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?

1-888-287-1915

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg, Blister Carton 10 (1 x 10) Orally Disintegrating Tablets

NDC 49035-806-03
equateTM
Compare to Claritin® RediTabs® active Ingredient**
Children's Non-Drowsy*
LORATADINE ORALLY
DISINTEGRATING
Tablets USP 10 mg
Antihistamine
FOR CHILDREN SIX YEARS OF AGE OR OLDER
Indoor & Outdoor
Allergies
LASTS UP TO
24 HOURS
Relief of:

Sneezing
Runny Nose                                           Dissolves in
Itchy, Watery Eyes                               Your Mouth
Itchy Throat or Nose
*When taken as directed.                     Original
See Drug Facts Panel.                          Prescription Strength
10 (1X10) Orally Disintegrating Tablets

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:49035-806-03	1 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
Vasudha Pharma Chem Ltd.		725431626	API MANUFACTURE(49035-806)

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

Loratadine Orally Disintegrating Tablets USP 10 mg