LORATADINE ODT- loratadine tablet, orally disintegrating

Loratadine ODT by

Drug Labeling and Warnings

Loratadine ODT by is a Otc medication manufactured, distributed, or labeled by Rugby Laboratories, Aurohealth LLC, Aurobindo Pharma Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

• runny nose
• sneezing
• itchy, watery eyes
• 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

• 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.

INGREDIENTS AND APPEARANCE

LORATADINE ODT 
loratadine tablet, orally disintegrating

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0536-1367
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN)	LORATADINE	10 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	WHITE (White to Off-white)	Score	no score
Shape	ROUND (Biconvex)	Size	8mm
Flavor	PEPPERMINT	Imprint Code	K;9
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0536-1367-07	3 in 1 CARTON	10/06/2022
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA208477	10/06/2022

Labeler - Rugby Laboratories (079246066)

Registrant - Aurohealth LLC (078728447)

Establishment
Name	Address	ID/FEI	Business Operations
Aurobindo Pharma Limited		650381903	ANALYSIS(0536-1367) , MANUFACTURE(0536-1367)