ALLERGY RELIEF - loratadine tablet, orally disintegrating
Ohm Laboratories Inc.

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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:

Ohm Laboratories Inc.

1385 Livingston Avenue

North Brunswick, NJ 08902

PRINCIPAL DISPLAY PANEL

Ohm

NDC 51660-527-31

Original Prescription Strength

Non-Drowsy*

24 Hour

Allergy Relief

Loratadine Orally Disintegrating Tablets, 10 mg

Antihistamine

Indoor & Outdoor Allergies

No Water Needed

Melts in Your Mouth

For Adults and Children six years and older!

Relief of:

Sneezing

Runny Nose

Itchy, Watery Eyes

Itchy Throat or Nose

30 Orally Disintegrating Tablets

*When taken as directed. See Drug Facts Panel.

30's blister carton

this is the private label distributor label for kinray Loratadine Orally Disntegrating Tabets 15s

Private Label Distributor - Kinray Loratadine Orally Disintegrating Tablets 15s

ALLERGY RELIEF
loratadine tablet, orally disintegrating

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51660-527
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LORATADINE (LORATADINE)	LORATADINE	10 mg

Inactive Ingredients
Ingredient Name	Strength
MANNITOL
CROSCARMELLOSE SODIUM
ASPARTAME
SODIUM STEARYL FUMARATE
MAGNESIUM STEARATE

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

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:51660-527-31	3 BLISTER PACK ( STRIP) in 1 CARTON	contains a BLISTER PACK (51660-527-69)
1	NDC:51660-527-69	10 TABLET, ORALLY DISINTEGRATING ( TABLET) in 1 BLISTER PACK	This package is contained within the CARTON (51660-527-31)

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

Labeler - Ohm Laboratories Inc. (184769029)

Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)

Establishment
Name	Address	ID/FEI	Operations
Ohm Laboratories Inc.		051565745	manufacture

Revised: 06/2012 Ohm Laboratories Inc.