DYE-FREE CHILDRENS LORATADINE- loratadine tablet, chewable 
Ohm Laboratories 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:

runny nose
sneezing
itchy, watery eyes
itching of the nose or throat

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

chew or crush tablets completely before swallowing.

adults and children 6 years and over

chew 2 tablets daily; not more than 2 tablets in 24 hours

children 2 to under 6 years of age

chew 1 tablet daily; not more than 1 tablet in 24 hours

children under 2 years of age

ask a doctor

consumers with liver or kidney disease

ask a doctor

Other information

phenylketonurics: contains phenylalanine 1.25 mg per tablet.
TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
store between 20° to 25°C (68° to 77°F).

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.

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

Distributed by:
Ohm Laboratories Inc.
New Brunswick, NJ 08901

0420

PRINCIPAL DISPLAY PANEL - 5 mg Tablet Blister Pack Carton

NDC 51660-106-31

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

ages 2 years and older

Children's

Loratadine Chewable Tablets USP, 5 mg

Antihistamine

Indoor & Outdoor Allergies

30 CHEWABLE TABLETS

The chewable tablets are to be chewed before swallowing.

Dye-Free

Grape Flavored

Non-Drowsy*

24 Hour Relief of:

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose

*When taken as directed. See Drug Facts Panel.

†Ohm® is a registered trademark of Sun Pharmaceutical Industries, Inc. All other trademarks are property of their respective owners.

PDP-01
DYE-FREE CHILDRENS LORATADINE 
loratadine tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51660-106
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:51660-106-313 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 - Ohm Laboratories Inc. (184769029)
Establishment
NameAddressID/FEIBusiness Operations
Ohm Laboratories Inc.184769029MANUFACTURE(51660-106)

Revised: 9/2020
Document Id: 39374c29-01cf-43ea-a597-c07f18a91b94
Set id: 39374c29-01cf-43ea-a597-c07f18a91b94
Version: 1
Effective Time: 20200901
 
Ohm Laboratories Inc.