LORATADINE ODT - loratadine tablet, orally disintegrating 
Rugby Laboratories

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Loratadine Orally Disintegrating Tablets USP 10 mg

Drug Facts

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:

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

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

LORATADINE ODT 
loratadine tablet, orally disintegrating
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1367
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE10 mg
Inactive Ingredients
Ingredient NameStrength
ASPARTAME (UNII: Z0H242BBR1)  
CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK)  
MANNITOL (UNII: 3OWL53L36A)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
PEPPERMINT (UNII: V95R5KMY2B)  
STARCH, CORN (UNII: O8232NY3SJ)  
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
Product Characteristics
ColorWHITE (White to Off-white) Scoreno score
ShapeROUND (Biconvex) Size8mm
FlavorPEPPERMINTImprint Code K;9
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-1367-073 in 1 CARTON10/06/2022
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20847710/06/2022
Labeler - Rugby Laboratories (079246066)
Registrant - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
Aurobindo Pharma Limited650381903ANALYSIS(0536-1367) , MANUFACTURE(0536-1367)

Revised: 10/2022
Document Id: f59f3400-da77-4eb7-be02-842071d87fae
Set id: f59f3400-da77-4eb7-be02-842071d87fae
Version: 1
Effective Time: 20221006
 
Rugby Laboratories