CHILDRENS ALLERGY- loratadine solution 
CVS Pharmacy

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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:

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: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton

CVS
Health

Compare to the active
ingredient in Children's Claritin®

Indoor & Outdoor
Allergies

NDC 69842-535-08

Children's
Allergy

24
HOUR

LORATADINE
ORAL SOLUTION USP

5 mg/5 mL

Antihistamine

Allergy

Indoor & Outdoor Allergies

Non-Drowsy*

24 hour relief of:

Sneezing; Runny nose; Itchy,
watery eyes; Itchy throat or nose

Sugar free

2 Years & Older

*When taken as directed.
See Drug Facts Panel.

DYE
FREE

Bubble Gum Flavor

Dosing Cup Enclosed

4 FL OZ (120 mL)

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton
CHILDRENS ALLERGY 
loratadine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-535
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
FlavorBUBBLE GUMImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69842-535-081 in 1 CARTON12/12/2016
1120 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20186512/12/2016
Labeler - CVS Pharmacy (062312574)

Revised: 10/2017
Document Id: 5e079d68-d863-485e-b46f-d9a6c4fbface
Set id: dc5f58ef-baf0-4de4-9f6d-aedee419b59b
Version: 4
Effective Time: 20171002
 
CVS Pharmacy