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NDC 49035-0806-09 Loratadine ODT 10 mg/1 Details

Loratadine ODT 10 mg/1

Loratadine ODT is a ORAL TABLET, ORALLY DISINTEGRATING in the HUMAN OTC DRUG category. It is labeled and distributed by Wal-Mart Stores, Inc.. 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: 49035-0806-09
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Loratadine

Product Information

NDC	49035-0806
Product ID	49035-806_f4838dba-ad33-4f62-8544-6776be255229
Associated GPIs	41550030007220
GCN Sequence Number	030476
GCN Sequence Number Description	loratadine TAB RAPDIS 10 MG ORAL
HIC3	Z2Q
HIC3 Description	ANTIHISTAMINES - 2ND GENERATION
GCN	60521
HICL Sequence Number	007605
HICL Sequence Number Description	LORATADINE
Brand/Generic	Generic
Proprietary Name	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	Wal-Mart Stores, Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA208477
Listing Certified Through	2024-12-31

Package

Package Images

NDC 49035-0806-09 (49035080609)

Pricing Information	N/A
NDC Package Code	49035-806-09
Billing NDC	49035080609
Package	3 BLISTER PACK in 1 CARTON (49035-806-09) / 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 f399f7ab-ab51-46ff-bce9-3014eb021930 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?

DISTRIBUTED BY: Walmart Inc,.

Bentonville, AR 72716

This Product is not manufactured or distributed

by Bayer HealthCare LLC, distributor of claritin®RediTabs®

Manufactured for :

AUROHEALTH LLC

2572 Brunswick Pikg

Lawrenceville, NJ 08684

Manufactured by :

Aurobindo Pharma Limited

Unit- VII (SEZ)

Mahabubnagar (Dt) -509302

India

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

NDC 49035-806-09

equateTM

Compared to

the active

Ingredient

In Claritin®

RediTabs®**

Non-Drowsy*

Loratadine Orally Disintegrating Dissolves

Tablets USP 10 mg in Your Mouth

Antihistamine

Indoor & Outdoor Allergy Relief

24 Hour Relief Of:

Sneezing
Runny nose 24
Itchy, watery eyes HOUR
Itchy throat or nose

Original Prescription Strength

30

*When taken as directed. See Drug Facts Panel. TABLETS (3 x 10) Orally Disintegrating Tablets

INGREDIENTS AND APPEARANCE

LORATADINE ODT

loratadine tablet, orally disintegrating

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49035-806
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 (15 MPA.S AT 5%) (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:49035-806-09	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 - Wal-Mart Stores, Inc. (051957769)

Registrant - Aurohealth LLC (078728447)

Name	Address	ID/FEI	Business Operations
Establishment
Aurobindo Pharma Limited		650381903	ANALYSIS(49035-806) , MANUFACTURE(49035-806)

Revised: 11/2022

Document Id: f4838dba-ad33-4f62-8544-6776be255229

Set id: f399f7ab-ab51-46ff-bce9-3014eb021930

Version: 4

Effective Time: 20221104