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Quality Choice

Chain Drug Marketing Association
Taro Pharmaceuticals U.S.A., Inc.

Quality Choice Children's Allergy Relief


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient (in each 5 mL)

Loratadine 5 mg

Purpose

Antihistamine

Quality Choice 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 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

Quality Choice 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.

Quality Choice

Quality Choice

Loratadine SOLUTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:63868-156
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
LORATADINE loratadine 5 mg

Inactive Ingredients

Ingredient Name Strength
CITRIC ACID MONOHYDRATE
GLYCERIN
propylene glycol
water
SODIUM BENZOATE
SODIUM METABISULFITE
SUCROSE

Product Characteristics

Color
YELLOW (colorless to slightly yellow)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 118 in 1 BOTTLE
2 NDC:63868-156-04 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076805 2004-08-20


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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