Loratadine Odt Tablet, Orally Disintegrating
FDA Label NDC 0536-1367

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rugby Laboratories for the product Loratadine Odt (NDC 0536-1367). 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, do not use, 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
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat

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


  • place 1 tablet on tongue; tablet disintegrates, with or without water 

    •  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

  • Phenylketonurics: Contains phenylalanine 2.25 mg per tablet
  • do not use if the individual blister unit is open or torn
  • store at 20° to 25°C (68° to 77°F)
  • use tablet immediately after opening individual blister
  • Complies with USP test 2 for Disintegration

Inactive Ingredients

aspartame, crospovidone, mannitol, microcrystalline cellulose,  peppermint, pregelatinized starch (maize), sodium stearyl fumarate

Questions Or Comments?

call 1-800-616-2471

Distributed by:
RUGBY® LABORATORIES
Indianapolis, IN 46268
www.majorpharmaceuticals.com


Made in India

Code: TS/DRUGS/22/2009

Package Label-Principal Display Panel - 10 Mg, Blister Carton 30 (3 X 10) Orally Disintegrating Tablets

Rugby®                             

NDC 0536-1367-07
Compare to the
active ingredient in
Claritin® RediTabs®**
  

Original Prescription Strength     
Non-Drowsy*                          
Loratadine Orally Disintegrating            
Tablets USP                                              
10 mg                                                         
                                                                
Antihistamine                          

Indoor & Outdoor Allergies

24 Hour

NO WATER
NEEDED
MELTS IN
YOUR MOUTH

Relief of:
• Sneezing
• Runny Nose
• Itchy, Watery Eyes                               
• Itchy Throat or Nose

30 (3 X 10) Orally Disintegrating Tablets               

*When taken as directed. See Drug Facts Panel.

Package Label-principal Display Panel (10 mg, Blister Carton 30 (3 X 10) Orally Disintegrating Tablets)

Package Label-principal Display Panel (10 mg, Blister Carton 30 (3 X 10) Orally Disintegrating Tablets)

* Please review the disclaimer below.