ASSURED ALLERGY RELIEF- loratadine tablet
Greenbrier International Inc.

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Greenbrier International Inc. Allergy Relief Drug Facts

Active ingredient (in each tablet)

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

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

•: do not use if blister unit is broken or torn
•: store between 20° to 25°C (68° to 77°F)
•: protect from excessive moisture

Inactive ingredients

lactose monohydrate, magnesium stearate, povidone, pregelatinized starch

Questions or comments?

1-800-719-9260

Principal Display Panel

COMPARE TO ACTIVE INGREDIENT OF CLARITIN®

24 HOUR

Allergy Relief

Loratadine Tablets, 10 mg – Antihistamine

Indoor & Outdoor Allergies

24 Hour Relief of: Sneezing; Runny Nose;

Itchy, Watery Eyes; Itchy Throat or Nose

Non-Drowsy*

Original Prescription Strength

*When taken as directed. See Drug Facts Panel.

Actual Size

10 Days of Relief

10 tablets

ASSURED ALLERGY RELIEF
loratadine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:33992-0612
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
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)

Product Characteristics
Color	WHITE	Score	no score
Shape	OVAL	Size	8mm
Flavor		Imprint Code	L612
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:33992-0612-1	10 in 1 CARTON	07/31/2017	01/31/2024
1		1 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	ANDA076301	07/31/2017	01/31/2024

Labeler - Greenbrier International Inc. (610322518)

Revised: 9/2023

Document Id: 992bb918-7044-432f-9b51-4fb673954b23

Set id: 1ccd9088-2c59-4a0f-a46b-4b3bddd3e901

Version: 3

Effective Time: 20230929

Greenbrier International Inc.