CARE ONE  CHILDRENS LORATADINE- loratadine solution 
American Sales Company

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Care One®
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:

  • 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

  • do not use if carton is opened, or if imprinted safety seal is broken or missing
  • see bottom panel for expiration date
  • 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

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton

NDC 41520-092-08

Compare to the
Active Ingredient
in Children's
Claritin®*

CAREONE®

24 HOUR/NON-DROWSY†
SUGAR FREE

CHILDREN'S
ALLERGY RELIEF

(Loratadine Oral Solution)
5 mg/5 mL Antihistamine

Indoor & Outdoor Allergies
DYE FREE

GRAPE FLAVORED
SYRUP Ages two years and older

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

Dosage Cup
Enclosed

4 FL OZ
[120 mL]

† When taken as directed.
See Drug Facts Panel.

Principal Display Panel - 120 mL Bottle Carton
CARE ONE   CHILDRENS LORATADINE
loratadine solution
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:41520-092
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:41520-092-081 in 1 CARTON
1120 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07680502/27/2010
Labeler - American Sales Company (809183973)
Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
Establishment
NameAddressID/FEIBusiness Operations
Taro Pharmaceutical Indutries Ltd.600072078MANUFACTURE(41520-092)

Revised: 9/2013
Document Id: dbd5b66a-6f84-4547-9164-bd6b70ed62e8
Set id: 74858eac-b8de-4af3-b355-f17c95959b05
Version: 2
Effective Time: 20130906
 
American Sales Company