Your browser does not support JavaScript! LORATADINE TABLET [MYLAN PHARMACEUTICALS INC.]
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RxNorm Names

LORATADINE tablet
[Mylan Pharmaceuticals Inc.]


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

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

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 of kidney disease

ask a doctor

Other information

Tamper Evident: do not use if foil seal under cap is missing, open or broken.
store between 20° to 25°C (68° to 77°F)
protect from excessive moisture

Inactive ingredients

Corn starch, lactose monohydrate and magnesium stearate.

Questions or comments?

call 1-877-446-3679 (1-877-4-INFO-RX)

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

Made in India
Code No.: MH/DRUGS/25/NKD/89

PRODUCT PACKAGING

NDC 0378-8880-93

Original Prescription Strength

Non-Drowsy*

Loratadine
Tablets USP, 10 mg

Antihistamine

Indoor and Outdoor Allergies

24 Hour Relief of:

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose

*When taken as directed. See Drug Facts Panel.

RMX8880H1

30 Tablets

Loratadine Tablets 10 mg Bottles Front First Layer
Loratadine Tablets 10 mg Bottles Back of Front Layer
Loratadine Tablets 10 mg Bottles Second Layer
Loratadine Tablets 10 mg Bottles Back of Second Layer
Loratadine Tablets 10 mg Bottles Back of Front Layer
Loratadine Tablets 10 mg Bottles Front Layer
Loratadine Tablets 10 mg Bottles Second Front Layer
Loratadine Tablets 10 mg Bottles Base Layer
LORATADINE 
loratadine tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0378-8880
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 Code G;L;10
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0378-8880-9330 in 1 BOTTLE, PLASTIC
2NDC:0378-8880-101000 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07615403/27/2013
Labeler - Mylan Pharmaceuticals Inc. (059295980)

Revised: 11/2013
 
Mylan Pharmaceuticals Inc.

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