LORATADINE- loratadine tablet 
Cardinal Health

----------

Loratadine Tablet 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

1.
safety sealed: do not use if induction seal, with "Lift N Peel" tab, under cap is broken or missing
2.
store between 2° and 30°C (36° and 86°F)
3.
protect from exceesive moisture

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose

Manufactured by:

Manufactured for:

Apotex Inc.

Apotex Corp.

Toronto, Ontario

Weston, Florida

Canada M9L 1T9

33326

Revised: March 2005


Cardinal Health

Zanesville, OH 43701

IH50553140115

Principal Display Panel

Loratadine Tablet, USP

10 mg

lidding label

Principal Display Panel

Loratadine Tablets, USP

10 mg

100 Tablets

Carton label

Principal Display Panel

Loratadine Tablets, USP

10 mg

carton
LORATADINE 
loratadine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-6676(NDC:60505-0147)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE10 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize8mm
FlavorImprint Code LOR;10;APO
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55154-6676-4100 in 1 CARTON01/24/200509/30/2017
1NDC:55154-6676-71 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07647101/24/200509/30/2017
Labeler - Cardinal Health (188557102)
Registrant - Apotex Inc. (209429182)
Establishment
NameAddressID/FEIBusiness Operations
Cardinal Health188557102REPACK(55154-6676)

Revised: 2/2018
Document Id: 79557b6e-f606-4c7d-986c-f844591c4c56
Set id: e966546e-8a66-43c2-8432-d7139dc7e770
Version: 2
Effective Time: 20180205
 
Cardinal Health