BEST CHOICE CHILDRENS LORATADINE  SUGAR FREE- loratadine solution 
Valu Merchandisers Company

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Best Choice® Children's Loratadine
Sugar Free

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 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

  • safety sealed: do not use if imprinted safety seal is torn or missing
  • store between 20° and 25°C (68° and 77°F)

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:
VALU MERCHANDISERS, CO.
KANSAS CITY, KS 66106

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton

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

Ages two years
and older

NDC 63941-092-08

HEALTH
Best Choice® Brand
CARE

NON-DROWSY*
24 Hour
Allergy Relief

Children's
Loratadine
Syrup

(Loratadine Oral Solution)
5 mg/5 mL
Antihistamine

Sugar Free
Grape Flavored
Syrup

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

Indoor & Outdoor Allergies

4 FL OZ
(120 mL)

*When taken as directed.
See Drug Facts Panel.

Principal Display Panel - 120 mL Bottle Carton
BEST CHOICE CHILDRENS LORATADINE   SUGAR FREE
loratadine solution
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:63941-092
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Loratadine (Loratadine) Loratadine5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
glycerin 
sorbitol 
phosphoric acid 
polyethylene glycols 
propylene glycol 
water 
sodium benzoate 
sodium metabisulfite 
sodium phosphate, monobasic, dihydrate 
Product Characteristics
ColorYELLOW (colorless to slightly yellow) Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63941-092-081 in 1 CARTON
1120 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07680502/27/2010
Labeler - Valu Merchandisers Company (868703513)
Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
Establishment
NameAddressID/FEIBusiness Operations
Taro Pharmaceutical Industries Ltd.600072078MANUFACTURE(63941-092)
Establishment
NameAddressID/FEIBusiness Operations
Taro Pharmaceuticals Inc.206263295MANUFACTURE(63941-092)

Revised: 12/2012
Document Id: 1de5a983-8ba8-4c1e-9345-15e048708494
Set id: f5ba0644-fa3d-4022-ad78-4f699af94f5f
Version: 2
Effective Time: 20121227
 
Valu Merchandisers Company