Your browser does not support JavaScript! CHILDRENS LORATADINE (LORATADINE) SOLUTION [RITE AID CORPORATION]
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RxNorm Names

CHILDRENS LORATADINE (loratadine) solution
[Rite Aid Corporation]


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
  • sneezing
  • itchy, watery eyes
  • 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
RITE AID
CORPORATION
HARRISBURG,
PA 17105

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton

RITE
AID
PHARMACY

Compare to active ingredient
in Children's Claritin®†

Original
Prescription
Strength

Children's

Loratadine
Syrup

(Loratadine
Oral Solution)
5 mg/5mL Antihistamine

Grape Flavored Syrup
Ages 2 years and older

24-Hour Allergy Relief
Non-Drowsy*

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

Principal Display Panel - 120 mL Bottle Carton
CHILDRENS LORATADINE 
loratadine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-0850
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:11822-0850-81 in 1 CARTON
1120 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07680508/20/2004
Labeler - Rite Aid Corporation (014578892)
Registrant - Taro Pharmaceuticals U.S.A., Inc (145186370)
Establishment
NameAddressID/FEIBusiness Operations
Taro Pharmaceutical Industries Ltd.600072078MANUFACTURE(11822-0850)

Revised: 11/2012
Document Id: b721e740-e60d-492e-86fd-f7b459b76d9c
Set id: 73aaa515-1931-4bb1-b337-9e7be3fae159
Version: 1
Effective Time: 20121108
 
Rite Aid Corporation

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