CHILDRENS LORATADINE- loratadine solution

Childrens Loratadine by

Drug Labeling and Warnings

Childrens Loratadine by is a Otc medication manufactured, distributed, or labeled by 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 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 bottle wrap imprinted with "SEALED FOR SAFETY" is broken or missing.
• see bottom panel for lot number and expiration date
• store between 20° and 25°C (68° and 77°F)

Inactive ingredients

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

Questions?

Call 1-866-923-4914

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton

NDC: 51672-2073-8

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

Original
Prescription
Strength

Children's
Loratadine
Oral Solution
USP, 5 mg/5 mL

(Antihistamine)

ALLERGY

Non-Drowsy†

24 Hour
Relief of:

• Sneezing
• Runny Nose
• Itchy, Watery Eyes
• Itchy Throat or Nose

Indoor & Outdoor Allergies

Ages 2 years and older

WARNING: Contains sodium metabisulfite,
a sulfite that may cause allergic-type reactions.

Dye Free
Fruit Flavor

Dosage Cup
Enclosed

†When taken as directed.
See Drug Facts Panel.

4 FL OZ
(120 mL)

INGREDIENTS AND APPEARANCE

CHILDRENS LORATADINE 
loratadine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51672-2073
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	FRUIT (peach)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51672-2073-8	1 in 1 CARTON	08/20/2004
1		120 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 51672-2073-4	1 in 1 CARTON	08/20/2004
2		60 mL in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 51672-2073-5	1 in 1 CARTON	08/20/2004
3		180 mL in 1 BOTTLE; Type 0: Not a Combination Product

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

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

Establishment
Name	Address	ID/FEI	Business Operations
Taro Pharmaceutical Industries Ltd.		600072078	MANUFACTURE(51672-2073)