Sunmark Loratadine ODT description, usages, side effects, indications, overdosage, supplying and lots more!

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Sunmark Loratadine ODT

Sunmark
Ranbaxy Pharmaceuticals Inc.

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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 ® .

Sunmark Loratadine ODT

Loratadine TABLET, ORALLY DISINTEGRATING

Product Information

Product Type Human otc drug label Item Code (Source) NDC:49348-930
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
LORATADINE loratadine 10 mg

Inactive Ingredients

Ingredient Name Strength
ASPARTAME
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
mannitol
SODIUM STEARYL FUMARATE

Product Characteristics

Color Size Imprint Code Shape
white (White to Off-White) 10 mm RC17 ROUND

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 2007-08-31


Sunmark Loratadine ODT

Loratadine TABLET, ORALLY DISINTEGRATING

Product Information

Product Type Human otc drug label Item Code (Source) NDC:49348-929
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
LORATADINE loratadine 10 mg

Inactive Ingredients

Ingredient Name Strength
ASPARTAME
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
mannitol
SODIUM STEARYL FUMARATE

Product Characteristics

Color Size Imprint Code Shape
white (White to Off White) 10 mm RC17 ROUND

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 2007-08-31


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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