LORATADINE- loratadine tablet 
Mylan Institutional Inc.

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Drug Facts

   

Original Prescription Strength Non-Drowsy*

Indoor and Outdoor Allergies

*When taken as directed. See Drug Facts Panel.

TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.

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 right away.

Directions (24 Hour Relief)

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

Corn starch, lactose monohydrate and magnesium stearate.

Questions or comments?

1-800-848-0462

Manufactured for:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Made in India

Code No.: MH/DRUGS/25/NKD/89

Distributed by:
Mylan Institutional Inc.
Rockford, IL 61103 U.S.A.

S-11333 R2
11/16

     

PRINCIPAL DISPLAY PANEL – 10 mg

NDC 51079-246-20

Loratadine
Tablets, USP
10 mg

Antihistamine

Original Prescription Strength    Non-Drowsy*

Indoor and Outdoor Allergies

24 Hour Relief (See Uses section of enclosed leaflet)

*When taken as directed. See enclosed leaflet.

TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE
TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.

Loratadine Tablets, USP 10 mg Carton Label
Outer Carton Label
LORATADINE 
loratadine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51079-246
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE10 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
Product Characteristics
Colorwhite (white to off-white) Scoreno score
ShapeROUNDSize6mm
FlavorImprint Code G;L;10
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51079-246-20100 in 1 BOX, UNIT-DOSE04/30/201301/31/2030
1NDC:51079-246-011 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07615404/30/201301/31/2030
Labeler - Mylan Institutional Inc. (039615992)

Revised: 12/2021
Document Id: d43835d4-30dc-1b0f-e053-2995a90aa367
Set id: 1fc9ddd1-393d-4fe2-a9e0-d192df7331db
Version: 8
Effective Time: 20211228
 
Mylan Institutional Inc.