LORATADINE- loratadine tablet 
Cardinal Health

----------

Drug Facts

Original Prescription Strength
Non-Drowsy

Indoor and Outdoor Allergies

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:

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

Inactive ingredients

Anhydrous lactose, colloidal silicon dioxide, corn starch, hypromellose, magnesium stearate, microcrystalline cellulose, povidone and sodium lauryl sulfate.

Questions or comments?

1-800-848-0462

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

Distributed by:
UDL Laboratories, Inc.
Rockford, IL 61103

S-10314 R1
7/11

Principal Display Panel

Loratadine Tablets, USP

10 mg

Antihistamine

10 Tablets

bag label
LORATADINE 
loratadine tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:55154-5099(NDC:51079-538)
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
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, CORN (UNII: O8232NY3SJ)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POVIDONES (UNII: FZ989GH94E)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
Product Characteristics
Color WHITE (white to off-white) Score no score
Shape ROUND Size 7mm
Flavor Imprint Code M;L;17
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:55154-5099-0 10 in 1 BAG
1 1 in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075790 11/19/2009
Labeler - Cardinal Health (188557102)
Establishment
Name Address ID/FEI Business Operations
Cardinal Health 188557102 REPACK(55154-5099)

Revised: 3/2013
Document Id: 2d44179c-2f4f-4f84-aeb7-3521f6b2c7cc
Set id: ed094283-40b0-49aa-bbe7-58c6405b1bf0
Version: 4
Effective Time: 20130318
 
Cardinal Health