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

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Children's Loratadine Oral Solution
Sugar Free

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

bubble gum flavor, butylated hydroxyanisole, glycerin, maltitol solution, noncrystallizing sorbitol solution, phosphoric acid, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium phosphate monobasic dihydrate, sucralose powder

Questions?

Call 1-866-923-4914

Distributed by:
Taro Pharmaceuticals U.S.A., Inc.
Hawthorne, NY 10532

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton

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

NDC 51672-2108-8

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

(Antihistamine) ALLERGY

Non-Drowsy

Indoor & Outdoor Allergies

SUGAR FREE

24
Hour
Relief of:

Ages 2 years and older

Dosing Cup
Enclosed

Bubble Gum
Flavor

When taken as directed.
See Drug Facts Panel.

4 FL OZ
(120 mL)

Principal Display Panel - 120 mL Bottle Carton
CHILDRENS LORATADINE   SUGAR FREE
loratadine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51672-2108
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
butylated hydroxyanisole (UNII: REK4960K2U)  
glycerin (UNII: PDC6A3C0OX)  
polyethylene glycol, unspecified (UNII: 3WJQ0SDW1A)  
sorbitol (UNII: 506T60A25R)  
phosphoric acid (UNII: E4GA8884NN)  
propylene glycol (UNII: 6DC9Q167V3)  
water (UNII: 059QF0KO0R)  
sodium benzoate (UNII: OJ245FE5EU)  
sodium phosphate, monobasic, dihydrate (UNII: 5QWK665956)  
Product Characteristics
ColorYELLOW (colorless to slightly yellow) Score    
ShapeSize
FlavorBUBBLE GUMImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51672-2108-81 in 1 CARTON12/08/2016
1120 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:51672-2108-11 in 1 CARTON12/08/2016
2240 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20186512/08/2016
Labeler - Taro Pharmaceuticals U.S.A., Inc. (145186370)
Establishment
NameAddressID/FEIBusiness Operations
Taro Pharmaceutical Industries Ltd.600072078MANUFACTURE(51672-2108)

Revised: 4/2021
Document Id: 31f7a7ea-9574-4641-a4ab-55f2c1f1d3e4
Set id: 96a76906-58ad-40cd-be27-4ea254e298c5
Version: 5
Effective Time: 20210416
 
Taro Pharmaceuticals U.S.A., Inc.