Bottle735 (Bottle735)

Bottle735 (Bottle735)

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