Loratadine Tablet
FDA Label NDC 84386-119

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Aurobindo Pharma Limited for the product Loratadine (NDC 84386-119). 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, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, 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)

Loratadine USP 10 mg

Purpose

Antihistamine

Uses

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


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

Warnings

Do not use

if you have ever had an allergic reaction to this product or any of its ingredients.

Ask A Doctor Before Use If You Have

liver or kidney disease. Your doctor should determine if you need a different dose.

When Using This Product

do not take more than directed. Taking more than directed may cause drowsiness.

Stop Use And Ask A Doctor If

an allergic reaction to this product occurs. Seek medical help right away.

If Pregnant Or Breast-Feeding,

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 (1-800-222-1222) right away.

Directions

adults and children 6 years and over
1 tablet daily; not more than 1 tablet in 24 hours
children under 6 years of age
ask a doctor
consumers with liver or kidney disease
ask a doctor

Other Information


  • safety sealed: do not use if the individual blister unit is open or torn
  • store at 20° to 25°C (68° to 77°F)
  • protect from excessive moisture

Inactive Ingredients

lactose monohydrate, magnesium stearate, pregelatinized starch (maize), sodium starch glycolate.

Questions Or Comments?


call 1-855-274-4122

Distributed by:
Aurobindo Pharma USA, Inc.
279 Princeton-Hightstown Road
East Windsor, NJ 08520
 Made in India


Package Label-Principal Display Panel - 10 Mg Blister Carton (100 Tablets)

AUROBINDO

NDC 84386-119-78


#Compare to the active
ingredient in Claritin®
 

Non-Drowsy*

Loratadine
Tablets USP 10 mg

 Antihistamine

 Indoor & Outdoor Allergies

24
Hour
Relief of:

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

    • *When taken as directed.
    See Drug Facts Panel.

     

     100 Tablets  

      

    Package Label-principal Display Panel (10 mg Blister Carton (100 Tablets))

    Package Label-principal Display Panel (10 mg Blister Carton (100 Tablets))

* Please review the disclaimer below.