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NDC 00363-4020-84 CHILDRENS LORATADINE ODT 10 mg/1 Details

CHILDRENS LORATADINE ODT 10 mg/1

CHILDRENS LORATADINE ODT is a ORAL TABLET, ORALLY DISINTEGRATING in the HUMAN OTC DRUG category. It is labeled and distributed by WALGREEN CO.. The primary component is LORATADINE.

MedlinePlus Drug Summary

Loratadine is used to temporarily relieve the symptoms of hay fever (allergy to pollen, dust, or other substances in the air) and other allergies. These symptoms include sneezing, runny nose, and itchy eyes, nose, or throat. Loratadine is also used to treat itching and redness caused by hives. However, loratadine does not prevent hives or other allergic skin reactions. Loratadine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms. Loratadine is also available in combination with pseudoephedrine (Sudafed, others). This monograph only includes information about the use of loratadine alone. If you are taking the loratadine and pseudoephedrine combination product, read the information on the package label or ask your doctor or pharmacist for more information.

Related Packages: 00363-4020-84
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Loratadine

Product Information

NDC	00363-4020
Product ID	0363-4020_18ac8158-eb8c-4d44-a102-8a4dfdd5299d
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	CHILDRENS LORATADINE ODT
Proprietary Name Suffix	n/a
Non-Proprietary Name	Loratadine
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, ORALLY DISINTEGRATING
Route	ORAL
Active Ingredient Strength	10
Active Ingredient Units	mg/1
Substance Name	LORATADINE
Labeler Name	WALGREEN CO.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA208477
Listing Certified Through	2024-12-31

Package

Package Images

NDC 00363-4020-84 (00363402084)

Pricing Information	N/A
NDC Package Code	0363-4020-84
Billing NDC	00363402084
Package	3 BLISTER PACK in 1 CARTON (0363-4020-84) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
Marketing Start Date	2018-04-11
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL cd597728-35fb-4e43-85ea-84af802e1983 Details

Drug Facts

Active ingredient (in each tablet)

Loratadine USP 10 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 (1-800-222-1222) right away.

Directions

place 1 tablet on tongue; tablet disintegrates, with or without water

adults and children 6 years and over	1 tablet daily; not more than 1 tablet in 24 hours
children under 6 years of age	ask a doctor
consumers with liver or kidney disease	ask a doctor

Other information

Phenylketonurics: Contains phenylalanine 2.25 mg per tablet
do not use if the individual blister unit is open or torn
store at 20° to 25°C (68° to 77°F)
use tablet immediately after opening individual blister
Complies with USP test 2 for Disintegration

Inactive ingredients

aspartame, crospovidone, mannitol, microcrystalline cellulose, peppermint, pregelatinized starch (maize), sodium stearyl fumarate

Questions or comments?

call 1-855-274-4122

DISTRIBUTED BY:

WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

Walgreens

100% SATISFACTION

GUARANTEED

walgreens.com ©2021 Walgreen Co.

MADE IN INDIA

Code: TS/DRUGS/22/2009

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg, Blister Carton 30 (3 x 10) Orally Disintegrating Tablets

NDC 0363-4020-84

Walgreens

Compare to the active ingredient

in Claritin® RediTabs®††

Junior's

Allergy Relief

LORATADINE ORALLY DISINTEGRATING

TABLETS USP 10 mg / ANTIHISTAMINE

Dissolvable Tablet

Non-Drowsy* 24 Hour

Melts in mouth with no water needed
24-hour relief of sneezing, runny nose, itchy, watery eyes & itchy throat or nose
Indoor & outdoor allergies

AGES 6 YEARS & OLDER

30 ORALLY DISINTEGRATING

TABLETS

ACTUAL SIZE

*WHEN TAKEN AS DIRECTED. SEE DRUG FACTS PANEL.

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg, Blister Carton 30 (3 x 10) Orally Disintegrating Tablets

INGREDIENTS AND APPEARANCE

CHILDRENS LORATADINE ODT

loratadine tablet, orally disintegrating

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0363-4020
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN)	LORATADINE	10 mg

Ingredient Name	Strength
Inactive Ingredients
ASPARTAME (UNII: Z0H242BBR1)
CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK)
MANNITOL (UNII: 3OWL53L36A)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
PEPPERMINT (UNII: V95R5KMY2B)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)

Product Characteristics
Color	WHITE (White to Off-white)	Score	no score
Shape	ROUND (Biconvex)	Size	8mm
Flavor	PEPPERMINT	Imprint Code	K;9
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0363-4020-84	3 in 1 CARTON	04/11/2018
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA208477	04/11/2018

Labeler - WALGREEN CO. (008965063)

Registrant - Aurohealth LLC (078728447)

Name	Address	ID/FEI	Business Operations
Establishment
Aurobindo Pharma Limited		650381903	ANALYSIS(0363-4020) , MANUFACTURE(0363-4020)

Revised: 4/2022

Document Id: 18ac8158-eb8c-4d44-a102-8a4dfdd5299d

Set id: cd597728-35fb-4e43-85ea-84af802e1983

Version: 4

Effective Time: 20220401