Drug Facts

Active ingredient (in each 5 mL)

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.

side effects occur. You may report side effects to FDA at 1-800-FDA-1088.

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.

Directions

adults and children 6 years and over	2 teaspoonfuls daily; do not take more than 2 teaspoonfuls in 24 hours
children 2 to under 6 years of age	1 teaspoonful daily; do not take more than 1 teaspoonful in 24 hours
consumers with liver or kidney disease	ask a doctor

Other information

safety sealed: do not use if imprinted safety seal is torn or missing
store between 2° and 25°C (36° and 77°F)

Inactive ingredients

artificial grape flavor, citric acid monohydrate, glycerin, propylene glycol, purified water, sodium benzoate, sodium metabisulfite, sucrose

Distributed by:
Taro Pharmaceuticals U.S.A., Inc.
Hawthorne, NY 10532

Repackaged By:
Aidarex Pharmaceuticals, LLC.
Corona, CA 92880

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton

NDC 33261-908-01

Compare to the
active ingredient
in Claritin®*

GRAPE
FLAVOR

Original
Prescription Strength

Ages two years and older

Children's
Loratadine
Syrup
(Loratadine
Oral Solution)
5 mg/5 mL
Antihistamine

Grape Flavored Syrup

24 hour
Non-Drowsy†
Allergy Relief

Relief of:
Sneezing; Runny Nose,
Itchy, Watery Eyes,
Itchy Throat or Nose

4 FL OZ (120 mL)

† When taken as directed. See Drug Facts Panel.

CHILDRENS LORATADINE
loratadine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:33261-908(NDC:51672-2085)
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
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
SUCROSE (UNII: C151H8M554)

Product Characteristics
Color	YELLOW (colorless to slightly yellow)	Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:33261-908-01	5 mL in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA076805	08/20/2004

Labeler - Aidarex Pharmaceuticals LLC (801503249)

Childrens Loratadine