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:

runny nose
itchy, watery eyes
sneezing
itching of the nose or throat

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

use only with enclosed dosing cup

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

do not use if carton is opened, or if imprinted safety seal is broken or missing
see bottom panel for expiration date
store between 20° to 25°C (68° to 77°F)

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 HY-VEE, INC.
WEST DES MOINES, IA 50266

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton

*COMPARE TO
the Active Ingredient of
Children's
Claritin®

Hy-Vee®
health

NDC 42507-448-08

24 Hour Non-Drowsy†
Ages 2 years and older

Children's
Loratadine
Syrup

Loratadine Oral Solution
5 mg/5 mL - Antihistamine

SUGAR FREE
Indoor & Outdoor Allergies

Original Prescription Strength

Relief of:

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Nose or Throat

DYE FREE

GRAPE FLAVOR

Dosage Cup Enclosed

4 FL OZ (120 mL)

†When taken as directed.
See Drug Facts Panel

Principal Display Panel - 120 mL Bottle Carton

HY-VEE CHILDRENS LORATADINE
loratadine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:42507-448
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Loratadine (UNII: 7AJO3BO7QN) (Loratadine - UNII:7AJO3BO7QN)	Loratadine	5 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
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 (sugar free)	Imprint Code
Contains

#	Item Code	Package Description
Packaging
1	NDC:42507-448-08	1 in 1 CARTON
1		120 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA076805	02/27/2010

Labeler - HYVEE INC (006925671)

Hy-Vee® Children's Loratadine