CHILDRENS ALLERGY RELIEF- loratadine solution 
Rite Aid Corporation

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Children's Allergy Relief

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 over 2 teaspoonfuls (tsp) daily; do not take more than 2 teaspoonfuls (tsp) in 24 hours
children 2 to under 6 years of age 1 teaspoonful (tsp) daily; do not take more than 1 teaspoonful (tsp) in 24 hours
children under 2 years of age ask a doctor
consumers with liver or kidney disease ask 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:
Rite Aid
30 Hunter Lane, Camp Hill, PA 17011

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton

NDC 11822-2092-8

RITE
AID®
PHARMACY

*Compare to the
active ingredient in
Children's Claritin®

ORIGINAL
PRESCRIPTION
STRENGTH

children's
allergy
relief

loratadine oral solution
5 mg/5 mL antihistamine

INDOOR & OUTDOOR ALLERGIES

NON-DROWSY
SUGAR FREE
ALCOHOL FREE
DYE FREE

grape
flavored
syrup

24 hour relief of:

sneezing
runny nose
itchy, watery eyes
itchy throat or nose

2 years & older

dosage cup
included

4 FL OZ (120 mL)

† When taken as directed. See Drug Facts Panel.

Principal Display Panel - 120 mL Bottle Carton
CHILDRENS ALLERGY RELIEF 
loratadine solution
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-2092
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Loratadine (UNII: 7AJO3BO7QN) (Loratadine - UNII:7AJO3BO7QN) Loratadine 5 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
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
Color YELLOW (colorless to slightly yellow) Score     
Shape Size
Flavor GRAPE Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:11822-2092-8 1 in 1 CARTON
1 120 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076805 02/27/2010
Labeler - Rite Aid Corporation (014578892)
Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
Establishment
Name Address ID/FEI Business Operations
Taro Pharmaceutical Industries Ltd. 600072078 MANUFACTURE(11822-2092)
Establishment
Name Address ID/FEI Business Operations
Taro Pharmaceuticals Inc. 206263295 MANUFACTURE(11822-2092)

Revised: 3/2014
Document Id: d23a822a-dccf-4193-a79a-06154f3476de
Set id: 6105d7da-629e-4c4c-96f2-0b8151d34645
Version: 3
Effective Time: 20140324
 
Rite Aid Corporation