TOPCARE CHILDRENS ALLERGY RELIEF- loratadine tablet, chewable 
Topco Associates LLC

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Topco Associates LLC. Children’s Allergy Relief Drug Facts

Active ingredient (in each tablet)

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

chew or crush tablets completely before swallowing

adults and children 6 years and over

chew 2 tablets daily; not more than 2 tablets in 24 hours

children 2 to under 6 years of age

chew 1 tablet daily; not more than 1 tablet in 24 hours

children under 2 years of age

ask a doctor

consumers with liver or kidney disease

ask a doctor

Other information

phenylketonurics: contains phenylalanine 1.4 mg per tablet
do not use if blister unit is broken or torn
store between 20° to 25°C (68° to 77°F)

Inactive ingredients

artificial grape flavor, aspartame, colloidal silicon dioxide, D&C red #27 aluminum lake, FD&C blue #2 aluminum lake, magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate, stearic acid

Questions or comments?

1-888-423-0139

Principal Display Panel

TopCare® health

COMPARE TO CHILDREN’S CLARITIN® ACTIVE INGREDIENT

children’s

NON-DROWSY*

Allergy Relief

LORATADINE CHEWABLE TABLETS, 5 mg • ANTIHISTAMINE

INDOOR & OUTDOOR ALLERGIES

24 HOUR

RELIEF OF:

• Sneezing

• Runny Nose

• Itchy, Watery Eyes

• Itchy Throat or Nose

2 Years & older

GRAPE FLAVOR

30 CHEWABLE TABLETS

*When taken as directed. See Drug Facts Panel.

actual size

childrens allergy relief image
TOPCARE CHILDRENS ALLERGY RELIEF 
loratadine tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-363
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE5 mg
Inactive Ingredients
Ingredient NameStrength
ASPARTAME (UNII: Z0H242BBR1)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MANNITOL (UNII: 3OWL53L36A)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorPURPLE (light) Scoreno score
ShapeROUNDSize8mm
FlavorGRAPEImprint Code L3Y8
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-363-3930 in 1 CARTON09/20/2019
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:36800-363-4940 in 1 CARTON06/20/2023
21 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21003309/20/2019
Labeler - Topco Associates LLC (006935977)

Revised: 6/2023
Document Id: d6a8c36e-4c50-4c16-96a0-2b056a050e17
Set id: 4f7555ea-6286-4ff6-b125-d12660ae4bdf
Version: 4
Effective Time: 20230620
 
Topco Associates LLC