LORATADINE ODT - loratadine tablet, orally disintegrating 
Aurohealth LLC

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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 1-855-274-4122

Distributed by:

AUROHEALTH LLC

2572 Brunswick Pike

Lawrenceville, NJ 08648

Made in India

Code: TS/DRUGS/22/2009

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg, Blister Carton (10 Orally Disintegrating Tablets)

NDC 58602-821-83

PrimaryHEALTH

COMPARE TO Claritin RediTabsActive ingredient**
Non-Drowsy*
Allergy Relief
Loratadine Orally Disintegrating Tablets USP 10 mg
Antihistamine
Indoor & Outdoor Allergies
Original Prescription Strength

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

No Water Needed
Melts in Your Mouth

*When taken as directed. See Drug Facts Panel.

10 Orally Disintegrating Tablets


PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg, Blister Carton (10 Orally Disintegrating Tablets)
LORATADINE ODT 
loratadine tablet, orally disintegrating
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-821
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:58602-821-831 in 1 CARTON04/11/2018
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:58602-821-843 in 1 CARTON04/11/2018
210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20847704/11/2018
Labeler - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
Aurobindo Pharma Limited650381903ANALYSIS(58602-821) , MANUFACTURE(58602-821)

Revised: 11/2022
Document Id: 7564581a-2a15-4c0e-8ae9-459a760613a9
Set id: 9f44382f-c289-402d-bb98-ec5fa80fc25d
Version: 3
Effective Time: 20221103
 
Aurohealth LLC