CHILDRENS LORATADINE  SUGAR FREE- loratadine solution 
American Sales Company

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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 1-866-923-4914

DISTRIBUTED BY FOODHOLD U.S.A., LLC
LANDOVER, MD 20785

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton

NDC 41520-131-08

CAREone®

Compare to active ingredient
in Children's Claritin®*

Ages 2 years and Older

SUGAR
FREE

CHILDREN'S
ALLERGY

Loratadine
Oral Solution
USP, 5 mg/5 mL
(Antihistamine) Allergy

Dosing cup
enclosed

Grape
Flavor

24hr

Indoor & Outdoor Allergies
24 HOUR RELIEF OF:
• Sneezing • Runny Nose
• Itchy, Watery Eyes
• Itchy Throat or Nose

Non-drowsy
†When taken as directed. See Drug Facts Panel.
• Dye Free

OUR PHARMACISTS
Rx
RECOMMEND

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:41520-131
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:41520-131-081 in 1 CARTON07/27/2017
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 - American Sales Company (809183973)

Revised: 11/2019
Document Id: 229d491b-2951-45db-ab03-d8f79e154885
Set id: 6977d7e0-9d01-4f5e-8d55-98dabb719585
Version: 2
Effective Time: 20191120
 
American Sales Company