LORATADINE - loratadine tablet, orally disintegrating
Topco Associates LLC

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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, magnesium stearate, mannitol, mint flavor, sodium stearyl fumarate, strawberry cream flavor, tutti-frutti flavor

QUESTIONS?

call 1-888-423-0139

PRINCIPAL DISPLAY PANEL

Topcare®

NDC 36800-513-12

MELT-IN-YOUR-MOUTH TABLETS. NO WATER NEEDED

Original Prescription Strength

24 HOUR NON-DROWSY*

Allergy Relief

LORATADINE ORALLY DISINTEGRATING TABLETS, USP 10 mg

ANTIHISTAMINE

Indoor & Outdoor Allergies

For Adults and Children six years and older!

For 24 Hour Relief of:

Sneezing
Runny Nose
Itchy, Watery Eyes
Itching of Nose & Throat

COMPARE TO ALAVERT®active ingredient†

12 ORALLY DISINTEGRATING TABLETS

*When taken as directed. See Drug Facts Panel.

DISTRIBUTED BY TOPCO ASSOCIATES LLC

5095019/R0812

This is the blister carton label for 12 count Loratadine orally disintegrating tablets, topcare.

LORATADINE
loratadine tablet, orally disintegrating

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:36800-513
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LORATADINE (LORATADINE)	LORATADINE	10 mg

Inactive Ingredients
Ingredient Name	Strength
ASPARTAME
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
MANNITOL
SODIUM STEARYL FUMARATE

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	Multilevel Packaging
1	NDC:36800-513-12	12 TABLET, ORALLY DISINTEGRATING ( TABLET) in 1 BLISTER PACK	None
2	NDC:36800-513-24	24 TABLET, ORALLY DISINTEGRATING ( TABLET) in 1 BLISTER PACK	None

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

Labeler - Topco Associates LLC (006935977)

Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)

Establishment
Name	Address	ID/FEI	Operations
Ohm Laboratories Inc.		184769029	manufacture

Revised: 04/2012 Topco Associates LLC

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