Your browser does not support JavaScript! LORATADINE TABLET [MYLAN INSTITUTIONAL INC.]
DailyMed Logo Header image

Daily Med

Current Medication Information

Options

RxNorm Names

LORATADINE tablet
[Mylan Institutional Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL Abbreviated New Drug Application
Drug Label Sections

Original Prescription Strength
Non-Drowsy

Indoor and Outdoor Allergies

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:

  • runny nose
  • itchy, watery eyes
  • sneezing
  • itching of the nose or throat

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 ageask a doctor

consumers with liver
or kidney disease

ask a doctor

Other information

  • TAMPER EVIDENT: DO NOTUSE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
  • store between 20° to 25°C (68° to 77°F)
  • protect from excessive moisture

Inactive ingredients

Anhydrous lactose, colloidal silicon dioxide, corn starch, hypromellose, magnesium stearate, microcrystalline cellulose, povidone and sodium lauryl sulfate.

Questions or comments?

1-800-848-0462

  • Serious side effects associated with use of this product may be reported to this number.

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

Distributed by:
UDL Laboratories, Inc.
Rockford, IL 61103

S-10314 R1
7/11


PRINCIPAL DISPLAY PANEL

NDC 51079-538-20

LORATADINE
TABLETS, USP
10 mg

Antihistamine
100 Tablets (10 x 10)

Original Prescription Strength   Non-Drowsy*
*When taken as directed. See enclosed leaflet.

Indoor and Outdoor Allergies

24 Hour Relief (See Uses section of enclosed leaflet)
TAMPER EVIDENT: DO NOT USE IF
BLISTER UNITS ARE TORN, BROKEN OR
SHOW ANY SIGNS OF TAMPERING

Drug Facts

Active Ingredient (in each tablet) Purpose
Loratadine USP, 10 mg . . . . . . . . . . . Antihistamine

Uses See enclosed leaflet

Warnings See enclosed leaflet

Directions See enclosed leaflet

Other Information

  • TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
  • store between 20° to 25°C (68° to 77°F) ̣̣
  • protect from excessive moisture

Inactive ingredients Anhydrous lactose, colloidal
silicon dioxide, corn starch, hypromellose, magnesium
stearate, microcrystalline cellulose, povidone and sodium
lauryl sulfate.

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

S-10315 R1

Packaged and Distributed by:
UDL LABORATORIES, INC.
ROCKFORD, IL 61103

This unit dose package is not child resistant.

For institutional use only.

Keep this and all drugs out of the reach of children.

This container provides light-resistance.

See window for lot number and expiration date.

Loratadine Tablets 10 mg
Unit Carton
LORATADINE 
loratadine tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:51079-538
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LORATADINE (LORATADINE) LORATADINE10 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS LACTOSE 
SILICON DIOXIDE 
STARCH, CORN 
HYPROMELLOSES 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POVIDONE 
SODIUM LAURYL SULFATE 
Product Characteristics
ColorWHITE (white to off-white) Scoreno score
ShapeROUNDSize7mm
FlavorImprint Code M;L;17
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51079-538-20100 in 1 BOX, UNIT-DOSE
1NDC:51079-538-011 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07579006/06/2012
Labeler - Mylan Institutional Inc. (039615992)

Revised: 7/2011
 
Mylan Institutional Inc.

Visit The National Library of Medicine Copyright, Privacy, Accessibility
U.S. National Library of Medicine, 8600 Rockville Pike, Bethesda, MD 20894
National Institutes of Health, Health & Human Services