LORATADINE - loratadine tablet 
Chain Drug Consortium, LLC

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Loratadine 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

lactose monohydrate, magnesium stearate, pregelatinized starch (maize), sodium starch glycolate.

Questions or comments?


call 1-855-274-4122

#This product is not manufactured or distributed by Bayer Healthcare LLC distributor of Claritin®.

Distributed By:
Pharmacy Value Alliance LLC
407 East Lancaster Avenue,
Wayne, PA 19087


Made in India
Code: TS/DRUGS/22/2009

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (60 Tablets Bottle)

#COMPARE TO THE ACTIVE
INGREDIENT IN CLARITIN®
Non-Drowsy*
Premier
Value®
Loratadine
Tablets USP 10 mg
Allergy Relief
Antihistamine

Indoor & Outdoor
Allergies

24 Hour Relief of:

• Sneezing
• Runny Nose
• Itchy, Watery Eyes
• Itchy Throat or Nose 

60 Tablets
*When taken as directed See Drug Facts Panel.
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (60 Tablets Bottle)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg Container Carton (60 Tablets)

#COMPARE TO THE ACTIVE
INGREDIENT IN CLARITIN®
Non-Drowsy*

Premier
Value®
Loratadine Tablets USP 10 mg
Allergy
Relief
Antihistamine
Indoor & Outdoor Allergies

24 Hours Relief of:

• Sneezing
• Runny Nose
• Itchy, Watery Eyes
• Itchy Throat or Nose

60 Tablets
*When taken as directed
See Drug Facts Panel.
 PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (60 Tablets Bottle)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg Blister Carton (30 Tablets)

#COMPARE TO THE ACTIVE
INGREDIENT IN CLARITIN®
Non-Drowsy*

Premier
Value®
Loratadine Tablets USP 10 mg
Allergy Relief
Antihistamine
Indoor & Outdoor
Allergies

24 Hours Relief of:

• Sneezing
• Runny Nose
• Itchy, Watery Eyes
• Itchy Throat or Nose

10 Tablets
*When taken as directed See Drug Facts Panel.
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg Blister Carton (30 Tablets) 

LORATADINE 
loratadine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-094
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE10 mg
Inactive Ingredients
Ingredient NameStrength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
STARCH, CORN (UNII: O8232NY3SJ)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
Product Characteristics
ColorWHITE (White to Off-white) Scoreno score
ShapeROUNDSize6mm
FlavorImprint Code 39;L
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68016-094-601 in 1 CARTON04/16/2018
160 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:68016-094-901 in 1 CARTON04/16/2018
290 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:68016-094-101 in 1 CARTON04/16/2018
310 in 1 BLISTER PACK; Type 0: Not a Combination Product
4NDC:68016-094-303 in 1 CARTON04/16/2018
410 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20831404/16/2018
Labeler - Chain Drug Consortium, LLC (101668460)
Registrant - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
Aurobindo Pharma Limited650381903ANALYSIS(68016-094) , MANUFACTURE(68016-094)

Revised: 11/2022
Document Id: 29355692-7b20-4b38-8611-8a8f86e636a7
Set id: 21199958-ac67-4f72-8a8c-4d7d31fa9da4
Version: 5
Effective Time: 20221104
 
Chain Drug Consortium, LLC