SUNMARK LORATADINE ODT- loratadine tablet, orally disintegrating

Sunmark Loratadine ODT by

Drug Labeling and Warnings

Sunmark Loratadine ODT by is a Otc medication manufactured, distributed, or labeled by Sunmark, 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 McKesson

One Post Street, San Francisco, CA 94104

www.sunmarkbrand.com

PRINCIPAL DISPLAY PANEL

sunmark®

NDC: 49348-930-01

allergy relief

24 HOUR

loratadine Orally Disintegrating Tablets, 10 mg

Antihistamine

For adults and children six years and older

Indoor & Outdoor Allergies

Non-drowsy*

Relief of sneezing; runny nose; itchy, watery eyes; itchy throat or nose

MELTS IN YOUR MOUTH

10 ORALLY DISINTEGRATING TABLETS

*When taken as directed.

See Drug Facts Panel.

COMPARE TO CLARITIN®REDITABS®ACTIVE INGREDIENT†

†The product is not manufactured or distributed by Schering-Plough Healthcare Products , Inc.

CLARITIN®and REDITABS®are registered trademarks of Schering Corporation.

sunmark®

NDC: 49348-929-04

allergy relief

24 HOUR

Loratadine Orally Disintegrating Tablets, 10 mg

Antihistamine

For adults and children six years and older

Indoor & Outdoor Allergies

Non-drowsy*

Relief of sneezing; runny nose; itchy, watery eyes; itching of nose & throat

MELTS IN YOUR MOUTH

24 ORALLY DISINTEGRATING TABLETS

*When taken as directed.

See Drug Facts Panel.

COMPARE TO ALAVERT®ACTIVE INGREDIENT†

†The product is not manufactured or distributed by Wyeth Consumer Healthcare, owner of the registered trademark Alavert®.

INGREDIENTS AND APPEARANCE

SUNMARK LORATADINE ODT 
loratadine tablet, orally disintegrating

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49348-930
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
ASPARTAME (UNII: Z0H242BBR1)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)

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: 49348-930-01	10 in 1 BLISTER PACK
2	NDC: 49348-930-44	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

SUNMARK LORATADINE ODT 
loratadine tablet, orally disintegrating

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49348-929
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
ASPARTAME (UNII: Z0H242BBR1)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)

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: 49348-929-04	24 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 - Sunmark (177667227)

Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)

Establishment
Name	Address	ID/FEI	Business Operations
Ohm Laboratories Inc.		051565745	manufacture(49348-930, 49348-929)