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

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Loratadine

Innovative Manufacturing and Distribution Services, Inc.

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient

Loratadine 10mg

Purpose

Antihistamine

Loratadine 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

  • side effects occur.

You may report side effects to FDA at 1-800-FDA-1088.

If pregnant or breastfeeding

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.

Directions

  • 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.

Loratadine Other information

  • Safety sealed: do not use if the imprinted bottle seal is open or torn
  • Store at 15° - 30° C (59° - 86° F).

Inactive ingredients

Lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate.

Package/Label Principal Display Panel

Loratadine

IMDS INC.

Loratadine

(Compare to Claritin®)

30 TABLETS

10 mg

Relief of: Sneezing, Runny Nose,

Itchy Watery Eyes, Itchy Throat or Nose

Loratadine

Loratadine TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:59564-251
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
lactose monohydrate
MAGNESIUM STEARATE
cellulose, microcrystalline
SODIUM STARCH GLYCOLATE TYPE A POTATO

Product Characteristics

Color Size Imprint Code Shape
WHITE 7 mm RX526 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:59564-251-10 30 in 1 BOTTLE
2 NDC:59564-251-30 100 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076134 2008-12-01


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Be sure to consult your doctor before taking any medication!
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