L
Dosage Form: tablet
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:
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 or kidney disease
ask a doctor
Other Information
Safety sealed: do not use if the imprinted bottle seal is open or torn (for bottle only).
Safety sealed: do not use if open or torn (for blister package only).
Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature).
Inactive Ingredients
Lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate.
Questions or comments?
1-800-525-8747
05-2010M
Sandoz Inc.
Princeton, NJ 08540
mg Label
NDC 0781-5077-01 Non-Drowsy*
LORAtadine
Tablets, USP
10 mg
Antihistamine
Indoor & Outdoor Allergies
100 Tablets
SANDOZ
24 Hour
Relief of:
Sneezing
Runny Nose
Itchy, Watery
Eyes
Itchy Throat
or Nose
* When taken as directed.
See Drug Facts Panel.
mg Blister Pack
NDC 0781-5077-64
LORAtadine Tablets, USP 10 mg
10-2009M
mg Blister Pack Carton
NDC 0781-5077-64
Non-Drowsy*
LORAtadine
Tablets, USP
10 mg Antihistamine
Indoor & Outdoor Allergies
30 Tablets
SANDOZ
24 Hour
Relief of:
Sneezing
Runny Nose
Itchy, Watery
Eyes
Itchy Throat
or Nose
LORATADINE
loratadine tablet
Product Information
Product Type
HUMAN OTC DRUG
NDC Product Code (Source)
0781-5077
Route of Administration
ORAL
DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name
Basis of Strength
Strength
LORATADINE (LORATADINE)
LORATADINE
10 mg
Inactive Ingredients
Ingredient Name
Strength
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color
WHITE (white to off white)
Score
no score
Shape
ROUND
Size
6mm
Flavor
Imprint Code
GG296
Contains
Packaging
#
NDC
Package Description
Multilevel Packaging
1
0781-5077-76
12 CARTON In 1 CARTON
contains a CARTON (0781-5077-64)
1
0781-5077-64
1 BLISTER PACK In 1 CARTON
This package is contained within the CARTON (0781-5077-76) and contains a BLISTER PACK
1
30 TABLET In 1 BLISTER PACK
This package is contained within a CARTON (0781-5077-64) and a CARTON (0781-5077-76)
2
0781-5077-01
100 TABLET In 1 BOTTLE
None
Marketing Information
Marketing Category
Application Number or Monograph Citation
Marketing Start Date
Marketing End Date
ANDA
ANDA075209
01/21/2003
Labeler - Sandoz Inc (110342024)
Establishment
Name
Address
ID/FEI
Operations
Sandoz Inc
110342024
MANUFACTURE
Establishment
Name
Address
ID/FEI
Operations
Thermo-Pak, Inc
161049044
PACK, LABEL
Revised: 06/2010Sandoz Inc
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