Your browser does not support JavaScript! QUALITY CHOICE CHILDRENS ALLERGY RELIEF (LORATADINE) SOLUTION [CHAIN DRUG MARKETING ASSOCIATION]
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QUALITY CHOICE CHILDRENS ALLERGY RELIEF (loratadine) solution
[Chain Drug Marketing Association]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL Abbreviated New Drug Application
Drug Label Sections

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:

  • 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.
  • side effects occur.

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 over2 teaspoonfuls daily; do not take more than 2 teaspoonfuls in 24 hours
children 2 to under 6 years of age1 teaspoonful daily; do not take more than 1 teaspoonful in 24 hours
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 2° and 25°C (36° and 77°F)

Inactive ingredients

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

Questions?

call 1-800-935-2362

DISTRIBUTED BY QUALITY CHOICE 43157 WEST NINE MILE ROAD
NOVI, MI 48376-0995

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

Compare to the
active ingredient in
Claritin®

QC
QUALITY
CHOICE®

NDC 63868-156-04

NON-DROWSY*

Children's
ALLERGY
RELIEF

(Loratadine
Oral Solution)
5 mg/5 mL
Antihistamine

Ages two years
and older

24 Hour
Allergy Relief

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

Grape Flavored
Syrup

4 FL OZ
(118 mL)

*When taken as directed. See Drug Facts Panel.

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton
QUALITY CHOICE   CHILDRENS ALLERGY RELIEF
loratadine solution
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:63868-156
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Loratadine (Loratadine) Loratadine5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
citric acid monohydrate 
glycerin 
propylene glycol 
water 
sodium benzoate 
sodium metabisulfite 
sucrose 
Product Characteristics
ColorYELLOW (colorless to slightly yellow) Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63868-156-041 in 1 CARTON
1118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07680508/20/2004
Labeler - Chain Drug Marketing Association (011920774)
Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
Establishment
NameAddressID/FEIBusiness Operations
Taro Pharmaceutical Industries Ltd.600072078MANUFACTURE(63868-156)

Revised: 10/2012
 
Chain Drug Marketing Association

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