LORATADINE- loratadine tablet, orally disintegrating 
Dr. Reddy's Laboratories Inc.

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Loratidine Orally Disintegrating Tablets, USP

Drug Facts

Active ingredient (in each tablet)

Loratadine 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 right away.

Directions

adults and children 6 years and over1 tablet daily; not more than 1 tablet 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?

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

Made in India

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Non-Drowsy*

Loratadine Orally Disintegrating Tablets USP, 10 mg

antihistamine

Indoor & Outdoor

Allergies

*When taken as directed. See Drug Facts Panel.

24 Hour Relief of:

Sneezing

Runny Nose

Itchy, Watery Eyes

Itchy Throat or Nose

No Water Needed

Melts in Your Mouth

30

ORALLY

DISINTEGRATING TABLETS

Carton

LORATADINE 
loratadine tablet, orally disintegrating
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43598-707
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE10 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
FlavorMINTImprint Code T10
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43598-707-303 in 1 CARTON07/01/2023
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21329405/19/2021
Labeler - Dr. Reddy's Laboratories Inc. (802315887)

Revised: 6/2023
Document Id: 2316deef-d945-4443-f3d3-dfca67b5439f
Set id: d707733d-1ee9-92d3-f5b2-3567b9c217c2
Version: 1
Effective Time: 20230625
 
Dr. Reddy's Laboratories Inc.