309 - Allergy Relief

Active ingredient

Loratadine 10 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

■ sneezing

■ runny nose

■ 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. You may report side effects to 1-888-952-0050.

Pregnancy/Breastfeeding

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children

Keep out of reach of children. In case of accidental overdose, contact a doctor or Poison Control Center immediately.

Directions

Adults and children 6 years and over 1 tablet daily: no 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

■ store between 20° to 25° C (68° to 77° F)

■ protect from excessive moisture

■ do not use if blister unit is torn or open

Inactive ingredients

croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, silicon dioxide

Principal Display Panel

Allergy Relief

ALLERGY RELIEF
loratadine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68998-309
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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	white	Score	no score
Shape	OVAL	Size	6mm
Flavor		Imprint Code	LOR;10;APO
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:68998-309-85	2 in 1 CARTON	12/16/2014	03/31/2023
1		15 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	ANDA076471	12/16/2014	03/31/2023

Labeler - Marc Glassman, Inc. (094487477)

Revised: 12/2016

Document Id: c8afb069-7ce7-405e-a75a-dc7520611b1a

Set id: 26cc9474-0ac2-4384-abc0-1679d0b16b9b

Version: 5

Effective Time: 20161221

Marc Glassman, Inc.