CHILDRENS LORATADINE- loratadine tablet, chewable 
Amerisource Bergen

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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, 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 AmerisourceBergen
1300 Morris Drive, Chesterbrook, PA 19087

PRINCIPAL DISPLAY PANEL - 5 mg Tablet Blister Pack Carton

GOOD
NEIGHBOR
PHARMACY®

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

NDC 46122-550-60

ages 2 years and older

Non-Drowsy*
24 HOUR

Children's
loratadine chewable tablets USP, 5 mg
antihistamine

Indoor & Outdoor Allergies

Relief of:

• Sneezing   • Runny Nose   • Itchy, Watery Eyes   • Itchy Throat or Nose

20 Chewable Tablets
The chewable tablets are to be chewed before swallowing.
*When taken as directed. See Drug Facts Panel.

actual size
grape flavor

PRINCIPAL DISPLAY PANEL - 5 mg Tablet Blister Pack Carton
CHILDRENS LORATADINE 
loratadine tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46122-550
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)  
stearic acid (UNII: 4ELV7Z65AP)  
sodium starch glycolate type a potato (UNII: 5856J3G2A2)  
Product Characteristics
ColorPURPLE (light purple to dark purple) Scoreno score
ShapeROUNDSize10mm
FlavorGRAPEImprint Code 753
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:46122-550-602 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 - Amerisource Bergen (007914906)
Establishment
NameAddressID/FEIBusiness Operations
Ohm Laboratories Inc.184769029MANUFACTURE(46122-550)

Revised: 8/2018
Document Id: 974fbe97-a712-4675-b438-afb924c92b28
Set id: 8ec562d3-9d4c-4e28-bc8e-f725079f603a
Version: 1
Effective Time: 20180807
 
Amerisource Bergen