PREMIER VALUE  CHILDRENS LORATADINE- loratadine solution 
Chain Drug Constortium

----------

Premier Value
Children's Loratadine

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 over2 teaspoonfuls (tsp) daily; do not take more than 2 teaspoonfuls (tsp) in 24 hours
children 2 to under 6 years of age1 teaspoonful (tsp) daily; do not take more than 1 teaspoonful (tsp) in 24 hours
children under 2 years of ageask a doctor
consumers with liver or kidney diseaseask 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
CHAIN DRUG CONSORTIUM
3301 NW BOCA RATON BLVD
SUITE 101, BOCA RATON, FL 33431

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton

NDC 68016-164-01

COMPARE TO THE
ACTIVE INGREDIENT IN
CHILDREN'S CLARITIN
®*

Premier
Value

Ages
two years
and older

Children's
Loratadine
Oral Solution
5 mg/5 mL

Antihistamine

SUGAR FREE
GRAPE
flavor

Non-Drowsy

24 hour Allergy
Relief of: Sneezing;
Runny Nose; Itchy, Watery Eyes;
Itchy Throat or Nose

INDOOR & OUTDOOR
ALLERGIES

When taken as directed.
See Drug Facts Panel.

INDEPENDENTLY TESTED
P
V

SATISFACTION GUARANTEED

4 FL OZ
(120 mL)

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton
PREMIER VALUE   CHILDRENS LORATADINE
loratadine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-164
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Loratadine (UNII: 7AJO3BO7QN) (Loratadine - UNII:7AJO3BO7QN) Loratadine5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
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
ColorYELLOW (colorless to slightly yellow) Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68016-164-011 in 1 CARTON
1120 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07680502/27/2010
Labeler - Chain Drug Constortium (101668460)
Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
Establishment
NameAddressID/FEIBusiness Operations
Taro Pharmaceutical Industries Ltd.600072078MANUFACTURE(68016-164)
Establishment
NameAddressID/FEIBusiness Operations
Taro Pharmaceuticals Inc.206263295MANUFACTURE(68016-164)

Revised: 3/2014
Document Id: 502beb77-7610-4ae2-b802-a16e07322770
Set id: e108d003-2549-443f-a3ba-5ddbd4dee3ca
Version: 3
Effective Time: 20140321
 
Chain Drug Constortium