LORATADINE ODT- loratadine tablet, orally disintegrating

Loratadine ODT by

Drug Labeling and Warnings

Loratadine ODT by is a Otc medication manufactured, distributed, or labeled by Chain Drug Consortium, LLC, Ranbaxy Pharmaceuticals Inc., Ohm Laboratories Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

INGREDIENTS AND APPEARANCE

LORATADINE ODT 
loratadine tablet, orally disintegrating

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68016-527
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN)	LORATADINE	10 mg

Inactive Ingredients
Ingredient Name	Strength
ASPARTAME (UNII: Z0H242BBR1)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)

Product Characteristics
Color	white (white to off-white)	Score	no score
Shape	ROUND (flat faced beveled edge)	Size	10mm
Flavor	STRAWBERRY, TUTTI FRUTTI, MINT	Imprint Code	RC17
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68016-527-31	30 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA077153	08/31/2007

Labeler - Chain Drug Consortium, LLC (101668460)

Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)

Establishment
Name	Address	ID/FEI	Business Operations
Ohm Laboratories Inc.		051565745	MANUFACTURE(68016-527)