CHILDRENS LORATADINE ODT- loratadine tablet, orally disintegrating

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

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
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MADE IN INDIA
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg, Blister Carton 30 (3 x 10) Orally Disintegrating Tablets
Walgreens
Compare to Claritin® RediTabs®
active ingredient††

NDC: 0363-4020-84
children's
ALLERGY
ORIGINAL PRESCRIPTION STRENGTH
Wal-itin®
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 throat or nose & itchy, watery eyes
- Indoor & outdoor allergies
30
ORALLY
DISINTEGRATING TABLETS

ACTUAL SIZE
6
YEARS
& OLDER

*WHEN TAKEN AS DIRECTED. SEE DRUG FACTS PANEL.

INGREDIENTS AND APPEARANCE

CHILDRENS LORATADINE ODT
loratadine tablet, orally disintegrating

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)

#	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)

CHILDRENS LORATADINE ODT by