LORATADINE- loratadine tablet 
Medline Industries, Inc.

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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:

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

INACTIVE INGREDIENTS

Corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch

QUESTIONS?

Call 1-800-MEDLINE (633-5463), Monday - Friday, 9AM - 5PM CST

PRINCIPAL DISPLAY PANEL

MEDLINE

NDC 53329-651-33

Compare to the active ingredient in Claritin®

NON-DROWSY*

LORATADINE TABLETS, USP 10 mg

ANTIHISTAMINE

ALLERGY RELIEF

Indoor & Outdoor Allergies

24 HOUR RELIEF of:

Sneezing

Runny Nose

Itchy, Watery Eyes

• Itchy Throat or Nose

10 mg

30 Tablets

(When taken as directed. See Drug Facts Panel.)

Distributed by: Medline, Industries, Inc.

5099016/1012

30's bottle label
LORATADINE 
loratadine tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:53329-651
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
STARCH, CORN (UNII: O8232NY3SJ)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
Product Characteristics
Color white (White to Off-White) Score no score
Shape ROUND Size 6mm
Flavor Imprint Code RX526
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:53329-651-33 30 in 1 BOTTLE
2 NDC:53329-651-38 90 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076134 08/19/2003
Labeler - Medline Industries, Inc. (025460908)
Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
Establishment
Name Address ID/FEI Business Operations
Ohm Laboratories Inc. 051565745 manufacture(53329-651)

Revised: 3/2013
Document Id: 8012abf1-23da-4d42-8fb2-b6def38c1c74
Set id: 7a3d416e-ccbe-4823-9c76-ee5b2001599e
Version: 1
Effective Time: 20130322
 
Medline Industries, Inc.