CHILDRENS NON-DROWSY 24-HOUR ALLERGY RELIEF- loratadine solution

Childrens Non-Drowsy by

Drug Labeling and Warnings

Childrens Non-Drowsy by is a Otc medication manufactured, distributed, or labeled by Safeway Inc., Taro Pharmaceuticals U.S.A., Inc., Taro Pharmaceutical Industries 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.

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

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY SAFEWAY INC.
P.O. BOX 99, PLEASANTON, CA 94566-0009

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton

NDC: 21130-787-29

Compare to
Children's Claritin®
active ingredient†

Children's
Non-Drowsy*

24-Hour
Allergy Relief

Loratadine Oral Solution
5 mg/5 mL
Antihistamine

Relieves:

• Sneezing
• Runny Nose
• Itchy, Watery Eyes
• Itching of Nose & Throat

Ages two years and older

*When taken as directed.
See Drug Facts panel.

Dosage cup enclosed
Dye-Free

Grape Flavored
Alcohol Free

4 FL OZ
(120 mL)

SAFEWAY ™

INGREDIENTS AND APPEARANCE

CHILDRENS NON-DROWSY   24-HOUR ALLERGY RELIEF
loratadine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 21130-787
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: 21130-787-29	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	08/20/2004

Labeler - Safeway Inc. (009137209)

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

Establishment
Name	Address	ID/FEI	Business Operations
Taro Pharmaceutical Industries Ltd.		600072078	MANUFACTURE(21130-787)