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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:53329-651
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LORATADINE (LORATADINE) LORATADINE10 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
STARCH, PREGELATINIZED CORN 
Product Characteristics
Colorwhite (White to Off-White) Scoreno score
ShapeROUNDSize6mm
FlavorImprint Code RX526
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53329-651-3330 in 1 BOTTLE
2NDC:53329-651-3890 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07613408/19/2003
Labeler - Medline Industries, Inc. (025460908)
Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
Establishment
NameAddressID/FEIBusiness Operations
Ohm Laboratories Inc.051565745manufacture(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.