LORATADINE- loratadine tablet 
Select Brand

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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 over1 tablet daily; not more than 1 tablet in 24 hours
children under 6 years of ageask a doctor
consumers with liver or kidney diseaseask a doctor

OTHER INFORMATION

INACTIVE INGREDIENTS

Corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch

QUESTIONS?

Call 1-800-406-7984

PRINCIPAL DISPLAY PANEL

*Compare to the active ingredient of Claritin®

NDC 15127-715-30

select brand®

NON-DROWSY٭

Allergy Relief

Loratadine Tablets USP, 10 mg

Antihistamine

INDOOR & OUTDOOR ALLERGIES

RELIEF OF:

Sneezing; Runny Nose; Itchy, Watery Eyes; Itchy Throat or Nose

24 Hour Allergy Relief

30 Tablets

٭When taken as directed. See Drug Facts Panel.

Distributed by: SELECT BRAND DISTRIBUTORS

5069402/1008

This is the 30 count blister carton label for Select Brand Loratadine tablets.
LORATADINE 
loratadine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15127-715
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE10 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
Product Characteristics
Colorwhite (White to Off-White) Scoreno score
ShapeROUNDSize6mm
FlavorImprint Code RX526
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:15127-715-1010 in 1 BLISTER PACK
2NDC:15127-715-3030 in 1 BLISTER PACK
3NDC:15127-715-6060 in 1 BOTTLE
4NDC:15127-715-01100 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07613408/19/2003
Labeler - Select Brand (043562370)
Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
Establishment
NameAddressID/FEIBusiness Operations
Ohm Laboratories Inc.051565745manufacture(15127-715)

Revised: 10/2012
Document Id: 73e2a4b3-c024-4b6a-8a92-519df6c3f202
Set id: 14c00a0a-3522-4f11-b409-8b1dcd18798e
Version: 1
Effective Time: 20121002
 
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