LORATADINE- loratadine tablet, orally disintegrating 
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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 (1-800-222-1222).

DIRECTIONS

OTHER INFORMATION

INACTIVE INGREDIENTS

Aspartame, croscarmellose sodium, fruit flavors, magnesium stearate, mannitol, sodium stearyl fumarate

QUESTIONS?

Call 1-800-406-7984

PRINCIPAL DISPLAY PANEL

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NDC 15127-979-10

NON-DROWSY*

Original Prescription Strength

Allergy Relief Tablets

Loratadine Orally Disintegrating Tablets, 10 mg

Antihistamine

24 Hour Allergy Relief

Indoor & Outdoor Allergies

No Water Needed

Melts in Your Mouth

Relief of: Sneezing; Runny Nose;

Itchy, Watery Eyes; Itchy Throat or Nose

For Adults & Children six years & older!

10 Orally Disintegrating Tablets

٭Compare to the active ingredient of Claritin®RediTabs®

*When taken as directed. See Drug Facts Panel.

Distributed by: SELECT BRAND®DISTRIBUTORS

5079375/R0610

This is the 10 count blister carton label for Select Brand Loratadine ODT.
LORATADINE 
loratadine tablet, orally disintegrating
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15127-979
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE10 mg
Inactive Ingredients
Ingredient NameStrength
ASPARTAME (UNII: Z0H242BBR1)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MANNITOL (UNII: 3OWL53L36A)  
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
Product Characteristics
Colorwhite (White to Off-White) Scoreno score
ShapeROUND (Flat faced beveled edge) Size10mm
FlavorFRUITImprint Code RC17
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:15127-979-1010 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07715308/31/2007
Labeler - Select Brand (043562370)
Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
Establishment
NameAddressID/FEIBusiness Operations
Ohm Laboratories Inc.051565745manufacture(15127-979)

Revised: 10/2012
Document Id: a90cd258-ffa6-44e9-aaa0-04bdae94487e
Set id: abeae0a6-7f41-45e3-b2ae-145a2e633bc7
Version: 1
Effective Time: 20121002
 
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