CHILDRENS LORATADINE- loratadine solution

Childrens Loratadine by

Drug Labeling and Warnings

Childrens Loratadine by is a Otc medication manufactured, distributed, or labeled by American Sales Company, Taro Pharmaceuticals U.S.A., Inc., Taro Pharmaceutical Indutries Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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.

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DISTRIBUTED BY: American Sales Company
4201 Walden Avenue, Lancaster, NY 14086

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

Compare to the
Active Ingredient
in Children's
Claritin®*

CAREONE®

24 HOUR/NON-DROWSY†
ALLERGY RELIEF

CHILDREN'S
LORATADINE

(Loratadine Oral Solution)
5 mg/5 mL Antihistamine

Dosage Cup
Enclosed

DYE FREE

GRAPE FLAVORED
SYRUP Ages two years and older

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

† When taken as directed.
See Drug Facts Panel.

4 FL OZ
(118 mL)

INGREDIENTS AND APPEARANCE

CHILDRENS LORATADINE 
loratadine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41520-085
Route of Administration	ORAL

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
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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41520-085-08	1 in 1 CARTON
1		118 mL in 1 BOTTLE

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

Labeler - American Sales Company (809183973)

Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)

Establishment
Name	Address	ID/FEI	Business Operations
Taro Pharmaceutical Indutries Ltd.		600072078	MANUFACTURE(41520-085)