CHILDRENS LORATADINE- loratadine tablet, chewable 
CVS PHARMACY, INC

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CHILDREN'S LORATADINE

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, D&C red No. 27 aluminum lake, FD&C blue No. 2 aluminum lake, flavor, magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate, stearic acid

Questions?

call 1-800-406-7984

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895

PRINCIPAL DISPLAY PANEL - 5 mg Tablet Blister Pack Carton

CVS
Health

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

Indoor & Outdoor Allergies

NDC 69842-953-20

Children's
Allergy Relief
LORATADINE CHEWABLE
TABLETS USP, 5 mg
Antihistamine

24
HOUR

Non-Drowsy*

*When taken as directed.
See Drug Facts Panel.

Actual
Size

Grape
Flavor

20 CHEWABLE TABLETS
The chewable tablets are to be chewed before swallowing.

Principal Display Panel - 5 mg Tablet Blister Pack Carton
CHILDRENS LORATADINE 
loratadine tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-953
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)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
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
Colorpurple (light purple to dark purple) Scoreno score
ShapeROUNDSize10mm
FlavorGRAPEImprint Code 753
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69842-953-202 in 1 CARTON05/01/2018
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21008805/01/2018
Labeler - CVS PHARMACY, INC (062312574)
Registrant - OHM LABORATORIES INC. (184769029)
Establishment
NameAddressID/FEIBusiness Operations
Ohm Laboratories184769029MANUFACTURE(69842-953)

Revised: 2/2019
Document Id: c1f71960-9126-4c9d-a1d5-89348c888233
Set id: eca96e9e-7e8f-4e8e-8ec6-43c9fee1096c
Version: 3
Effective Time: 20190226
 
CVS PHARMACY, INC