LORATADINE- loratadine solution 
Taro Pharmaceuticals Industries, Ltd.

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Loratadine Syrup

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:

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

Inactive ingredients

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

DISTRIBUTED BY RITE AID CORPORATION
HARRISBURG, PA 17105
Made in Israel. 72700-0509-0 575

PRINCIPAL DISPLAY PANEL - 4 FL OZ Label

Original
Prescription
Strength
RITE
AID
PHARMACY

Children's
Loratadine
Syrup

(Loratadine
Oral Solution)
5 mg/5mL Antihistamine
4 FL OZ (120 mL)

Principle Display Panel - 4 FL OZ Label

PRINCIPAL DISPLAY PANEL - 4 FL OZ carton

RITE
AID
PHARMACY

Compare to active ingredient
in Children's Claritin® †
Original
Prescription
Strength

Children's
Loratadine
Syrup

(Loratadine
Oral Solution)
5 mg/5mL Antihistamine

Grape Flavored Syrup
Ages 2 years and older

24-Hour Allergy Relief
Non-Drowsy*

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

Principle Display Panel - 4 FL OZ carton
LORATADINE 
loratadine solution
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:52549-2085
Route of Administration ORAL DEA Schedule     
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 (Clear, colorless to light yellow) Score     
Shape Size
Flavor GRAPE Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:52549-2085-8 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 - Taro Pharmaceuticals Industries, Ltd. (600072078)
Establishment
Name Address ID/FEI Business Operations
Taro Pharmaceuticals Industries, Ltd. 600072078 MANUFACTURE

Revised: 7/2009
Document Id: 12ba6dc3-25db-4c80-aff5-f67c0f72f5f5
Set id: f12eb5ec-2eb4-4990-9f43-73469c2744d3
Version: 1
Effective Time: 20090730
 
Taro Pharmaceuticals Industries, Ltd.