CHILDRENS LORATADINE- loratadine solution 
Kinray, Inc.

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Children's Loratadine Syrup

Drug Facts

Active ingredient (in each 5 mL)

Loratadine 5 mg

Purpose

Antihistamine

Uses

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

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 over2 teaspoonfuls daily; do not take more than 2 teaspoonfuls in 24 hours
children 2 to under 6 years of age1 teaspoonful daily; do not take more than 1 teaspoonful in 24 hours
consumers with liver or kidney diseaseask a doctor

Other information

Inactive ingredients

artificial peach flavor, citric acid monohydrate, glycerin, propylene glycol, purified water, sodium benzoate, sodium metabisulfite, sucrose

Questions?

Call 1-866-923-4914

Distributed by: Kinray, Inc., Whitestone, NY 11357

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton

Preferred
plus
Pharmacy

Compare to the
active ingredient
in Claritin®*

Original
Prescription Strength

ages 2
yrs. &
older

Children's
Loratadine
Syrup

(Loratadine
Oral Solution)
5 mg/5 mL
Antihistamine

Fruit Flavored Syrup
24 hour Non-Drowsy

Allergy Relief

Relief of:
Sneezing; Runny Nose,
Itchy, Watery Eyes,
Itchy Throat or Nose

SATISFACTION
GUARANTEED
Preferred
plus
Pharmacy

4 FL OZ (120 mL)

When taken as directed. See Drug Facts Panel.

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton
CHILDRENS LORATADINE 
loratadine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63777-073
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
citric acid monohydrate (UNII: 2968PHW8QP)  
glycerin (UNII: PDC6A3C0OX)  
propylene glycol (UNII: 6DC9Q167V3)  
water (UNII: 059QF0KO0R)  
sodium benzoate (UNII: OJ245FE5EU)  
sodium metabisulfite (UNII: 4VON5FNS3C)  
sucrose (UNII: C151H8M554)  
Product Characteristics
ColorYELLOW (colorless to slightly yellow) Score    
ShapeSize
FlavorPEACHImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63777-073-081 in 1 CARTON
1120 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07680508/20/2004
Labeler - Kinray, Inc. (012574513)
Establishment
NameAddressID/FEIBusiness Operations
Taro Pharmaceutical Industries, Ltd.600072078MANUFACTURE(63777-073)

Revised: 6/2012
Document Id: 507a8328-ee18-4a50-a16a-959e15407a78
Set id: e4c9553c-0bd8-4654-bb3f-5aa6e0556541
Version: 1
Effective Time: 20120615
 
Kinray, Inc.