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Loratadine by Mylan Institutional Inc.

Medically reviewed on Dec 13, 2016

Dosage form: tablet
Ingredients: LORATADINE 10mg
Labeler: Mylan Institutional Inc.
NDC Code: 51079-246

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:

  • 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 age

ask a doctor

consumers with liver
or kidney disease

ask a doctor

Other information
  • TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
  • Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]
  • protect from excessive moisture

Inactive Ingredients

Corn starch, lactose monohydrate and magnesium stearate.

Questions or comments?

1-800-848-0462

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

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 
loratadine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51079-246
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LORATADINE (LORATADINE) LORATADINE10 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
Product Characteristics
Colorwhite (white to off-white) Scoreno score
ShapeROUNDSize6mm
FlavorImprint CodeG;L;10
Contains    
Packaging
#Item CodePackage Description
1NDC:51079-246-20100 BLISTER PACK in 1 BOX, UNIT-DOSE
1NDC:51079-246-011 TABLET in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07615404/30/2013
Labeler - Mylan Institutional Inc. (039615992)

 
Mylan Institutional Inc.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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