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 over2 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 grape 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 xxxxx-xxxx-x

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

GRAPE
FLAVOR

Original
Prescription Strength

Ages two years and older

Children's
Loratadine
Syrup
(Loratadine
Oral Solution)
5 mg/5 mL
Antihistamine

Grape Flavored Syrup

24 Hour Non-Drowsy
Allergy Relief

Indoor &
Outdoor
Allergies

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

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:51672-2085
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
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51672-2085-81 in 1 CARTON08/20/2004
1120 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:51672-2085-41 in 1 CARTON08/20/2004
260 mL in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:51672-2085-51 in 1 CARTON08/20/2004
3180 mL in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:51672-2085-11 in 1 CARTON08/20/2004
4240 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(51672-2085)

Revised: 1/2020
Document Id: d8ae719e-320f-43b3-ba1c-61cfd42d164b
Set id: 12c8066a-3429-481e-b63a-7ea2b439a170
Version: 3
Effective Time: 20200124
 
Taro Pharmaceuticals U.S.A., Inc.