CHILDRENS LORATADINE- loratadine solution 
Target Corporation

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Children's Loratadine Syrup

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:

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

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

Inactive ingredients

glycerin, grape flavor, maltitol solution, masking agent, noncrystallizing sorbitol solution, phosphoric acid, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium metabisulfite, sodium phosphate monobasic dihydrate, sucralose powder.

Questions?

Call 1-866-923-4914

Distributed by Target Corporation
Minneapolis, MN 55403

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton

NDC 11673-092-08

children's
loratadine syrup

loratadine oral solution, 5 mg/5 mL
antihistamine

Compare to active ingredient in
Children's Claritin®*

indoor and outdoor allergies
24-hour, non-drowsy**
allergy relief of sneezing/runny nose/
itchy, watery eyes/itchy throat or nose
sugar free, alcohol free, dye free
dosage cup enclosed
**when taken as directed
see drug facts panel

24
HOUR
RELIEF

up&up

GRAPE
FLAVOR

AGE
2+

YEARS

4 FL OZ (120 mL)

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton
CHILDRENS LORATADINE 
loratadine solution
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:11673-092
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
glycerin (UNII: PDC6A3C0OX)  
sorbitol (UNII: 506T60A25R)  
phosphoric acid (UNII: E4GA8884NN)  
polyethylene glycols (UNII: 3WJQ0SDW1A)  
propylene glycol (UNII: 6DC9Q167V3)  
water (UNII: 059QF0KO0R)  
sodium benzoate (UNII: OJ245FE5EU)  
sodium metabisulfite (UNII: 4VON5FNS3C)  
sodium phosphate, monobasic, dihydrate (UNII: 5QWK665956)  
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:11673-092-08 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 02/27/2010
Labeler - Target Corporation (006961700)
Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
Establishment
Name Address ID/FEI Business Operations
Taro Pharmaceutical Industries Ltd. 600072078 MANUFACTURE(11673-092)
Establishment
Name Address ID/FEI Business Operations
Taro Pharmaceuticals Inc. 206263295 MANUFACTURE(11673-092)

Revised: 3/2014
Document Id: b5fadc76-6bfe-48ef-97f0-fc8b7b33e524
Set id: eaf554f3-b3c1-44c0-9dc9-c1d001014b8a
Version: 3
Effective Time: 20140324
 
Target Corporation