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Childrens

CVS Pharmacy
Taro Pharmaceuticals U.S.A., Inc.

Children'sAllergy Relief


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient (in each 5 mL teaspoonful)

Loratadine 5 mg

Purpose

Antihistamine

Childrens 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 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

Childrens 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: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895

PRINCIPAL DISPLAY PANEL - 240 mL Bottle Carton

CVS
pharmacy®

NDC 59779-093-08
Compare to the
active ingredient in
Children's Claritin®†

Ages
two years
& older

NEW!

CHILDREN'S
ALLERGY
RELIEF

LORATADINE ORAL SOLUTION
5 mg / 5 mL ANTIHISTAMINE

SUGAR FREE
GRAPE FLAVORED SYRUP

24 Hour Non-Drowsy*
Allergy

Relief of:
Sneezing,
Runny nose,
Itchy, watery eyes,
Itchy throat or nose

Dye free

Indoor & Outdoor
Allergies

4 FL OZ
(120 mL)

* When taken as directed.
See Drug Facts Panel.

Childrens

Childrens

Loratadine SOLUTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:59779-093
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
GLYCERIN
sorbitol
phosphoric acid
POLYETHYLENE GLYCOLS
propylene glycol
water
SODIUM BENZOATE
SODIUM METABISULFITE
sodium phosphate, monobasic, dihydrate

Product Characteristics

Color
YELLOW (colorless to slightly yellow)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 60 in 1 BOTTLE
2 240 in 1 BOTTLE
3 120 in 1 BOTTLE
4 NDC:59779-093-08 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076805 2010-02-27


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