CLARITIN- loratadine tablet, chewable 
MSD Consumer Care, Inc.

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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 overchew 2 tablets daily; not more than 2 tablets in 24 hours
children 2 to under 6 years of agechew 1 tablet daily; not more than 1 tablet in 24 hours
children under 2 years of ageask a doctor
consumers with liver or kidney diseaseask 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

© Copyright & Distributed by MSD Consumer Care, Inc., PO Box 377, Memphis, TN 38151 USA, a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ USA.

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-7198
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Loratadine (Loratadine) Loratadine5 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorPURPLE (light to medium purple with a slightly speckled and/or mottled appearance) Scoreno score
ShapeROUND (flat faced beveled edge) Size10mm
FlavorGRAPEImprint Code Claritin;5
Contains    
Packaging
#Item CodePackage Description
1NDC:11523-7198-11 in 1 CARTON
110 in 1 BLISTER PACK
2NDC:11523-7198-21 in 1 CARTON
25 in 1 BLISTER PACK
3NDC:11523-7198-32 in 1 POUCH
4NDC:11523-7198-42 in 1 CARTON
410 in 1 BLISTER PACK
5NDC:11523-7198-53 in 1 CELLO PACK
51 in 1 CARTON
510 in 1 BLISTER PACK
6NDC:11523-7198-62.5 in 1 PACKAGE, COMBINATION
610 in 1 BLISTER PACK
7NDC:11523-7198-72 in 1 CELLO PACK
72 in 1 CARTON
710 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02189103/05/2009
Labeler - MSD Consumer Care, Inc. (968091715)

Revised: 09/2012
Document Id: 20df3386-5287-4f7b-8657-e4698b315e44
Set id: 3e267980-115b-4672-9c4c-0807e475034f
Version: 3
Effective Time: 20120904
 
MSD Consumer Care, Inc.