CLARITIN- loratadine solution 
Bayer HealthCare LLC.

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Children's Claritin ®



Loratadine Oral Solution

Active ingredient (in each 5 mL teaspoonful)

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

Use only with enclosed dosing cup

  • adults and children 6 years and over: 2 teaspoonfuls (TSP) daily; do not take more than 2 teaspoonfuls (TSP) in 24 hours
  • children 2 to under 6 years of age: 1 teaspoonful (TSP) daily; do not take more than 1 teaspoonful (TSP) in 24 hours
  • children under 2 years of age: ask a doctor
  • consumers with liver or kidney disease: ask a doctor

Other information

  • each teaspoonful contains: sodium 5 mg
  • do not use if tape imprinted with "SEALED FOR YOUR PROTECTION" on top and bottom flaps of carton is not intact.
  • store between 20° and 25°C (68° and 77°F)

Inactive ingredients

edetate disodium, flavor, glycerin, maltitol, monobasic sodium phosphate, phosphoric acid, propylene glycol, sodium benzoate, sorbitol, sucralose, purified water

Questions or comments?

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

© Copyright & Distributed by Bayer HealthCare LLC, Whippany, NJ, USA, 07981.

PRINCIPAL DISPLAY PANEL - 60 ml Bottle Carton

NDC 11523-7197-2

Dye-Free

ages
2 years
and older ®

Children's
Claritin ®
Allergy

loratadine oral solution
5 mg/5 mL-antihistamine

Non-Drowsy*

24 Hour Relief of:

  • Sneezing
  • Runny Nose
  • Itchy, Watery Eyes
  • Itchy Throat or Nose

Indoor & Outdoor
Allergies

DYE-FREE

2 FL OZ
(60 ml)

Grape
Taste

*When taken as directed.
See Drug Facts Panel.

PRINCIPAL DISPLAY PANEL - 60 ml Bottle Carton
CLARITIN 
loratadine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-7197
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCERIN (UNII: PDC6A3C0OX)  
MALTITOL (UNII: D65DG142WK)  
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)  
PHOSPHORIC ACID (UNII: E4GA8884NN)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11523-7197-11 in 1 CARTON03/01/201101/01/2018
1120 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:11523-7197-21 in 1 CARTON03/01/201101/01/2018
260 mL in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:11523-7197-31 in 1 CARTON03/01/201101/01/2018
320 mL in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:11523-7197-61 in 1 CARTON03/01/201101/01/2018
4150 mL in 1 BOTTLE; Type 0: Not a Combination Product
5NDC:11523-7197-42 in 1 CELLO PACK03/01/201101/01/2018
5120 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02064103/01/201101/01/2018
Labeler - Bayer HealthCare LLC. (112117283)

Revised: 3/2018
Document Id: 66c520a6-021b-5cff-e053-2991aa0a5c4a
Set id: fe8f8a37-e82c-4cca-8306-14d6c892ebbd
Version: 10
Effective Time: 20180306
 
Bayer HealthCare LLC.