CHILDRENS  ALLERGY RELIEF- loratadine solution 
CVS Pharmacy

----------

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

glycerin, grape flavor, maltitol solution, masking agent, noncrystallizing sorbitol solution, phosphoric acid, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium metabisulfite, 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 59779-093-08

Children's
Allergy

24
HOUR

LORATADINE
ORAL SOLUTION
USP, 5 mg/5 mL
(Antihistamine)
ALLERGY

Non-Drowsy*

WARNING: Contains sodium metabisulfite,
a sulfite that may cause allergic-type reactions.

*When taken as directed.
See Drug Facts Panel.

Grape Flavor
Dosing Cup Enclosed

4 FL OZ (120 mL)

Principal Display Panel - 120 mL Bottle Carton
CHILDRENS   ALLERGY RELIEF
loratadine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-093
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
glycerin (UNII: PDC6A3C0OX)  
sorbitol (UNII: 506T60A25R)  
phosphoric acid (UNII: E4GA8884NN)  
polyethylene glycols (UNII: 3WJQ0SDW1A)  
propylene glycol (UNII: 6DC9Q167V3)  
water (UNII: 059QF0KO0R)  
sodium benzoate (UNII: OJ245FE5EU)  
sodium metabisulfite (UNII: 4VON5FNS3C)  
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:59779-093-041 in 1 CARTON
160 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:59779-093-011 in 1 CARTON
2240 mL in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:59779-093-081 in 1 CARTON
3120 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07680502/27/2010
Labeler - CVS Pharmacy (062312574)
Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
Establishment
NameAddressID/FEIBusiness Operations
Taro Pharmaceutical Industries Ltd.600072078MANUFACTURE(59779-093)
Establishment
NameAddressID/FEIBusiness Operations
Taro Pharmaceuticals Inc.206263295MANUFACTURE(59779-093)

Revised: 1/2016
Document Id: f5707614-e901-4611-8328-60d8447dc326
Set id: 1d53a4c5-576a-4d1b-af8e-180daea093b8
Version: 5
Effective Time: 20160127
 
CVS Pharmacy