Active ingredient (in each tablet)

Loratadine 5 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

runny nose
sneezing
itchy, watery eyes
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.

Directions

adults and children 6 years and over	chew 2 tablets daily; not more than 2 tablets in 24 hours
children 2 to under 6 years of age	chew 1 tablet daily; not more than 1 tablet in 24 hours
children under 2 years of age	ask a doctor
consumers with liver or kidney disease	ask a doctor

Other information

phenylketonurics: contains phenylalanine 1.4 mg per tablet
safety sealed: do not use if the individual blister unit imprinted with Children's Claritin® is open or torn
store between 20° to 25°C (68° to 77°F)

Inactive ingredients

aspartame, citric acid anhydrous, colloidal silicon dioxide, D&C red No. 27 aluminum lake, FD&C blue No. 2 aluminum lake, flavor, magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate, stearic acid

Questions or comments?

1-800-CLARITIN (1-800-252-7484) or www.claritin.com

PRINCIPAL DISPLAY PANEL - 10 Tablets Carton

NDC 11523-7198-1

ages
2 years
and older®

Children's
Claritin®

Allergy

loratadine 5 mg/antihistamine

Non-Drowsy*

24 Hour Relief of:

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose

Indoor & Outdoor
Allergies

10 CHEWABLE TABLETS

Grape
Flavored
Chewables

*When taken as directed. See Drug Facts Panel.

PRINCIPAL DISPLAY PANEL - 10 Tablets Carton

CLARITIN
loratadine tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11523-7198
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Loratadine (Loratadine)	Loratadine	5 mg

Inactive Ingredients
Ingredient Name	Strength
aspartame
anhydrous citric acid
silicon dioxide
D&C red No. 27
FD&C blue No. 2
aluminum oxide
magnesium stearate
mannitol
cellulose, microcrystalline
stearic acid

Product Characteristics
Color	PURPLE (light to medium purple with a slightly speckled and/or mottled appearance)	Score	no score
Shape	ROUND (flat faced beveled edge)	Size	10mm
Flavor	GRAPE	Imprint Code	Claritin;5
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:11523-7198-1	1 BLISTER PACK in 1 CARTON	contains a BLISTER PACK
1		10 TABLET, CHEWABLE in 1 BLISTER PACK	This package is contained within the CARTON (11523-7198-1)
2	NDC:11523-7198-2	1 BLISTER PACK in 1 CARTON	contains a BLISTER PACK
2		5 TABLET, CHEWABLE in 1 BLISTER PACK	This package is contained within the CARTON (11523-7198-2)
3	NDC:11523-7198-3	2 TABLET, CHEWABLE in 1 POUCH	None
4	NDC:11523-7198-4	2 BLISTER PACK in 1 CARTON	contains a BLISTER PACK
4		10 TABLET, CHEWABLE in 1 BLISTER PACK	This package is contained within the CARTON (11523-7198-4)
5	NDC:11523-7198-5	3 CARTON in 1 CELLO PACK	contains a CARTON
5		1 BLISTER PACK in 1 CARTON	This package is contained within the CELLO PACK (11523-7198-5) and contains a BLISTER PACK
5		10 TABLET, CHEWABLE in 1 BLISTER PACK	This package is contained within a CARTON and a CELLO PACK (11523-7198-5)
6	NDC:11523-7198-6	2.5 BLISTER PACK in 1 PACKAGE, COMBINATION	contains a BLISTER PACK
6		10 TABLET, CHEWABLE in 1 BLISTER PACK	This package is contained within the PACKAGE, COMBINATION (11523-7198-6)
7	NDC:11523-7198-7	2 CARTON in 1 CELLO PACK	contains a CARTON
7		2 BLISTER PACK in 1 CARTON	This package is contained within the CELLO PACK (11523-7198-7) and contains a BLISTER PACK
7		10 TABLET, CHEWABLE in 1 BLISTER PACK	This package is contained within a CARTON and a CELLO PACK (11523-7198-7)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA021891	03/05/2009

Labeler - MSD Consumer Care, Inc. (968091715)

Revised: 07/2012 MSD Consumer Care, Inc.