ALLERGY RELIEF- loratadine tablet, orally disintegrating

Allergy Relief by

Drug Labeling and Warnings

Allergy Relief by is a Otc medication manufactured, distributed, or labeled by Cardinal Health, Ranbaxy Pharmaceuticals Inc., Ohm Laboratories Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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 0.6 mg Per Tablet.
• TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
• store between 20° to 25° C (68° to 77° F). Protect from excessive moisture.
• keep in a dry place.
• use tablet immediately after opening individual blister.

INACTIVE INGREDIENTS

aspartame, croscarmellose sodium, fruit flavors, magnesium stearate, mannitol, sodium stearyl fumarate

QUESTIONS?

call 1-800-406-7984

Keep the carton. It contains important information. See end panel for expiration date.

DISTRIBUTED BY

CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com

1-800-200-6313

PRINCIPAL DISPLAY PANEL

LEADER®

NDC: 37205-745-65

Non-Drowsy*

ORIGINAL PRESCRIPTION STRENGTH

Allergy Relief

Loratadine Orally Disintegrating Tablets, 10 mg

Antihistamine

For Adults and Children six years and older!

No Water Needed.

Melts in Your Mouth!

Indoor & Outdoor Allergies

For 24 Hour Relief of:

sneezing; itchy, watery eyes;

runny nose; itchy throat or nose

*When taken as directed. See Drug Facts Panel.

30 ORALLY DISINTEGRATING TABLETS

Compare to Claritin® Reditabs® active ingredient†

This product is not manufactured or distributed by Schering-Plough Healthcare Products, Inc. CLARITIN® and REDITABS® are registered trademarks of Schering Corporation.

INGREDIENTS AND APPEARANCE

ALLERGY RELIEF 
loratadine tablet, orally disintegrating

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37205-745
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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
ASPARTAME (UNII: Z0H242BBR1)
MANNITOL (UNII: 3OWL53L36A)
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)
MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics
Color	white (white to off-white)	Score	no score
Shape	ROUND (flat faced beveled edge)	Size	10mm
Flavor	STRAWBERRY, TUTTI FRUTTI, MINT	Imprint Code	RC17
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37205-745-65	30 in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA077153	08/31/2007

Labeler - Cardinal Health (097537435)

Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)

Establishment
Name	Address	ID/FEI	Business Operations
Ohm Laboratories Inc.		051565745	manufacture(37205-745)