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

  • 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:
Rite Aid
30 Hunter Lane, Camp Hill, PA 17011

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton

NDC 11822-2092-8

RITE
AID®
PHARMACY

*Compare to the
active ingredient in
Children's Claritin®

ORIGINAL
PRESCRIPTION
STRENGTH

children's
allergy
relief

loratadine oral solution
5 mg/5 mL antihistamine

INDOOR & OUTDOOR ALLERGIES

NON-DROWSY
SUGAR FREE
ALCOHOL FREE
DYE FREE

grape
flavored
syrup

24 hour relief of:

sneezing
runny nose
itchy, watery eyes
itchy throat or nose

2 years & older

dosage cup
included

4 FL OZ (120 mL)

† When taken as directed. See Drug Facts Panel.

Principal Display Panel - 120 mL Bottle Carton
CHILDRENS ALLERGY RELIEF 
loratadine solution
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:11822-2092
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:11822-2092-81 in 1 CARTON
1120 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07680502/27/2010
Labeler - Rite Aid Corporation (014578892)
Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
Establishment
NameAddressID/FEIBusiness Operations
Taro Pharmaceutical Industries Ltd.600072078MANUFACTURE(11822-2092)
Establishment
NameAddressID/FEIBusiness Operations
Taro Pharmaceuticals Inc.206263295MANUFACTURE(11822-2092)

Revised: 3/2014
 
Rite Aid Corporation

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