Loratadine by WALGREEN CO. / Aurohealth LLC / Aurobindo Pharma Limited LORATADINE tablet

Loratadine by

Drug Labeling and Warnings

Loratadine by is a Otc medication manufactured, distributed, or labeled by WALGREEN CO., Aurohealth LLC, Aurobindo Pharma Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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                                                                    
• itchy, watery eyes
• sneezing 
• 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

• Tamper-evident: do not use if foil seal under cap, printed with “SEALED for YOUR PROTECTION” is missing, open or broken
• store at 20° to 25°C (68° to 77°F)
• protect from excessive moisture

Inactive ingredients

lactose monohydrate, magnesium stearate, pregelatinized starch (maize), sodium starch glycolate.

Questions or comments?

call 1-855-274-4122

DISTRIBUTED BY:
WALGREEN CO.
DEERFIELD, IL 60015

100% SATISFACTION GUARANTEED

walgreens.com ©2024 Walgreen Co.

MADE IN INDIA

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg Container Label (30 Tablets)

Walgreens
NON-DROWSY‡

Allergy Relief
Loratadine tablets USP 10 mg, antihistamine

24 hour   |  indoor & outdoor allergies
Relief of sneezing; runny nose; itchy,
watery eyes; & itchy throat or nose

‡WHEN TAKEN AS DIRECTED.
SEE RUG FACTS PANEL.

30
tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg Container Carton Label (30 Tablets)

Walgreens
free + pure†
NON- DROWSY‡

Allergy Relief
Loratadine tablets USP 10 mg, antihistamine

Compare to the active ingredient in Claritin®††
24 hour |  indoor & outdoor allergies
Relief of sneezing; runny nose; itchy,
watery eyes; & itchy throat or nose

Free + Pure is:
    No artificial flavors
    No synthetic colors
    Gluten free*
    Non- GMO
  

‡WHEN TAKEN AS DIRECTED. SEE DRUG FACTS PANEL.

Actual size                Not actual size

30 tablets

INGREDIENTS AND APPEARANCE

LORATADINE 
loratadine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-9603
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

Product Characteristics
Color	WHITE (White to Off-white)	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code	39;L
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-9603-09	1 in 1 CARTON	07/03/2021
1		30 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA208314	07/03/2021

Labeler - WALGREEN CO. (008965063)

Registrant - Aurohealth LLC (078728447)

Establishment
Name	Address	ID/FEI	Business Operations
Aurobindo Pharma Limited		650381903	ANALYSIS(0363-9603) , MANUFACTURE(0363-9603)