LORATADINE ODT- loratadine tablet, orally disintegrating 
Chain Drug Consortium, LLC

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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:

runny nose
itchy, watery eyes
sneezing
itching of the nose or throat

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

place 1 tablet on tongue; tablet disintegrates, with or without water

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

Phenylketonurics: Contains Phenylalanine 0.6 mg Per Tablet.
TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
store between 20° to 25° C (68° to 77° F). Protect from excessive moisture.
keep in a dry place.
use tablet immediately after opening individual blister.

INACTIVE INGREDIENTS

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

QUESTIONS?

call 1-800-406-7984

Keep the carton. It contains important information.

See end panel for expiration date.

DISTRIBUTED BY

CHAIN DRUG CONSORTIUM

3301 NW BOCA RATON BLVD

SUITE 101, BOCA RATON, FL 33431

PRINCIPAL DISPLAY PANEL

Premier Value®

NDC 68016-527-31

Original Prescription Strength

NON-DROWSY*

24 Hour Allergy Relief

Loratadine Orally Disintegrating Tablets, 10 mg

Allergy Relief

Antihistamine

Indoor & Outdoor Allergies

No water needed. Melts in your mouth.

Relief of:

Sneezing
Itchy, Watery Eyes
Runny Nose
Itchy Throat or Nose

For Adults and Children six years and older!

30 ORALLY DISINTEGRATING TABLETS

COMPARE TO THE ACTIVE INGREDIENT OF CLARITIN®REDITABS®†

*When taken as directed. See Drug Facts Panel.

This product is not manufactured or distributed by Schering-Plough HealthCare Products, Inc. CLARITIN® and REDITABS® are registered trademarks of Schering Corporation.

This is the 30 count blister carton label for Premier Value Loratadine ODT, USP 10 mg.
LORATADINE ODT 
loratadine tablet, orally disintegrating
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-527
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
FlavorSTRAWBERRY, TUTTI FRUTTI, MINTImprint Code RC17
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68016-527-3130 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07715308/31/2007
Labeler - Chain Drug Consortium, LLC (101668460)
Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
Establishment
NameAddressID/FEIBusiness Operations
Ohm Laboratories Inc.051565745MANUFACTURE(68016-527)

Revised: 10/2015
Document Id: ffe62d63-befe-4308-a676-12b3e179a32b
Set id: 26a7a473-3b88-4aa6-be56-da315e7556b6
Version: 3
Effective Time: 20151008
 
Chain Drug Consortium, LLC