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Childrens Loratadine by American Sales Company

Medically reviewed on November 13, 2017

Dosage form: solution
Ingredients: Loratadine 5mg in 5mL
Labeler: American Sales Company
NDC Code: 41520-085

Children's Loratadine

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. You may report side effects to FDA at 1-800-FDA-1088.

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.

DISTRIBUTED BY: American Sales Company
4201 Walden Avenue, Lancaster, NY 14086

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

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

CAREONE®

24 HOUR/NON-DROWSY
ALLERGY RELIEF

CHILDREN'S
LORATADINE

(Loratadine Oral Solution)
5 mg/5 mL Antihistamine

Dosage Cup
Enclosed

DYE FREE

GRAPE FLAVORED
SYRUP
Ages two years and older

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

† When taken as directed.
See Drug Facts Panel.

4 FL OZ
(118 mL)

CHILDRENS LORATADINE 
loratadine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-085
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 Description
1NDC:41520-085-081 BOTTLE in 1 CARTON
1118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07680508/20/2004
Labeler - American Sales Company (809183973)
Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
Establishment
NameAddressID/FEIOperations
Taro Pharmaceutical Indutries Ltd.600072078MANUFACTURE(41520-085)

 
American Sales Company

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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