TOPCARE CHILDRENS ALLERGY- loratadine solution 
Topco Associates LLC

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Topco Associates LLC. Children’s Allergy 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:

runny nose
itchy, watery eyes
sneezing
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 (1-800-222-1222).

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

do not use if carton is opened, or if printed neckband is broken or missing
store between 20° to 25°C (68° to 77°F)

Inactive ingredients

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

Questions or comments?

1-888-423-0139

Package/Label Principal Display Panel

TopCare® health

COMPARE TO CHILDREN’S CLARITIN® ACTIVE INGREDIENT

children’s Allergy

LORATADINE ORAL SUSPENSION USP, 5 mg/5mL (ANTIHISTAMINE) / ALLERGY

INDOOR & OUTDOOR ALLERGIES

24 HOUR

24 HOUR RELIEF OF:

• Sneezing

• Runny Nose

• Itchy, Watery Eyes

• Itchy Throat or Nose

Sugar Free & Dye Free

ALCOHOL FREE

NON-DROWSY

Dosing Cup Enclosed

Ages 2 Years and older

GRAPE FLAVOR

4 FL OZ (120 mL)

When taken as directed. See Drug Facts Panel.

childrens allergy image
TOPCARE CHILDRENS ALLERGY 
loratadine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-608
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, UNSPECIFIED FORM (UNII: 3980JIH2SW)  
PHOSPHORIC ACID (UNII: E4GA8884NN)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-608-261 in 1 CARTON07/08/2020
1120 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07572807/08/2020
Labeler - Topco Associates LLC (006935977)

Revised: 2/2022
Document Id: 3e49bf56-baef-4c33-a38b-a25794c15622
Set id: 6e175fae-05dd-45c2-b9ab-7d49369a3c05
Version: 3
Effective Time: 20220228
 
Topco Associates LLC