CLARITIN- loratadine tablet, chewable 
Bayer HealthCare LLC.

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Claritin ®

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 AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE5 mg
Inactive Ingredients
Ingredient NameStrength
ASPARTAME (UNII: Z0H242BBR1)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MANNITOL (UNII: 3OWL53L36A)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
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 DescriptionMarketing Start DateMarketing End Date
1NDC:11523-7198-11 in 1 CARTON06/01/201512/31/2016
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:11523-7198-21 in 1 CARTON06/01/201512/31/2016
25 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:11523-7198-32 in 1 POUCH; Type 0: Not a Combination Product06/01/201512/31/2016
4NDC:11523-7198-42 in 1 CARTON06/01/201512/31/2016
410 in 1 BLISTER PACK; Type 0: Not a Combination Product
5NDC:11523-7198-53 in 1 CELLO PACK06/01/201512/31/2016
51 in 1 CARTON
510 in 1 BLISTER PACK; Type 0: Not a Combination Product
6NDC:11523-7198-62.5 in 1 PACKAGE, COMBINATION06/01/201512/31/2016
610 in 1 BLISTER PACK; Type 0: Not a Combination Product
7NDC:11523-7198-72 in 1 CELLO PACK06/01/201512/31/2016
72 in 1 CARTON
710 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02189103/05/200912/31/2016
Labeler - Bayer HealthCare LLC. (112117283)

Revised: 5/2017
Document Id: 4fa9482a-ee6d-1afd-e054-00144ff8d46c
Set id: 3e267980-115b-4672-9c4c-0807e475034f
Version: 5
Effective Time: 20170516
 
Bayer HealthCare LLC.