LORATADINE ANTIHISTAMINE- loratadine tablet 
Cardinal Health

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Perrigo Loratadine Tablets, 10 mg Drug Facts

Active ingredient (in each tablet)

Loratadine 10 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

runny nose
sneezing
itchy, watery eyes
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

do not use if printed foil under cap is broken or missing
store at 20°-25°C (68°-77°F)

Inactive ingredients

lactose monohydrate, magnesium stearate, povidone, pregelatinized starch

Questions or comments?

1-800-719-9260

Generic Section

Antihistamine 24 Hour

Indoor & Outdoor Allergies

Non-Drowsy*

*When taken as directed. See Drug Facts Panel.

Original Prescription Strength

Compare to Claritin® active ingredient

PERRIGO®

Distributed BY

PERRIGO®

ALLEGAN, MI 49010

IT49413401113

Cardinal Health

Zanesville, OH 43701

Principal Display Panel

Loratadine 10 mg

tablets

card label

Principal Display Panel

Loratadine 10 mg

tablets

QTY 30

lidding label

Principal Display Panel

Loratadine 10 mg

tablets

card label

Principal Display Panel

Loratadine 10 mg

tablets

QTY 28

lidding label
LORATADINE  ANTIHISTAMINE
loratadine tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:55154-1954(NDC:45802-650)
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE 10 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POVIDONES (UNII: FZ989GH94E)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 8mm
Flavor Imprint Code L612
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:55154-1954-9 30 in 1 BLISTER PACK; Type 0: Not a Combination Product
2 NDC:55154-1954-3 28 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076301 10/15/2008
Labeler - Cardinal Health (188557102)
Establishment
Name Address ID/FEI Business Operations
Cardinal Health 188557102 REPACK(55154-1954)

Revised: 3/2015
Document Id: 327970c6-9c78-42d3-aabe-7b56da54e205
Set id: 3ea9fa14-2d88-4809-a588-a248c51eebf0
Version: 3
Effective Time: 20150317
 
Cardinal Health