LORATADINE - loratadine tablet 
McLane Company, Inc.

----------

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

Distributed by:
Consumer Value Products, Inc.
PO Box 6115, Temple Texas 76502
CVPproducts.com

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


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

NDC 57243-200-69
COMPARE TO
THE ACTIVE INGREDIENT
IN CLARITIN®
CVP HEALTH
NON-DROWSY*  . 24 Hour
ALLERGY RELIEF
LORATADINE TABLETS USP 10 mg
ANTIHISTAMINE
INDOOR & OUTDOOR
ALLERGIES

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 (10 Tablets)
 

LORATADINE 
loratadine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57243-200
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:57243-200-691 in 1 CARTON04/16/2018
110 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 - McLane Company, Inc. (009830555)
Registrant - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
Aurobindo Pharma Limited650381903ANALYSIS(57243-200) , MANUFACTURE(57243-200)

Revised: 11/2022
Document Id: 9874d1db-f339-49f9-8225-ca61c05f1d64
Set id: f988f9fb-463d-4aaa-b83d-54a3b114e570
Version: 4
Effective Time: 20221104
 
McLane Company, Inc.