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

Questions?

call 1-800-406-7984

Keep the carton. It contains important information. See end panel for expiration date.

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 69842-954-30

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
Bubblegum Flavor

30 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:69842-954
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)  
cochineal (UNII: TZ8Z31B35M)  
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
Colorpink (light to medium pink with a slightly speckled appearance) Scoreno score
ShapeROUND (Flat face, beveled edge) Size10mm
FlavorBUBBLE GUMImprint Code 754
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69842-954-303 in 1 CARTON07/01/2018
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21008807/01/2018
Labeler - CVS PHARMACY, INC (062312574)
Registrant - Ohm Laboratories (051565745)
Establishment
NameAddressID/FEIBusiness Operations
Ohm Laboratories184769029MANUFACTURE(69842-954)

Revised: 8/2018
Document Id: d9290585-ce58-4f75-9974-2236d3cbc24a
Set id: 62e94727-cbb3-4c57-b241-161ab634c680
Version: 1
Effective Time: 20180803
 
CVS PHARMACY, INC