DYE-FREE CHILDRENS LORATADINE- loratadine tablet, chewable 
RITE AID

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Dye-Free Children's Loratadine Chewable Tablets USP, 5 mg

Drug Facts

Active ingredient (in each tablet)

Loratadine USP, 5 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

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

adults and children 6 years and overchew 2 tablets daily; not more than 2 tablets in 24 hours
children 2 to under 6 years of agechew 1 tablet daily; not more than 1 tablet in 24 hours
children under 2 years of ageask a doctor
consumers with liver or kidney diseaseask a doctor

Other information

Inactive ingredients

aspartame, citric acid anhydrous, colloidal silicon dioxide, flavor, magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate, stearic acid

Questions?

call toll-free Monday to Friday 8:30 am to 5:00 pm EST at 1-800-406-7984.

DISTRIBUTED BY:
RITE AID
30 HUNTER LANE,
CAMP HILL, PA 17011

PRINCIPAL DISPLAY PANEL - 5 mg Tablet Blister Pack Carton

FREE
FROM
DYE FREE

24 HOUR

NDC 11822-8329-7

Compare to the active
ingredient of Children's
Claritin® Chewables**

AGES 2 YEARS & OLDER

CHILDREN'S
ALLERGY RELIEF

CHEWABLE TABLETS • ANTIHISTAMINE
DYE-FREE

LORATADINE CHEWABLE TABLETS USP, 5 mg
NON-DROWSY* INDOOR / OUTDOOR ALLERGIES
24 HOUR RELIEF OF
Sneezing • Runny nose • Itchy, watery eyes
Itchy throat or nose

ACTUAL SIZE

GRAPE
FLAVOR
30
CHEWABLE TABLETS

*WHEN TAKEN AS DIRECTED. SEE DRUG FACTS PANEL.

THE CHEWABLE TABLETS ARE TO BE CHEWED BEFORE SWALLOWING.

Principal Display Panel - 5 mg Tablet Blister Pack Carton
DYE-FREE CHILDRENS LORATADINE 
loratadine tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-8329
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Loratadine (UNII: 7AJO3BO7QN) (Loratadine - UNII:7AJO3BO7QN) Loratadine5 mg
Inactive Ingredients
Ingredient NameStrength
aspartame (UNII: Z0H242BBR1)  
anhydrous citric acid (UNII: XF417D3PSL)  
silicon dioxide (UNII: ETJ7Z6XBU4)  
magnesium stearate (UNII: 70097M6I30)  
mannitol (UNII: 3OWL53L36A)  
microcrystalline cellulose (UNII: OP1R32D61U)  
sodium starch glycolate type a potato (UNII: 5856J3G2A2)  
stearic acid (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorWHITE (white to off-white) Scoreno score
ShapeROUND (bevelled edge) Size10mm
FlavorGRAPEImprint Code 106
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11822-8329-73 in 1 CARTON09/01/2020
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21008809/01/2020
Labeler - RITE AID (014578892)
Establishment
NameAddressID/FEIBusiness Operations
Ohm Laboratories Inc.184769029MANUFACTURE(11822-8329)

Revised: 1/2021
Document Id: b3c8fc11-787c-4a66-9ed7-df0e0e7e0b16
Set id: dce7f475-baa9-4f19-ac49-fb1303786ace
Version: 2
Effective Time: 20210112
 
RITE AID