SUNMARK LORATADINE ODT- loratadine tablet, orally disintegrating
Sunmark

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Drug Facts

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:

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

OTHER INFORMATION

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 ® .

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)

Revised: 8/2012
Document Id: e1e28a49-a526-42b0-8a64-c3546094962f
Set id: 2aa10bc8-4d85-49c8-ad9b-7a555b26fe0d
Version: 2
Effective Time: 20120814
Sunmark