DYE-FREE CHILDRENS LORATADINE- loratadine tablet, chewable 
PUBLIX SUPER MARKETS, INC

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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

DISTRIBUTED BY
PUBLIX SUPER MARKETS, INC.,
3300 PUBLIX CORPORATE PARKWAY
LAKELAND, FL 33811

PRINCIPAL DISPLAY PANEL - 5 mg Tablet Blister Pack Carton

NDC 56062-900-20

FOR AGES 2 YEARS AND OLDER
INDOOR & OUTDOOR ALLERGIES

children's allergy

LORATADINE CHEWABLE TABLETS USP, 5 mg

ANTIHISTAMINE

Non-drowsy*
24-hour relief of:
• Sneezing • Runny nose
• Itchy, watery eyes • Itchy throat or nose

DYE FREE

ACTUAL
SIZE

20
CHEWABLE
TABLETS

GRAPE FLAVORED

*When taken as directed. See Drug Facts Panel

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

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:56062-900
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:56062-900-202 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 - PUBLIX SUPER MARKETS, INC (006922009)
Establishment
NameAddressID/FEIBusiness Operations
Ohm Laboratories Inc.184769029MANUFACTURE(56062-900)

Revised: 1/2021
Document Id: 0970b1b1-1571-45a1-86e1-c2e85d12efff
Set id: 28a0c2b7-f793-43ac-90bc-c155ad141eaf
Version: 2
Effective Time: 20210121
 
PUBLIX SUPER MARKETS, INC