CHILDRENS LORATADINE- loratadine solution 
Taro Pharmaceuticals U.S.A., Inc.

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Children's Loratadine

Drug Facts

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:

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. (1-800-222-1222)

Directions

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 age1 teaspoonful (tsp) daily; do not take more than 1 teaspoonful (tsp) in 24 hours
children under 2 years of ageask a doctor
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:
Taro Pharmaceuticals U.S.A., Inc.
Hawthorne, NY 10532

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton

NDC 51672-2073-8

Compare to the
active ingredient
in Children's Claritin®*

Original
Prescription
Strength

Children's
Loratadine
Oral Solution
USP, 5 mg/5 mL

(Antihistamine)

ALLERGY

Non-Drowsy

24 Hour
Relief of:

Indoor & Outdoor Allergies

Ages 2 years and older

WARNING: Contains sodium metabisulfite,
a sulfite that may cause allergic-type reactions.

Dye Free
Fruit Flavor

Dosage Cup
Enclosed

When taken as directed.
See Drug Facts Panel.

4 FL OZ
(120 mL)

Principal Display Panel - 120 mL Bottle Carton
CHILDRENS LORATADINE 
loratadine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51672-2073
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
FlavorFRUIT (peach) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51672-2073-81 in 1 CARTON08/20/2004
1120 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:51672-2073-41 in 1 CARTON08/20/2004
260 mL in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:51672-2073-51 in 1 CARTON08/20/2004
3180 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07680508/20/2004
Labeler - Taro Pharmaceuticals U.S.A., Inc. (145186370)
Establishment
NameAddressID/FEIBusiness Operations
Taro Pharmaceutical Industries Ltd.600072078MANUFACTURE(51672-2073)

Revised: 1/2020
Document Id: f19e5d03-5c87-46a1-bba0-25c67ab75662
Set id: 78e11f1c-c8a4-4b2a-b7dc-ae1b2dea26d0
Version: 4
Effective Time: 20200123
 
Taro Pharmaceuticals U.S.A., Inc.