Your browser does not support JavaScript! CHILDRENS LORATADINE (LORATADINE) SOLUTION [AIDAREX PHARMACEUTICALS LLC]
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CHILDRENS LORATADINE (loratadine) solution
[Aidarex Pharmaceuticals LLC]


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. 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 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

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:
Taro Pharmaceuticals U.S.A., Inc.
Hawthorne, NY 10532

Repackaged By:
Aidarex Pharmaceuticals, LLC.
Corona, CA 92880

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton

NDC 33261-908-01

Compare to the
active ingredient
in Claritin®*

GRAPE
FLAVOR

Original
Prescription Strength

Ages two years and older

Children's
Loratadine
Syrup
(Loratadine
Oral Solution)
5 mg/5 mL
Antihistamine

Grape Flavored Syrup

24 hour
Non-Drowsy

Allergy Relief

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

4 FL OZ (120 mL)

When taken as directed. See Drug Facts Panel.

Image Label
CHILDRENS LORATADINE 
loratadine solution
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:33261-908(NDC:51672-2085)
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:33261-908-015 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07680508/20/2004
Labeler - Aidarex Pharmaceuticals LLC (801503249)

Revised: 9/2012
 
Aidarex Pharmaceuticals LLC

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