LORATADINE- loratadine tablet 
Dr. Reddy's Laboratories Inc.

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Loratadine Orally Disintegrating Tablets USP

Drug Facts

Active ingredient (in each tablet)

Loratadine 5 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 right away.

Directions

adults and children 6 years and over1 tablet every 12 hours; not more than 2 tablets in 24 hours
children under 6 years of ageask a doctor
consumers with liver or kidney diseaseask a doctor

Other information

Inactive ingredients

anhydrous citric acid, mannitol, peppermint flavor, polysorbate 80, pullulan

Questions or comments?

Questions or Comments? call toll-free weekdays 9 AM to 8 PM EST at 1-888-375-3784

Distributed by:

Dr. Reddy’s Laboratories Inc.,

Princeton, NJ 08540

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Palceholder

LORATADINE 
loratadine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43598-756
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE5 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
PULLULAN (UNII: 8ZQ0AYU1TT)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
MANNITOL (UNII: 3OWL53L36A)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize12mm
FlavorPEPPERMINTImprint Code T5
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43598-756-101 in 1 CARTON07/14/2023
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:43598-756-303 in 1 CARTON07/14/2023
210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21279505/19/2021
Labeler - Dr. Reddy's Laboratories Inc. (802315887)

Revised: 2/2023
Document Id: 33224371-b336-2c1e-63dd-7a8ce9d195ff
Set id: 9357186a-9452-e139-01d8-6b8c6f6a2c6b
Version: 1
Effective Time: 20230224
 
Dr. Reddy's Laboratories Inc.