CHILDRENS LORATADINE  SUGAR FREE- loratadine solution 
Topco Associates LLC

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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

butylated hydroxyanisole, glycerin, grape flavor, maltitol solution, masking agent, phosphoric acid, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium phosphate monobasic dihydrate, sorbitol solution, sucralose powder.

Questions?

Call 1-888-423-0139

DISTRIBUTED BY
TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL 60007

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton

TopCare®
health

NDC 36800-131-08

COMPARE TO
CHILDREN'S CLARITIN®
ACTIVE INGREDIENT*

ORIGINAL
PRESCRIPTION STRENGTH

children's
Allergy

LORATADINE
ORAL SOLUTION USP
5 mg/ 5 mL
(ANTIHISTAMINE) / ALLERGY

• OUR PHARMACISTS
RECOMMEND •

INDOOR & OUTDOOR ALLERGIES

24
HOUR

RELIEF OF:

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.

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton
CHILDRENS LORATADINE   SUGAR FREE
loratadine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-131
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)  
sorbitol (UNII: 506T60A25R)  
polyethylene glycol, unspecified (UNII: 3WJQ0SDW1A)  
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
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-131-081 in 1 CARTON03/17/2017
1120 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07680503/17/2017
Labeler - Topco Associates LLC (006935977)

Revised: 8/2018
Document Id: 75ea11b2-e18d-4790-948d-502ba15ead27
Set id: 46161a81-f476-44f1-b93c-57869d351bd7
Version: 2
Effective Time: 20180824
 
Topco Associates LLC