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

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Loratadine ODT

Topco Associates LLC
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, magnesium stearate, mannitol, mint flavor, sodium stearyl fumarate, strawberry cream flavor, tutti-frutti flavor

QUESTIONS?

call 1-888-423-0139

PRINCIPAL DISPLAY PANEL

Topcare ®

NDC 36800-528-69

Ages 6 years and older

Children's MELT-IN-YOUR-MOUTH TABLETS. NO WATER NEEDED

Original Prescription Strength

24 HOUR NON-DROWSY *

Allergy Relief

LORATADINE ORALLY DISINTEGRATING TABLETS, USP 10 mg

ANTIHISTAMINE

Indoor & Outdoor Allergies

For 24 Hour Relief of:

  • Sneezing
  • Runny Nose
  • Itchy, Watery Eyes
  • Itchy Throat or Nose

COMPARE TO CLARITIN ® REDITABS ® active ingredient

10 ORALLY DISINTEGRATING TABLETS

* When taken as directed. See Drug Facts Panel.

DISTRIBUTED BY TOPCO ASSOCIATES LLC

5095193/R812

Loratadine ODT

Loratadine TABLET, ORALLY DISINTEGRATING

Product Information

Product Type Human otc drug label Item Code (Source) NDC:36800-528
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:36800-528-69 10 in 1 BLISTER PACK

Marketing Information

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


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Be sure to consult your doctor before taking any medication!
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